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

25. august 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

840

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andre navne:
  • soc with laser
  • modified ETDRS photocoagulation
Eksperimentel: 2
Intravitreal injection of 1mg of triamcinolone acetonide
Medicin: 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.
Andre navne:
  • kortikosteroid
Eksperimentel: 3
Intravitreal injection of 4mg of triamcinolone acetonide
Medicin: 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.
Andre navne:
  • kortikosteroid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Central Subfield Thickness at 2 Years
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jaeb Center for Health Research

Samarbejdspartnere

National Eye Institute (NEI)
Allergan

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2004

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

3. august 2006

Først indsendt, der opfyldte QC-kriterier

18. august 2006

Først opslået (Skøn)

22. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NEI-105
  • U10EY018817-03 (U.S. NIH-bevilling/kontrakt)
  • U10EY014231-09 (U.S. NIH-bevilling/kontrakt)
  • U10EY014229-07 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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