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Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (IVT)

25 augustus 2016 bijgewerkt door: Jaeb Center for Health Research

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:

  1. Laser photocoagulation
  2. 1mg intravitreal triamcinolone acetonide injection
  3. 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

840

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205-7199
        • Jones Eye Institute/University of Arkansas for Medical Sciences
    • California
      • Baldwin Park, California, Verenigde Staten, 91706
        • SCPMG Regional Offices - Kaiser Permanente
      • Beverly Hills, California, Verenigde Staten, 90211
        • Retina-Vitreous Associates Medical Group
      • Irvine, California, Verenigde Staten, 92697
        • University of California, Irvine
      • Loma Linda, California, Verenigde Staten, 92354
        • Loma Linda University Health Care, Dept. of Ophthalmology
      • Los Angeles, California, Verenigde Staten, 90033
        • Doheny Eye Institute
      • Los Angeles, California, Verenigde Staten, 90095
        • Jules Stein Eye Institute
      • Palm Springs, California, Verenigde Staten, 92262
        • Southern California Desert Retina Consultants, MC
      • San Francisco, California, Verenigde Staten, 94107
        • West Coast Retina Medical Group, Inc.
      • Santa Ana, California, Verenigde Staten, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, Verenigde Staten, 93103
        • California Retina Consultants
      • Walnut Creek, California, Verenigde Staten, 94598
        • Bay Area Retina Associates
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80204
        • Denver Health Medical Center
      • Louisville, Colorado, Verenigde Staten, 80027
        • Eldorado Retina Associates, P.C.
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06519-1600
        • Connecticut Retina Consultants
      • New Haven, Connecticut, Verenigde Staten, 06519
        • Connecticut Retina Consultants
    • Florida
      • Fort Myers, Florida, Verenigde Staten, 33912
        • National Ophthalmic Research Institute
      • Ft. Lauderdale, Florida, Verenigde Staten, 33334
        • Retina Group of Florida
      • Lakeland, Florida, Verenigde Staten, 33805
        • Central Florida Retina Institute
      • Lakeland, Florida, Verenigde Staten, 33805
        • Florida Retina Consultants
      • Sarasota, Florida, Verenigde Staten, 34239
        • Sarasota Retina Institute
      • Tampa, Florida, Verenigde Staten, 33603
        • International Eye Center
    • Georgia
      • Augusta, Georgia, Verenigde Staten, 30909
        • Southeast Retina Center, P.C.
    • Hawaii
      • Aiea, Hawaii, Verenigde Staten, 96701
        • Retina Consultants of Hawaii, Inc.
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Retina Associates of Hawaii, Inc.
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Verenigde Staten, 60611
        • Northwestern Medical Faculty Foundation
      • Joliet, Illinois, Verenigde Staten, 60435
        • Illinois Retina Associates
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46290
        • Raj K. Maturi, M.D., P.C.
      • New Albany, Indiana, Verenigde Staten, 47150
        • John-Kenyon American Eye Institute
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40509-1802
        • Retina and Vitreous Associates of Kentucky
      • Paducah, Kentucky, Verenigde Staten, 42001
        • Paducah Retinal Center
    • Maine
      • Bangor, Maine, Verenigde Staten, 04401
        • Maine Vitreoretinal Consultants
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21237
        • Elman Retina Group, P.A.
      • Baltimore, Maryland, Verenigde Staten, 21287-9277
        • Wilmer Ophthalmological Institute at Johns Hopkins
      • Greenbelt, Maryland, Verenigde Staten, 20770-3502
        • The Retina Group of Washington
      • Salisbury, Maryland, Verenigde Staten, 21801
        • Retina Consultants of Delmarva, P.A.
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Joslin Diabetes Center
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Ophthalmic Consultants of Boston
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
      • Detroit, Michigan, Verenigde Staten, 48201-1423
        • Kresge Eye Institute
      • Grand Rapids, Michigan, Verenigde Staten, 49546
        • Associated Retinal Consultants
      • Royal Oak, Michigan, Verenigde Staten, 48073
        • Vision Research Foundation
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55404
        • Retina Center, PA
    • Missouri
      • St. Louis, Missouri, Verenigde Staten, 63110
        • Barnes Retina Institute
      • St. Louis, Missouri, Verenigde Staten, 63104
        • St. Louis University Eye Institute
    • New Jersey
      • Lawrenceville, New Jersey, Verenigde Staten, 08648
        • Delaware Valley Retina Associates
    • New York
      • New York, New York, Verenigde Staten, 10003
        • The New York Eye and Ear Infirmary/Faculty Eye Practice
      • Rochester, New York, Verenigde Staten, 14642
        • University of Rochester
      • Slingerlands, New York, Verenigde Staten, 12159
        • Retina Consultants, PLLC
      • Syracuse, New York, Verenigde Staten, 13224
        • Retina-Vitreous Surgeons of Central New York, PC
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • University of North Carolina, Dept. of Ophthalmology
      • Charlotte, North Carolina, Verenigde Staten, 28210
        • Charlotte Eye Ear Nose and Throat Assoc, PA
      • Charlotte, North Carolina, Verenigde Staten, 28211
        • Horizon Eye Care, PA
      • Winston-Salem, North Carolina, Verenigde Staten, 27157
        • Wake Forest University Eye Center
    • Ohio
      • Beachwood, Ohio, Verenigde Staten, 44122
        • Retina Associates of Cleveland, Inc.
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Western Reserve University
      • Dublin, Ohio, Verenigde Staten, 43017
        • OSU Eye Physicians and Surgeons, LLC.
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Dean A. McGee Eye Institute
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Casey Eye Institute
      • Portland, Oregon, Verenigde Staten, 97210
        • Retina Northwest, PC
    • Pennsylvania
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Penn State College of Medicine
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania Scheie Eye Institute
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02903
        • Retina Consultants
    • South Carolina
      • Columbia, South Carolina, Verenigde Staten, 29223
        • Carolina Retina Center
      • Columbia, South Carolina, Verenigde Staten, 29169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, Verenigde Staten, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten, 37909
        • Southeastern Retina Associates, P.C.
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Abilene, Texas, Verenigde Staten, 79605
        • West Texas Retina Consultants P.A.
      • Arlington, Texas, Verenigde Staten, 76012
        • Texas Retina Associates
      • Austin, Texas, Verenigde Staten, 78705
        • Retina Research Center
      • Dallas, Texas, Verenigde Staten, 75231
        • Texas Retina Associates
      • Galveston, Texas, Verenigde Staten, 77555-1106
        • University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences
      • Houston, Texas, Verenigde Staten, 77030
        • Retina Consultants of Houston, PA
      • Houston, Texas, Verenigde Staten, 77025
        • Retina and Vitreous of Texas
      • Houston, Texas, Verenigde Staten, 77002
        • Charles A. Garcia, PA & Associates
      • Lubbock, Texas, Verenigde Staten, 79424
        • Texas Retina Associates
      • McAllen, Texas, Verenigde Staten, 78503
        • Valley Retina Institute
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84107
        • Rocky Mountain Retina Consultants
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53705
        • University of Wisconsin-Madison, Dept. of Ophthalmology
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Medical College of Wiconsin

