- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00367133
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (IVT)
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:
- Laser photocoagulation
- 1mg intravitreal triamcinolone acetonide injection
- 4mg intravitreal triamcinolone acetonide injection
For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).
The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.
Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.
Visão geral do estudo
Status
Condições
Descrição detalhada
Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the prevalence of diabetic macular edema is approximately 20% in patients with type 1 diabetes mellitus (DM), 25% in patients with type 2 DM who are taking insulin, and 14% in patients with type 2 DM who do not take insulin.
In a review of three early studies concerning the natural history of diabetic macular edema, Ferris and Patz found that 53% of 135 eyes with diabetic macular edema, presumably all involving the center of the macula, lost two or more lines of visual acuity over a two year period. In the Early Treatment Diabetic Retinopathy Study (ETDRS), 33% of 221 untreated eyes available for follow-up at the 3-year visit, all with edema involving the center of the macula at baseline, had experienced a 15 or more letter decrease in visual acuity score (equivalent to a doubling of the visual angle, e.g., 20/25 to 20/50, and termed "moderate visual acuity loss").
In the ETDRS, focal/grid photocoagulation of eyes with clinically significant macular edema (CSME) reduced the risk of moderate visual loss by approximately 50% (from 24% to 12%, three years after initiation of treatment). Therefore, 12% of treated eyes developed moderate visual loss in spite of treatment. Furthermore, approximately 40% of treated eyes that had retinal thickening involving the center of the macula at baseline still had thickening involving the center at 12 months, as did 25% of treated eyes at 36 months.
Although several treatment modalities are currently under investigation, the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation, as demonstrated by the ETDRS, and intensive glycemic control, as demonstrated by the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS). In the DCCT, intensive glucose control reduced the risk of onset of diabetic macular edema by 23% compared with conventional treatment. Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control, with a 58% risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study.
The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities. One such treatment is pars plana vitrectomy. These studies suggest that vitreomacular traction, or the vitreous itself, may play a role in increased retinal vascular permeability. Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity. However, this treatment may be applicable only to a specific subset of eyes with diabetic macular edema. It also requires a complex surgical intervention with its inherent risks, recovery time, and expense. Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor (VEGF) are under investigation. The use of intravitreal corticosteroids is another treatment modality that has generated recent interest.
The optimal dose of corticosteroid to maximize efficacy with minimum side effects is not known. A 4mg dose of Kenalog is principally being used in clinical practice. However, this dose has been used based on feasibility rather than scientific principles.
There is also experience using Kenalog doses of 1mg and 2mg. These doses anecdotally have been reported to reduce the macular edema. There is a rationale for using a dose lower than 4mg. Glucocorticoids bind to glucocorticoid receptors in the cell cytoplasm, and the steroid-receptor complex moves to the nucleus where it regulates gene expression. The steroid-receptor binding occurs with high affinity (low dissociation constant (Kd) which is on the order of 5 to 9 nanomolar). Complete saturation of all the receptors occurs about 20-fold higher levels, i.e., about 100-200 nanomolar. A 4mg dose of triamcinolone yields a final concentration of 7.5 millimolar, or nearly 10,000-fold more than the saturation dose. Thus, the effect of a 1mg dose may be equivalent to that of a 4mg dose, because compared to the 10,000-fold saturation, a 4-fold difference in dose is inconsequential. It is also possible that higher doses of corticosteroid could be less effective than lower doses due to down-regulation of the receptor. The steroid implant studies provide additional justification for evaluating a lower dose, a 0.5mg device which delivers only 0.5 micrograms per day has been observed to have a rapid effect in reducing macular edema.
There has been limited experience using doses greater than 4mg. Jonas' case series reported results using a 25mg dose. However, others have not been able to replicate this dose using the preparation procedure described by Jonas.
In the trial, 4mg and 1mg doses will be evaluated. The former will be used because it is the dose that is currently most commonly used in clinical practice and the latter because there is reasonable evidence for efficacy and the potential for lower risk. Although there is good reason to believe that a 1mg dose will reduce the macular edema, it is possible that the retreatment rate will be higher with this dose compared with 4mg since the latter will remain active in the eye for a longer duration than the former. Insufficient data are available to warrant evaluating a dose higher than 4mg at this time.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205-7199
- Jones Eye Institute/University of Arkansas for Medical Sciences
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California
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Baldwin Park, California, Estados Unidos, 91706
- SCPMG Regional Offices - Kaiser Permanente
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Beverly Hills, California, Estados Unidos, 90211
- Retina-Vitreous Associates Medical Group
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Irvine, California, Estados Unidos, 92697
- University of California, Irvine
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Health Care, Dept. of Ophthalmology
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Los Angeles, California, Estados Unidos, 90033
- Doheny Eye Institute
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Los Angeles, California, Estados Unidos, 90095
- Jules Stein Eye Institute
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Palm Springs, California, Estados Unidos, 92262
- Southern California Desert Retina Consultants, MC
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San Francisco, California, Estados Unidos, 94107
- West Coast Retina Medical Group, Inc.
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Santa Ana, California, Estados Unidos, 92705
- Orange County Retina Medical Group
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Santa Barbara, California, Estados Unidos, 93103
- California Retina Consultants
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Walnut Creek, California, Estados Unidos, 94598
- Bay Area Retina Associates
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Colorado
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Denver, Colorado, Estados Unidos, 80204
- Denver Health Medical Center
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Louisville, Colorado, Estados Unidos, 80027
- Eldorado Retina Associates, P.C.
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519-1600
- Connecticut Retina Consultants
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New Haven, Connecticut, Estados Unidos, 06519
- Connecticut Retina Consultants
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Florida
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Fort Myers, Florida, Estados Unidos, 33912
- National Ophthalmic Research Institute
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Ft. Lauderdale, Florida, Estados Unidos, 33334
- Retina Group of Florida
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Lakeland, Florida, Estados Unidos, 33805
- Central Florida Retina Institute
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Lakeland, Florida, Estados Unidos, 33805
- Florida Retina Consultants
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Retina Institute
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Tampa, Florida, Estados Unidos, 33603
- International Eye Center
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Georgia
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Augusta, Georgia, Estados Unidos, 30909
- Southeast Retina Center, P.C.
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Hawaii
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Aiea, Hawaii, Estados Unidos, 96701
- Retina Consultants of Hawaii, Inc.
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Honolulu, Hawaii, Estados Unidos, 96813
- Retina Associates of Hawaii, Inc.
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Medical Faculty Foundation
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Joliet, Illinois, Estados Unidos, 60435
- Illinois Retina Associates
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46290
- Raj K. Maturi, M.D., P.C.
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New Albany, Indiana, Estados Unidos, 47150
- John-Kenyon American Eye Institute
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509-1802
- Retina and Vitreous Associates of Kentucky
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Paducah, Kentucky, Estados Unidos, 42001
- Paducah Retinal Center
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Maine Vitreoretinal Consultants
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Maryland
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Baltimore, Maryland, Estados Unidos, 21237
- Elman Retina Group, P.A.
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Baltimore, Maryland, Estados Unidos, 21287-9277
- Wilmer Ophthalmological Institute at Johns Hopkins
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Greenbelt, Maryland, Estados Unidos, 20770-3502
- The Retina Group of Washington
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Salisbury, Maryland, Estados Unidos, 21801
- Retina Consultants of Delmarva, P.A.
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Joslin Diabetes Center
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Boston, Massachusetts, Estados Unidos, 02114
- Ophthalmic Consultants of Boston
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
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Detroit, Michigan, Estados Unidos, 48201-1423
- Kresge Eye Institute
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Grand Rapids, Michigan, Estados Unidos, 49546
- Associated Retinal Consultants
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Royal Oak, Michigan, Estados Unidos, 48073
- Vision Research Foundation
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Retina Center, PA
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Barnes Retina Institute
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St. Louis, Missouri, Estados Unidos, 63104
- St. Louis University Eye Institute
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New Jersey
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Lawrenceville, New Jersey, Estados Unidos, 08648
- Delaware Valley Retina Associates
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New York
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New York, New York, Estados Unidos, 10003
- The New York Eye and Ear Infirmary/Faculty Eye Practice
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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Slingerlands, New York, Estados Unidos, 12159
- Retina Consultants, PLLC
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Syracuse, New York, Estados Unidos, 13224
- Retina-Vitreous Surgeons of Central New York, PC
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina, Dept. of Ophthalmology
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Charlotte, North Carolina, Estados Unidos, 28210
- Charlotte Eye Ear Nose and Throat Assoc, PA
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Charlotte, North Carolina, Estados Unidos, 28211
- Horizon Eye Care, PA
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Eye Center
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
- Retina Associates of Cleveland, Inc.
