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Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy (LRTforDME+PRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00445003
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : July 13, 2011
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
National Eye Institute (NEI)
Genentech, Inc.
Allergan
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Diabetic Macular Edema Drug: Ranibizumab Drug: Triamcinolone Acetonide Behavioral: Sham injection Procedure: Focal/grid laser Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : July 2010


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.
Behavioral: Sham injection
Sham injection at baseline and 4 weeks

Procedure: Focal/grid laser
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.
Drug: Ranibizumab
Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks
Other Name: Lucentis™

Procedure: Focal/grid laser
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.

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.
Drug: Triamcinolone Acetonide
Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
Other Name: corticosteroid

Procedure: Focal/grid laser
Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Additional Treatments for Diabetic Macular Edema [ Time Frame: 14 weeks to 56-weeks ]
    Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.

  2. Change in Optical Coherence Tomography Central Subfield Thickness [ Time Frame: Baseline to 14 weeks ]
  3. Total Optical Coherence Tomography Retinal Volume [ Time Frame: Baseline to 14-weeks ]
    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.

  4. Change in Visual Acuity From Baseline [ Time Frame: baseline to 56-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.

  5. Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema [ Time Frame: 14 weeks to 56-weeks ]
  6. 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.

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445003


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Locations
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United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
University of California, Irvine
Irvine, California, United States, 92697
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States, 92354
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
California Retina Consultants
Santa Barbara, California, United States, 93103
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Colorado
Eldorado Retina Associates, P.C.
Louisville, Colorado, United States, 80027
United States, Florida
Retina Consultants of Southwest Florida
Fort Myers, Florida, United States, 33912
Retina Vitreous Consultants
Ft. Lauderdale, Florida, United States, 33334
Central Florida Retina Institute
Lakeland, Florida, United States, 33805
United States, Georgia
Southeast Retina Center, P.C.
Augusta, Georgia, United States, 30909
United States, Illinois
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612
Illinois Retina Associates
Joliet, Illinois, United States, 60435
United States, Indiana
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States, 46280
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
United States, Iowa
Medical Associates Clinic, P.C.
Dubuque, Iowa, United States, 52002
United States, Kentucky
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
United States, Maine
Maine Vitreoretinal Consultants
Bangor, Maine, United States, 04401
United States, Maryland
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
Wilmer Ophthalmological Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287-9277
Retina Consultants of Delmarva, P.A.
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Retina Center, PA
Minneapolis, Minnesota, United States, 55404
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, United States, 03801
United States, New York
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York, United States, 10003
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, United States, 13224
United States, North Carolina
University of North Carolina, Dept of Ophthalmology
Chapel Hill, North Carolina, United States, 27599-7040
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, United States, 28210
Horizon Eye Care, PA
Charlotte, North Carolina, United States, 28211
Wake Forest University Eye Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
OSU Eye Physicians and Surgeons, LLC.
Dublin, Ohio, United States, 43017
United States, Oregon
Retina Northwest, PC
Portland, Oregon, United States, 97210
Casey Eye Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Retina Consultants
Providence, Rhode Island, United States, 02903
United States, South Carolina
Palmetto Retina Center
Columbia, South Carolina, United States, 29169
Carolina Retina Center
Columbia, South Carolina, United States, 29223
United States, Tennessee
Southeastern Retina Associates, PC
Kingsport, Tennessee, United States, 37660
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37909
United States, Texas
West Texas Retina Consultants P.A.
Abilene, Texas, United States, 79605
Texas Retina Associates
Arlington, Texas, United States, 76012
Retina Research Center
Austin, Texas, United States, 78705
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina and Vitreous of Texas
Houston, Texas, United States, 77025
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Texas Retina Associates
Lubbock, Texas, United States, 79424
Valley Retina Institute
McAllen, Texas, United States, 78503
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
United States, Virginia
Virginia Retina Center
Leesburg, Virginia, United States, 20176
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Jaeb Center for Health Research
National Eye Institute (NEI)
Genentech, Inc.
Allergan
Investigators
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Study Chair: Alexander J. Brucker, M.D. Scheie Eye Institute
Study Chair: Joseph Googe, Jr., M.D. Southeastern Retina Associates, P.C.

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00445003     History of Changes
Other Study ID Numbers: NEI-134
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2007    Key Record Dates
Results First Posted: July 13, 2011
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Jaeb Center for Health Research:
Diabetic Retinopathy
Diabetic Macular Edema
Lucentis
Ranibizumab
Triamcinolone
Panretinal Photocoagulation
Combination Therapy
pdr

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors