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Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema (LRT for DME)
The purpose of the study is to find out which is a better treatment for diabetic macular edema (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-vascular endothelial growth factor (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.
Details
| Lead sponsor | Jaeb Center for Health Research |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 691 |
| Start date | 2007-03 |
| Completion | 2014-02 |
Conditions
- Diabetic Retinopathy
- Diabetic Macular Edema
Interventions
- Triamcinolone Acetonide + laser
- Ranibizumab + laser
- Sham injection + laser
- Ranibizumab + deferred laser
Primary outcomes
- Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity — from baseline to 1 Year
Change in best correct visual acuity letter score from baseline to one year 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. - Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year — from baseline to 1 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. - Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline — from baseline to 1 Year
- Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema — from baseline to 1 Year
- Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score — from baseline to 1 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 0. - Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness — from baseline to 1 Year
Change in best correct visual acuity letter score from baseline to one year 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.
Countries
United States