INTRAVITREAL BEVACIZUMAB (AVASTIN) FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (IBEPE STUDY)

Abstract

To evaluate the effect of intravitreal bevacizumab on area of fluorescein leakage from active new vessels (NVs) and on best-corrected visual acuity in patients with actively leaking NV associated with diabetic retinopathy unresponsive to panretinal photocoagulation. A prospective open-label study of diabetic patients with actively leaking NV refractory to panretinal photocoagulation and best-corrected visual acuity worse than 20/40. Ophthalmic evaluation, including fluorescein angiography, was performed at baseline and at Weeks 1, 6, 12, 24, and 48 after intravitreal bevacizumab (1.5 mg/0.06 mL) injection. After Week 12, patients could receive additional intravitreal bevacizumab injections pro re nata, per the discretion of the treating ophthalmologist. Main outcome measures include change from baseline (at each study visit) in total area of fluorescein leakage from active NV and change from baseline in best-corrected visual acuity. Fifteen consecutive patients were included, and 12 completed the study. Mean ± SEM fluorescein leakage was 27.7 ± 6.2 mm at baseline and was significantly lower at all visits post injection; at Week 6, no leakage was observed (P = 0.0001). The mean ± SEM logarithm of minimum angle of resolution best-corrected visual acuity improved from 0.90 ± 0.11 at baseline to 0.70 ± 0.12 at Week 48 (P = 0.0449). Throughout the 48-week study period, patients received a mean of 2.16 injections. With 1-year follow-up, treatment with intravitreal bevacizumab was associated with reduced fluorescein leakage from persistent NV and improved visual acuity in patients with diabetic retinopathy unresponsive to panretinal photocoagulation.