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Dublin, Ohio, Estados Unidos, 43017
- OSU Eye Physicians and Surgeons, LLC.
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Dean A. McGee Eye Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Casey Eye Institute
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Portland, Oregon, Estados Unidos, 97210
- Retina Northwest, PC
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State College of Medicine
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania Scheie Eye Institute
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Retina Consultants
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29223
- Carolina Retina Center
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Columbia, South Carolina, Estados Unidos, 29169
- Palmetto Retina Center
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Black Hills Regional Eye Institute
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37909
- Southeastern Retina Associates, P.C.
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Texas
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Abilene, Texas, Estados Unidos, 79605
- West Texas Retina Consultants P.A.
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Arlington, Texas, Estados Unidos, 76012
- Texas Retina Associates
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Austin, Texas, Estados Unidos, 78705
- Retina Research Center
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Dallas, Texas, Estados Unidos, 75231
- Texas Retina Associates
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Galveston, Texas, Estados Unidos, 77555-1106
- University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences
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Houston, Texas, Estados Unidos, 77030
- Retina Consultants of Houston, PA
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Houston, Texas, Estados Unidos, 77025
- Retina and Vitreous of Texas
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Houston, Texas, Estados Unidos, 77002
- Charles A. Garcia, PA & Associates
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Lubbock, Texas, Estados Unidos, 79424
- Texas Retina Associates
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McAllen, Texas, Estados Unidos, 78503
- Valley Retina Institute
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Rocky Mountain Retina Consultants
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin-Madison, Dept. of Ophthalmology
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wiconsin
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
To be eligible, the following inclusion criteria must be met:
- Age ≥18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Able and willing to provide informed consent.
- Patient understands that (1) if both eyes are eligible at the time of randomization, one eye will receive intravitreal triamcinolone acetonide and one eye will receive laser, and (2) if only one eye is eligible at the time of randomization and the fellow eye develops DME later, then the fellow eye will not receive intravitreal triamcinolone acetonide if the study eye received intravitreal triamcinolone acetonide (however, if the study eye was assigned to the laser group, then the fellow eye may be treated with the 4mg dose of the study intravitreal triamcinolone acetonide formulation, provided the eye assigned to laser has not received an intravitreal injection; such an eye will not be a "study eye" but since it is receiving study drug, it will be followed for adverse effects).
Exclusion Criteria
A patient is not eligible if any of the following exclusion criteria are present:
7. History of chronic renal failure requiring dialysis or kidney transplant.
8. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Note: Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
9. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
10. Known allergy to any corticosteroid or any component of the delivery vehicle.
11. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
12. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.
13. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). Note: If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
Study Eye Eligibility
Inclusion
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (e-ETDRS) visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤73 letters (i.e., 20/40 or worse).
- Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
- Mean retinal thickness on two Optical Coherence Tomography (OCT) measurements ≥250 microns in the central subfield.
Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
Exclusion
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of prior treatment with intravitreal corticosteroids.
- History of peribulbar steroid injection within 6 months prior to randomization.
- History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.Note: Patients are not required to have had prior macular photocoagulation to be enrolled. If prior macular photocoagulation has been performed, the investigator should believe that the patient may possibly benefit from additional photocoagulation.
- History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization.
- Anticipated need for PRP in the 4 months following randomization.
- History of prior pars plana vitrectomy.
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 6 months following randomization.
- History of YAG capsulotomy performed within 2 months prior to randomization.
- Intraocular pressure ≥25 mmHg.
- History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma.) Note: Angle-closure glaucoma is not an exclusion. A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure (IOP) is <25 mm Hg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous. If the intraocular pressure is 22 to <25 mm Hg, then the above criteria for ocular hypertension eligibility must be met.
- History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
- History of prior herpetic ocular infection.
- Exam evidence of ocular toxoplasmosis.
- Aphakia.
- Exam evidence of pseudoexfoliation.
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
In patients with only one eye meeting criteria to be a study eye at the time of randomization, the fellow eye must meet the following criteria:
- Best corrected e-ETDRS visual acuity score ≥19 letters (i.e., 20/400 or better).
- No prior treatment with intravitreal corticosteroids.
- Intraocular pressure < 25 mmHg.
- No history of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma.)Note: Angle-closure glaucoma is not an exclusion. A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure is <25 mmHg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous. If the intraocular pressure is 22 to <25 mmHg, then the above criteria for ocular hypertension eligibility must be met.
- No history of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
- No exam evidence of pseudoexfoliation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 1
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
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Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Outros nomes:
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Experimental: 2
Intravitreal injection of 1mg of triamcinolone acetonide
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Intravitreal injection of 1mg of triamcinolone acetonide at baseline.
At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment.
Retreatment, when indicated, will be performed within four weeks after the follow-up visit.
Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
Outros nomes:
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Experimental: 3
Intravitreal injection of 4mg of triamcinolone acetonide
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4mg intravitreal triamcinolone acetonide injection at baseline.
At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment.
Retreatment, when indicated, will be performed within four weeks after the follow-up visit.
Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Prazo: Baseline to 2 Years
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
A positive change denotes an improvement.
Best value on the scale 97, worst 0.
|
Baseline to 2 Years
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Median Change in Visual Acuity Baseline to 2 Years
Prazo: Baseline to 2 Years
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
A positive change denotes an improvement.
|
Baseline to 2 Years
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Distribution of Change in Visual Acuity Baseline to 2 Years
Prazo: baseline to 2 years
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
|
baseline to 2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Central Subfield Thickness at 2 Years
Prazo: 2 Years
|
Median central subfield thickness at two-years.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
|
2 Years
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Mean Change in Central Subfield Thickness Baseline to 2 Years
Prazo: Baseline to 2 years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Negative change denotes and improvement.
|
Baseline to 2 years
|
Median Change in Central Subfield Thickness Baseline to 2 Years
Prazo: Baseline to 2 Years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Negative change denotes an improvement.
|
Baseline to 2 Years
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Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Prazo: Baseline to 2 Years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
|
Baseline to 2 Years
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Central Subfield Thickness < 250 Microns at 2 Years
Prazo: 2 Years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
|
2 Years
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Change in Visual Acuity From Baseline to 3 Years
Prazo: Baseline to 3 year
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
A positive change denotes an improvement.
|
Baseline to 3 year
|
Change in Visual Acuity From Baseline to 3 Years
Prazo: Baseline to 3 year
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
A positive change denotes an improvement.
Best Value on the scale=97, Worst Value=0
|
Baseline to 3 year
|
Distribution of Visual Acuity Change Baseline to 3 Years
Prazo: Baseline to 3 years
|
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
A positive change denotes an improvement.
Best value on the scale=97, worst=0
|
Baseline to 3 years
|
Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years
Prazo: 3 years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
|
3 years
|
Change in Central Subfield Thickness on OCT Baseline to 3 Years
Prazo: Baseline to 3 years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Negative change denotes an improvement.
|
Baseline to 3 years
|
Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years
Prazo: Baseline to 3 years
|
Overall central subfield change from baseline.
Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine.
The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.
Negative change denotes an improvement.
|
Baseline to 3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Michael Ip, M.D., University of Wisconsin Medical School
Publicações e links úteis
Publicações Gerais
- Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.
- Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
- Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.
- Ip MS, Bressler SB, Antoszyk AN, Flaxel CJ, Kim JE, Friedman SM, Qin H; Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone and focal/grid photocoagulation for diabetic macular edema: baseline features. Retina. 2008 Jul-Aug;28(7):919-30. doi: 10.1097/IAE.0b013e31818144a7.
- Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10. doi: 10.1016/j.ophtha.2008.06.015. Epub 2008 Jul 26.
- Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.
- Aiello LP, Edwards AR, Beck RW, Bressler NM, Davis MD, Ferris F, Glassman AR, Ip MS, Miller KM; Diabetic Retinopathy Clinical Research Network. Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2010 May;117(5):946-53. doi: 10.1016/j.ophtha.2009.10.002. Epub 2010 Feb 1.
