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Sponsors and Collaborators: |
National Eye Institute (NEI) Allergan Genentech |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00444600 |
The purpose of the study is to find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-VEGF injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.
Condition | Intervention | Phase |
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Diabetic Retinopathy Diabetic Macular Edema |
Drug: Triamcinolone Acetonide + laser Drug: Ranibizumab + laser Drug: Sham injection + laser Drug: Ranibizumab + deferred laser |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema |
Enrollment: | 691 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Sham injection + laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
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2: Experimental |
Drug: Ranibizumab + laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
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3: Experimental |
Drug: Ranibizumab + deferred laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
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4: Experimental |
Drug: Triamcinolone Acetonide + laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria
To be eligible, the following inclusion criteria (1-5) must be met:
General Exclusion Criteria
A subject is not eligible if any of the following exclusion criteria are present:
Study Eye Inclusion Criteria
The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. A subject may have two study eyes only if both are eligible at the time of randomization.
Study Eye Exclusion Criteria
The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
Study Chair: | Michael J. Elman, M.D. | Elman Retina Group, PA |
Responsible Party: | Jaeb Center for Health Research (DRCR.net) ( Roy W. Beck, M.D., Ph.D., Director ) |
Study ID Numbers: | NEI-133 |
Study First Received: | March 6, 2007 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00444600 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Diabetic Retinopathy Diabetic Macular Edema Lucentis Ranibizumab |
Triamcinolone Laser photocoagulation Combination Therapy |
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Edema Bevacizumab Hormones Diabetic Angiopathies Triamcinolone hexacetonide Signs and Symptoms Macular Edema Triamcinolone Acetonide Triamcinolone |
Diabetes Complications Retinal Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Retinal Degeneration Macular Degeneration Endocrine System Diseases Triamcinolone diacetate Glucocorticoids Immunosuppressive Agents Diabetic Retinopathy Endocrinopathy |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Hormones Diabetic Angiopathies Triamcinolone hexacetonide Signs and Symptoms Macular Edema Triamcinolone Acetonide Therapeutic Uses Triamcinolone Cardiovascular Diseases |
Diabetes Complications Retinal Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Macular Degeneration Endocrine System Diseases Retinal Degeneration Enzyme Inhibitors Triamcinolone diacetate Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Diabetic Retinopathy |