Intravitreal bevacizumab for choroidal neovascularization caused by AMD (IBeNA study): Results of a phase 1 dose-escalation study

PURPOSE. To evaluate the safety of three dose regimens of intravitreal bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA) for the management of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD). METHODS. This was a prospective, nonrandomized open-label study of 45 patients with AMD and subfoveal CNV. A standardized ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (± 1) after a single intravitreous injection (1.0. 1.5, or 2.0 mg) of bevacizumab. Main outcomes measures include clinical evidence of toxicity and complications. Changes in best corrected visual acuity (BCVA) and lesion characteristics-macular morphology were also evaluated. RESULTS. The most common adverse events were conjunctival hyperemia and subconjunctival hemorrhage at the injection site. Mean BCVA improved from baseline throughout the study (P < 0.001; ANOVA with Geisser-Greenhousce correction). Compared with baseline, BCVA was improved at week 1 (P = 0.001), week 6 (P < 0.001), and week 12 (P = 0.001; Dunnett test). At week 12, the lesion area and CNV area were stable or decreased in 79.1% (34/43) and in 74.4% (32/43) of patients, respectively, with no deterioration of macular architecture observed in 83.7% (36/43). A dose-related change in BCVA (in Early Treatment Diabetic Retinopathy Study [ETDRS] lines) was observed at week 12 (1.0 mg [+0.3 line]; 1.5 mg [+0.6 line]; and 2.0 mg [+1.0 line]; P = 0.02; nonparametric test for ordered groups). CONCLUSIONS. A single intravitreal bevacizumab injection was well tolerated and, except for minor transient local adverse events, no other adverse events were observed. In the short-term, treatment was associated with vision stabilization or improvement and no unfavorable neovascular lesion-macular changes in most patients.