drugset / Trial / NCT00336323
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
Phase 2
Completed
121 enrolled
Jaeb Center for Health Research
National Eye Institute (NEI) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.
Timeline
- Start
- 2006-06
- Primary completion
- 2006-11
- Completion
- 2008-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); Laser at Baseline vs 1.25 mg Injection at Baseline and at 6 Weeks; p = 0.009; Least squares regression NCT00336323 ↗
registry analysis (superiority or other test); Laser at Baseline vs 2.5 mg Injection at Baseline and 6 Weeks; p <0.001; Least squares regression NCT00336323 ↗
Publications
- Results Diabetic Retinopathy Clinical Research Network; Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology. 2007 Oct;114(10):1860-7. doi: 10.1016/j.ophtha.2007.05.062. Epub 2007 Aug 15.
- Results Scott IU, Bressler NM, Bressler SB, Browning DJ, Chan CK, Danis RP, Davis MD, Kollman C, Qin H; Diabetic Retinopathy Clinical Research Network Study Group. Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema. Retina. 2008 Jan;28(1):36-40. doi: 10.1097/IAE.0b013e31815e9385.
- Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |
| Subject | Bevacizumab | Monoclonal antibody | 2.5 mg | Intravitreal |