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| Sponsor: | Diabetic Retinopathy Clinical Research Network |
|---|---|
| Collaborators: |
National Eye Institute (NEI) Genentech Allergan |
| Information provided by: | Diabetic Retinopathy Clinical Research Network |
| ClinicalTrials.gov Identifier: | NCT00445003 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Proliferative Diabetic Retinopathy Diabetic Macular Edema |
Drug: Ranibizumab Drug: Triamcinolone Acetonide Behavioral: Sham injection Procedure: Focal/grid laser |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy |
| Enrollment: | 333 |
| Study Start Date: | March 2007 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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.
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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.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
General Inclusion Criteria
General Exclusion Criteria
Study Eye Exclusion Criteria, Study eye only:
Fellow Eye Criteria
Contacts and Locations
Show 56 Study Locations| Study Chair: | Alexander J. Brucker, M.D. | Scheie Eye Institute |
| Study Chair: | Joseph Googe, Jr., M.D. | Southeastern Retina Associates, P.C. |
More Information
| Responsible Party: | Adam R. Glassman, MS, DRCR.net Director, Jaeb Center for Health Research (DRCR.net) |
| ClinicalTrials.gov Identifier: | NCT00445003 History of Changes |
| Other Study ID Numbers: | NEI-134, U10EY018817-03, U10EY014229-07, U10EY014231-09 |
| Study First Received: | March 6, 2007 |
| Results First Received: | April 14, 2011 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Diabetic Retinopathy Diabetic Macular Edema Lucentis Ranibizumab |
Triamcinolone Panretinal Photocoagulation Combination Therapy pdr |
|
Diabetic Retinopathy Edema Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration Triamcinolone hexacetonide |
Triamcinolone Acetonide Triamcinolone Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |