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E. P. Jablon, V. D. Alfaro, J. B. Kerrison, M. Rodriguez-Fontal, R. Garcia, F. Gomez-Ulla; Study of Ranibizumab Treatment for Branch Retinal Vein Occlusion-Associated Cystoid Macular Edema. Invest. Ophthalmol. Vis. Sci. 2007;48(13):317.
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Ranibizumab (LucentisTM) is a humanized antigen-binding antibody fragment (Fab) that inhibits all isoforms of vascular endothelial growth factor-A and its biologically active degradation products. This study compares the safety and efficacy of monthly intravitreal (ITV) injections of ranibizumab in patients with cystoid macular edema (CME) associated with branch retinal vein occlusion (BRVO).
A total of 7 of the expected 20 patients are currently enrolled in this study and received 3 monthly ITV injections of either 0.3 mg or 0.5 mg ranibizumab in this single-center, open-label trial. Re-treatment with ranibizumab was at the discretion of the physician during the remainder of the study. The primary efficacy endpoint was the percentage of patients who gained at least 15 letters of best-corrected ETDRS visual acuity (BCVA) from baseline to 1 year. The secondary endpoints included the change in BCVA from baseline to each assessment visit, 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.
After 3 months of follow-up, ranibizumab resulted in stable vision (a loss of <15 letters) in 100% of patients. There was a mean improvement in BCVA at 2 meters of 17.5 letters compared with baseline, and 57% (4/7) of patients gained at least 15 letters of BCVA at 2 meters. Central retinal thickness decreased by a mean of 86.8 µm compared with baseline. Thus far, no serious ocular or systemic adverse events have been reported.
Ranibizumab is well tolerated and at least stabilizes, if it does not improve, vision and decreases central retinal thickness in patients with BRVO-associated CME.
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