- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00445003
Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy (LRTforDME+PRP)
Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Study Overview
Status
Intervention / Treatment
Detailed Description
Proliferative diabetic retinopathy (PDR) is manifested in retinal neovascularization at the disc (NVD) or elsewhere (NVE). Vitreous hemorrhage or tractional detachment from PDR is a leading cause of severe visual loss and new onset blindness. Without intervention, 60 percent of individuals with diabetic retinopathy will eventually develop PDR, resulting in significant visual loss in nearly fifty percent.
Proliferative diabetic retinopathy is currently treated with panretinal photocoagulation (PRP) which destroys areas of the retina but preserves central vision. PRP is most effectively seen in a regression of new vessels, stabilization of the neovascularization, and reduced risk of visual loss. However, the treatment is associated with unavoidable side effects including macular edema with transient or permanent central vision loss, diminished vision loss, and night vision loss. The treatment applies laser burns to the peripheral retinal tissue, destroying outer photoreceptors and retinal pigment epithelium of the retina, and is thought to exert its effect by increasing oxygen delivery to the inner retina and decreasing viable hypoxic cells which are producing growth factors such as VEGF. Studies have implicated vascular endothelial growth factor (VEGF) as the substance leading to neovascularization and/or increased vascular permeability. Thus, it is reasonable to expect that inhibition of VEGF could reduce both PDR and transient vision loss from macular edema. There are several anti-VEGF drugs. Ranibizumab is the drug to be evaluated in this trial. In one trial of ranibizumab on DME, ten patients with chronic DME received a series of 0.5 mg intraocular injections. The treatments were well tolerated with no ocular or systemic adverse events. Since intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in all ten patients, there is strong rationale to consider this drug as adjunctive therapy to PRP in a attempt to reduce the acute, transient edema that may occur with PRP.
Similarly, corticosteroids, a class of substances with anti-inflammatory properties, have demonstrated to inhibit the expression of VEGF. Triamcinolone acetonide is often used as a periocular injection for the treatment of cystoid macular edema (CME) secondary to uveitis. Clinically, triamcinolone acetonide is used in the treatment of proliferative vitreoretinopathy and choroidal neovascularization. Studies on patients with proliferative diabetic retinopathy randomly assigned to receive 4 mg triamcinolone 10 to 15 days prior to PRP treatment showed a reduction in central macular thickening, and fluorescein leakage was greater in the injection group than in the control group at 9 and 12 months follow up. Mean visual acuity improved by one line in the injection group and worsened by two lines in the control group.
In summary, there is strong rationale that using either intravitreal ranibizumab or intravitreal triamcinolone acetonide as an adjunct to PRP could reduce the magnitude of vision loss.
This study is being conducted to determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the occurrence of macular edema and visual acuity impairment following PRP. Subjects will be randomly assigned with equal probability to one of the following three injection groups:
- Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and 4 weeks
- Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
- Sham injection at baseline and 4 weeks
The initial injection (or sham) is given on the day of randomization. Focal (macular) photocoagulation is given 7 to 10 days following the injection. Panretinal (scatter) photocoagulation can be initiated either on the same day as the focal photocoagulation (immediately following the focal photocoagulation) or on a subsequent day but must be initiated within 14 days of the baseline injection. Required follow-up visits occur at 4, 14, 34 and 56 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Artesia, California, United States, 90701
- Sall Research Medical Center
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Irvine, California, United States, 92697
- University of California, Irvine
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Loma Linda, California, United States, 92354
- Loma Linda University Health Care, Dept. of Ophthalmology
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Palm Springs, California, United States, 92262
- Southern California Desert Retina Consultants, MC
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Santa Barbara, California, United States, 93103
- California Retina Consultants
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Walnut Creek, California, United States, 94598
- Bay Area Retina Associates
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Colorado
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Louisville, Colorado, United States, 80027
- Eldorado Retina Associates, P.C.
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Florida
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Fort Myers, Florida, United States, 33912
- Retina Consultants of Southwest Florida
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Ft. Lauderdale, Florida, United States, 33334
- Retina Vitreous Consultants
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Lakeland, Florida, United States, 33805
- Central Florida Retina Institute
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Georgia
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Augusta, Georgia, United States, 30909
- Southeast Retina Center, P.C.
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago Medical Center
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Joliet, Illinois, United States, 60435
- Illinois Retina Associates
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Indiana
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Indianapolis, Indiana, United States, 46280
- Raj K. Maturi, M.D., P.C.
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New Albany, Indiana, United States, 47150
- John-Kenyon American Eye Institute
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Iowa
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Dubuque, Iowa, United States, 52002
- Medical Associates Clinic, P.C.
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Kentucky
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Paducah, Kentucky, United States, 42001
- Paducah Retinal Center
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Maine
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Bangor, Maine, United States, 04401
- Maine Vitreoretinal Consultants
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Maryland
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Baltimore, Maryland, United States, 21237
- Elman Retina Group, P.A.
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Baltimore, Maryland, United States, 21287-9277
- Wilmer Ophthalmological Institute at Johns Hopkins
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Salisbury, Maryland, United States, 21801
- Retina Consultants of Delmarva, P.A.
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Minneapolis, Minnesota, United States, 55404
- Retina Center, PA
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- Eyesight Ophthalmic Services, PA
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New York
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New York, New York, United States, 10003
- The New York Eye and Ear Infirmary/Faculty Eye Practice
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Syracuse, New York, United States, 13224
- Retina-Vitreous Surgeons of Central New York, PC
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7040
- University of North Carolina, Dept of Ophthalmology
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Charlotte, North Carolina, United States, 28210
- Charlotte Eye, Ear, Nose and Throat Assoc., PA
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Charlotte, North Carolina, United States, 28211
- Horizon Eye Care, PA
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Eye Center
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Dublin, Ohio, United States, 43017
- OSU Eye Physicians and Surgeons, LLC.
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Oregon
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Portland, Oregon, United States, 97239
- Casey Eye Institute
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Portland, Oregon, United States, 97210
- Retina Northwest, PC
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Scheie Eye Institute
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Retina Consultants
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South Carolina
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Columbia, South Carolina, United States, 29223
- Carolina Retina Center
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Columbia, South Carolina, United States, 29169
- Palmetto Retina Center
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Southeastern Retina Associates, PC
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Knoxville, Tennessee, United States, 37909
- Southeastern Retina Associates, P.C.
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Texas
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Abilene, Texas, United States, 79605
- West Texas Retina Consultants P.A.
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Arlington, Texas, United States, 76012
- Texas Retina Associates
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Austin, Texas, United States, 78705
- Retina Research Center
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Dallas, Texas, United States, 75231
- Texas Retina Associates
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Houston, Texas, United States, 77030
- Vitreoretinal Consultants
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Houston, Texas, United States, 77025
- Retina and Vitreous of Texas
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Lubbock, Texas, United States, 79424
- Texas Retina Associates
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McAllen, Texas, United States, 78503
- Valley Retina Institute
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San Antonio, Texas, United States, 78240
- Retinal Consultants of San Antonio
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Virginia
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Leesburg, Virginia, United States, 20176
- Virginia Retina Center
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion Criteria
- Age >= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Fellow eye (if not a study eye) meets criteria.
- Able and willing to provide informed consent. Study Eye Inclusion Criteria Subjects may have one or two study eyes. Subjects with two study eyes will be randomly assigned to receive sham injection at baseline and 4 weeks in one eye and either ranibizumab or triamcinolone in the other eye.
- Presence of severe nonproliferative or proliferative diabetic retinopathy for which investigator intends to complete panretinal photocoagulation within 49 days after randomization.
- Diabetic macular edema(DME) present on clinical exam and central subfield thickness on Optical Coherence Tomography (OCT) >250 microns, within 8 days of randomization.
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score >=24 (i.e., 20/320 or better), within 8 days of randomization.
- Media clarity, pupillary dilation, and subject cooperation sufficient to administer panretinal photocoagulation and obtain adequate fundus photographs and OCT.
- If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional focal photocoagulation.
General Exclusion Criteria
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drugs.
- Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-vascular endothelial growth factor(VEGF) or pro-VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.
Study Eye Exclusion Criteria, Study eye only:
- Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization.
- 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, preventing visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal 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., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, 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 treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- History of Yttrium Aluminum Garnet capsulotomy performed within 2 months prior to randomization.
- Aphakia.
- 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 criterion).
- History of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.
- History of prior herpetic ocular infection.
- Exam evidence of ocular toxoplasmosis.
- Exam evidence of pseudoexfoliation.
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
Fellow Eye Criteria
- 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 criterion).
- No history of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.
- No exam evidence of pseudoexfoliation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sham injection plus laser
Sham injection at baseline and 4 weeks.
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
|
Sham injection at baseline and 4 weeks
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
|
Experimental: 0.5mg Ranibizumab plus laser
Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks.
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
|
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks
Other Names:
|
Active Comparator: 4-mg Triamcinolone Acetonide plus Laser
4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks.
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
|
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
Time Frame: baseline to 14 weeks
|
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test.
Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
|
baseline to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional Treatments for Diabetic Macular Edema
Time Frame: 14 weeks to 56-weeks
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Each combination of treatment is only counted once per treatment eye.
Participants could have 2 study eyes, with random assignments to different treatments.
|
14 weeks to 56-weeks
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Change in Optical Coherence Tomography Central Subfield Thickness
Time Frame: Baseline to 14 weeks
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Baseline to 14 weeks
|
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Total Optical Coherence Tomography Retinal Volume
Time Frame: Baseline to 14-weeks
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Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39.
Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes.
