|
|
|
Pegaptanib in Diabetic Retinopathy: Improvements in Diabetic Macular Edema, Retinal Neovascularization, and Diabetic Retinopathy Severity
Diabetic Retinopathy Highlights from Retina/Vitreous Free Papers
| Sunday, November 12, 2006 |
| Victor H Gonzalez, MD, Macugen Diabetic Retinopathy Study Group
Pegaptanib is currently FDA-approved for the treatment of age-related macular degeneration (AMD). It is now in clinical trials for diabetic retinopathy (DR) indications. The safety and efficacy of pegaptanib was evaluated in a Phase 2 trial of 172 patients with DR or diabetic macular edema (DME) randomized to receive either 0 mg (sham), 0.3 mg, 1 mg, or 3 mg pegaptanib via intravitreal injection every 6 weeks for 30 weeks with 82 weeks’ follow up.
Patients treated with 0.3 mg pegaptanib experienced statistically significant improvements in all endpoints at 30 weeks, including an average 4.7 letter gain in visual acuity, decreased retinal thickness, and decreased need for laser photocoagulation. In a subset of 13 eyes with neovascularization treated with pegaptanib, 8 showed regression and/or reduced leakage; none of 7 fellow eyes or eyes receiving sham treatment showed regression. Pegaptanib was well tolerated, and appears to be safe and effective in treating eyes with DR/DME.
Dr Haller would have liked further explanation of how the fellow eyes were treated. Dr Bressler commented that he would like to see how these results would compare with a similar patient population treated with ranibizumab. |
|
|
