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V. D. Alfaro, III, E. P. Jablon, J. B. Kerrison, M. Rodriguez-Fontal, F. Gomez-Ulla, R. Bueno; Ranibizumab for the Treatment of Branch Retinal Vein Occlusion-Associated Cystoid Macular Edema. Invest. Ophthalmol. Vis. Sci. 2008;49(13):2699.
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Ranibizumab (Lucentis®) is a humanized antigen-binding antibody fragment (Fab) that binds and inhibits all vascular endothelial growth factor-A isoforms and their biologically active degradation products. This study evaluates the safety and efficacy of monthly intravitreal injections of ranibizumab in patients with cystoid macular edema (CME) associated with branch retinal vein occlusion (BRVO).
This is a single-center, open-label, 12-month study where patients receive 3 monthly intravitreal injections of either 0.3 mg or 0.5 mg ranibizumab. Eleven patients (out of 20 patients expected) are currently enrolled in this study. Re-treatment with ranibizumab is at the physician’s discretion after the initial 3 injections. The primary efficacy endpoint is the percentage of patients who gained ≥15 letters of best-corrected ETDRS visual acuity (BCVA) at a starting distance of 2 or 4 meters from baseline to 12 months. The secondary endpoints include the change in BCVA from baseline and the change in retinal thickness at each assessment visit as measured by optical coherence tomography and fundus photography, and the incidence and severity of adverse events.
The first 11 patients received a mean of 7 intravitreal injections (9 patients have completed 12 months and 2 have completed 10 months of the study). After 6 months, ranibizumab treatment resulted in stable vision (a loss of <15 letters) in 100% (11/11) of patients. Mean gain in BCVA at a starting distance of 2 meters was 15.5 ± 14.7 letters compared with baseline, and 55% (6/11) of patients gained ≥15 letters. Central retinal thickness decreased by a mean of 164.4 ± 167.3 µm compared with baseline. The 6-month results were sustained through 12 months (9/11 patients have completed 12 months), with a mean gain in BCVA of 16.2 ± 11.4 letters and a mean decrease in central retinal thickness of 167.9 ± 244.7 µm compared with baseline. Thus far, no serious ocular or systemic adverse events have been reported.
Ranibizumab is generally well tolerated and may stabilize or improve vision and decrease central retinal thickness in patients with BRVO-associated CME.
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