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

To be eligible, the following inclusion criteria must be met:

  1. Age ≥18 years
  2. Diagnosis of diabetes mellitus (type 1 or type 2)
  3. Able and willing to provide informed consent.
  4. 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

  1. 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).
  2. Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
  3. Mean retinal thickness on two Optical Coherence Tomography (OCT) measurements ≥250 microns in the central subfield.

  4. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.

    Exclusion

  5. Macular edema is considered to be due to a cause other than diabetic macular edema.
  6. 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).
  7. 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.)
  8. 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).
  9. History of prior treatment with intravitreal corticosteroids.
  10. History of peribulbar steroid injection within 6 months prior to randomization.
  11. 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.
  12. History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization.
  13. Anticipated need for PRP in the 4 months following randomization.
  14. History of prior pars plana vitrectomy.
  15. 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.
  16. History of YAG capsulotomy performed within 2 months prior to randomization.
  17. Intraocular pressure ≥25 mmHg.
  18. 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.
  19. History of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
  20. History of prior herpetic ocular infection.
  21. Exam evidence of ocular toxoplasmosis.
  22. Aphakia.
  23. Exam evidence of pseudoexfoliation.
  24. 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:

  1. Best corrected e-ETDRS visual acuity score ≥19 letters (i.e., 20/400 or better).
  2. No prior treatment with intravitreal corticosteroids.
  3. Intraocular pressure < 25 mmHg.
  4. 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.
  5. No history of steroid-induced intraocular pressure elevation that required IOP-lowering treatment.
  6. No exam evidence of pseudoexfoliation.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Procedure: Standard of Care Group
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
Andere namen:
  • soc with laser
  • modified ETDRS photocoagulation
Experimenteel: 2
Intravitreal injection of 1mg of triamcinolone acetonide
Geneesmiddel: 1mg triamcinolone acetonide
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.
Andere namen:
  • corticosteroïde
Experimenteel: 3
Intravitreal injection of 4mg of triamcinolone acetonide
Geneesmiddel: 4mg triamcinolone acetonide
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.
Andere namen:
  • corticosteroïde

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Tijdsspanne: 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
Median Change in Visual Acuity Baseline to 2 Years
Tijdsspanne: 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
Distribution of Change in Visual Acuity Baseline to 2 Years
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Central Subfield Thickness at 2 Years
Tijdsspanne: 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
Mean Change in Central Subfield Thickness Baseline to 2 Years
Tijdsspanne: 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
Tijdsspanne: 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
Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Tijdsspanne: 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
Central Subfield Thickness < 250 Microns at 2 Years
Tijdsspanne: 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
Change in Visual Acuity From Baseline to 3 Years
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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Sponsor

Jaeb Center for Health Research

Medewerkers

National Eye Institute (NEI)
Allergan

Onderzoekers

  • Studie stoel: Michael Ip, M.D., University of Wisconsin Medical School

Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2004

Primaire voltooiing (Werkelijk)

1 mei 2008

Studie voltooiing (Werkelijk)

1 oktober 2008

Studieregistratiedata

Eerst ingediend

3 augustus 2006

Eerst ingediend dat voldeed aan de QC-criteria

18 augustus 2006

Eerst geplaatst (Schatting)

22 augustus 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

26 augustus 2016

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2016

Laatst geverifieerd

1 augustus 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NEI-105
  • U10EY018817-03 (Subsidie/contract van de Amerikaanse NIH)
  • U10EY014231-09 (Subsidie/contract van de Amerikaanse NIH)
  • U10EY014229-07 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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