- Bressler NM, Edwards AR, Beck RW, Flaxel CJ, Glassman AR, Ip MS, Kollman C, Kuppermann BD, Stone TW; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of diabetic retinopathy progression through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with focal/grid photocoagulation. Arch Ophthalmol. 2009 Dec;127(12):1566-71. doi: 10.1001/archophthalmol.2009.308.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças oculares
- Degeneração Retiniana
- Doenças Retinianas
- Degeneração macular
- Edema Macular
- Edema
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Antiinflamatórios
- Agentes imunossupressores
- Fatores imunológicos
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Triancinolona
- Triancinolona Acetonida
- Hexacetonido de triancinolona
- Diacetato de triancinolona
Outros números de identificação do estudo
- NEI-105
- U10EY018817-03 (Concessão/Contrato do NIH dos EUA)
- U10EY014231-09 (Concessão/Contrato do NIH dos EUA)
- U10EY014229-07 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Edema macular diabético
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University of Modena and Reggio EmiliaConcluídoDegeneração macular avançada | Degeneração Macular Seca | Degeneração Macular Senil | Cicatriz macular | Degeneração macular não exsudativaItália
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Innovent Biologics (Suzhou) Co. Ltd.SuspensoEdema macular diabético | Degeneração macular relacionada à idade neovascularChina
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Ashvattha Therapeutics, Inc.ConcluídoEdema macular diabético | Degeneração macular relacionada à idade neovascularAustrália
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Vitreo-Retinal Associates, MichiganVan Andel Research InstituteConcluídoEdema macular diabético | Degeneração macular exsudativaEstados Unidos
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Hoffmann-La RocheConcluídoEdema macular diabético | Degeneração macular relacionada à idade neovascularEstados Unidos
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The Lowy Medical Research Institute LimitedDesconhecidoPigmento macular | Teleangiectasia MacularAlemanha
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Mid-Atlantic Retina Consultations, Inc.West Virginia UniversityDesconhecidoEdema macular diabético | Degeneração macular relacionada à idade neovascularEstados Unidos
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AiViva BioPharma, Inc.RecrutamentoEdema macular diabético | Degeneração macular relacionada à idade neovascularEstados Unidos
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Regeneron PharmaceuticalsAinda não está recrutandoEdema macular diabético (EMD) | Degeneração macular relacionada à idade neovascular (nAMD)
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EyeBiotech Ltd.RecrutamentoEdema macular diabético (EMD) | Degeneração macular relacionada à idade neovascular (NVAMD)Estados Unidos, Argentina, Porto Rico, Reino Unido
Ensaios clínicos em Standard of Care Group
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Compedica IncProfessional Education and Research InstituteRecrutamentoÚlcera do pé diabéticoEstados Unidos, Canadá
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Integra LifeSciences CorporationIntegriumRescindidoÚlceras do Pé DiabéticoEstados Unidos, Porto Rico, Canadá, África do Sul
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ULURU Inc.Navy Advanced Medical Development (NAMD) CommandAtivo, não recrutandoFerimentos e LesõesEstados Unidos
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Vanderbilt University Medical CenterConcluídoDoença do Refluxo Gastroesofágico (DRGE) | Doença de Refluxo Não Erosiva (NERD)Estados Unidos
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ConcluídoDispepsia Funcional | Doença do Refluxo Gastroesofágico (DRGE) | Esofagite Eosinofílica (EoE)Estados Unidos
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Memorial Sloan Kettering Cancer CenterAmerican Cancer Society, Inc.; Go2 Foundation for Lung CancerRecrutamento
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ULURU Inc.United States Department of DefenseRecrutamentoÚlcera por Pressão Estágio II | Úlcera por Pressão Estágio III | Úlcera por Pressão, Estágio IVEstados Unidos
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University of Southern CaliforniaRecrutamento
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Kettering Health NetworkConcluídoParede Abdominal Ferida Aberta | Ferida que não cicatrizaEstados Unidos
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Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos IIIAinda não está recrutandoDoenças cardiovasculares | Dislipidemias | Reação Adversa à Estatina | Miopatia FarmacogênicaEspanha