Confidence intervals are adjusted for multiple comparisons.
|
Baseline to 14-weeks
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Change in Visual Acuity From Baseline
Time Frame: baseline to 56-weeks
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Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test.
Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
|
baseline to 56-weeks
|
Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
Time Frame: 14 weeks to 56-weeks
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14 weeks to 56-weeks
|
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Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
Time Frame: 14 weeks to 56-weeks
|
Treatments include any type or combination of treatment for diabetic macular edema.
Eyes were only counted once, when receiving a combination of treatments.
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14 weeks to 56-weeks
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Change in Optical Coherence Tomography Retinal Volume
Time Frame: Baseline to 14 weeks
|
Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively
|
Baseline to 14 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Joseph Googe, Jr., M.D., Southeastern Retina Associates, P.C.
Publications and helpful links
General Publications
- Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, Grover S, Miller DG; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013 Aug;131(8):1033-40. doi: 10.1001/jamaophthalmol.2013.4154.
- Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.
- Diabetic Retinopathy Clinical Research Network; Writing Committee; Aiello LP, Beck RW, Bressler NM, Browning DJ, Chalam KV, Davis M, Ferris FL 3rd, Glassman AR, Maturi RK, Stockdale CR, Topping TM. Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema. Ophthalmology. 2011 Dec;118(12):e5-14. doi: 10.1016/j.ophtha.2011.09.058.
- Glassman AR, Stockdale CR, Beck RW, Baker C, Bressler NM; Diabetic Retinopathy Clinical Research Network. Evaluation of masking study participants to intravitreal injections in a randomized clinical trial. Arch Ophthalmol. 2012 Feb;130(2):190-4. doi: 10.1001/archophthalmol.2011.387.
- Bressler SB, Qin H, Beck RW, Chalam KV, Kim JE, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch Ophthalmol. 2012 Sep;130(9):1153-61. doi: 10.1001/archophthalmol.2012.1107.
- Bressler SB, Almukhtar T, Aiello LP, Bressler NM, Ferris FL 3rd, Glassman AR, Greven CM; Diabetic Retinopathy Clinical Research Network. Green or yellow laser treatment for diabetic macular edema: exploratory assessment within the Diabetic Retinopathy Clinical Research Network. Retina. 2013 Nov-Dec;33(10):2080-8. doi: 10.1097/IAE.0b013e318295f744.
- Bressler SB, Almukhtar T, Bhorade A, Bressler NM, Glassman AR, Huang SS, Jampol LM, Kim JE, Melia M; Diabetic Retinopathy Clinical Research Network Investigators. Repeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment. JAMA Ophthalmol. 2015 May;133(5):589-97. doi: 10.1001/jamaophthalmol.2015.186.
- Bressler SB, Melia M, Glassman AR, Almukhtar T, Jampol LM, Shami M, Berger BB, Bressler NM; Diabetic Retinopathy Clinical Research Network. RANIBIZUMAB PLUS PROMPT OR DEFERRED LASER FOR DIABETIC MACULAR EDEMA IN EYES WITH VITRECTOMY BEFORE ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY. Retina. 2015 Dec;35(12):2516-28. doi: 10.1097/IAE.0000000000000617.
- Diabetic Retinopathy Clinical Research Network; Elman MJ, Qin H, Aiello LP, Beck RW, Bressler NM, Ferris FL 3rd, Glassman AR, Maturi RK, Melia M. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology. 2012 Nov;119(11):2312-8. doi: 10.1016/j.ophtha.2012.08.022. Epub 2012 Sep 19. Erratum In: Ophthalmology. 2014 Mar;121(3):805.
- Bressler SB, Glassman AR, Almukhtar T, Bressler NM, Ferris FL, Googe JM Jr, Gupta SK, Jampol LM, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema. Am J Ophthalmol. 2016 Apr;164:57-68. doi: 10.1016/j.ajo.2015.12.025. Epub 2016 Jan 21.
- Elman MJ, Ayala A, Bressler NM, Browning D, Flaxel CJ, Glassman AR, Jampol LM, Stone TW; Diabetic Retinopathy Clinical Research Network. Intravitreal Ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results. Ophthalmology. 2015 Feb;122(2):375-81. doi: 10.1016/j.ophtha.2014.08.047. Epub 2014 Oct 28.
- 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.
- Bhavsar AR, Googe JM Jr, Stockdale CR, Bressler NM, Brucker AJ, Elman MJ, Glassman AR; Diabetic Retinopathy Clinical Research Network. Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials. Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.
- Elman MJ, Bressler NM, Qin H, Beck RW, Ferris FL 3rd, Friedman SM, Glassman AR, Scott IU, Stockdale CR, Sun JK; Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):609-14. doi: 10.1016/j.ophtha.2010.12.033.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- NEI-134
- U10EY018817-03 (U.S. NIH Grant/Contract)
- U10EY014231-09 (U.S. NIH Grant/Contract)
- U10EY014229-07 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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