Ranibizumab for Macular Edema Due to Retinal Vein Occlusions; Two Year Outcomes

Abstract

Purpose: : To determine the long term effects of intraocular ranibizumab in patients with macular edema due to retinal vein occlusions (RVOs).

Methods: : The primary endpoint (3 months) results of intraocular injections of 0.3 or 0.5 mg of ranibizumab in patients with macular edema due to central RVO (CRVO; n=20) or branch RVO (BRVO; n=20) have been previously reported. After 3 months, patients were given ranibizumab injections as needed for recurrent edema and visual and anatomic outcomes at 2 years are reported.

Results: : For 17 patients with BRVO who completed 2 years of follow up, the mean improvement in BCVA at Month 24 was 17.8 letters compared to 15.6 letters at the Month 3 primary endpoint. Three patients (18%) improved by 6 or more lines, 10 (59%) by 3 or more lines, and 13 (76%) by 2 or more lines. The Snellen equivalent BCVA at Month 24 was 20/40 or better in 10 patients, 20/60 or better in 14, 20/80 or better in 16, and 20/100 in one patient. Edema was well controlled with an average of 2.5 injections of ranibizumab during year 2; mean center subfield thickness (foveal thickness, FTH) at Month 24 was 245.8 µm compared to 217.1 µm at Month 3 and 481.5 µm at baseline. For 14 patients with CRVO who completed 2 years of follow up, the mean improvement in BCVA at Month 24 was 9.1 letters compared to 11 letters at Month 3. There was improvement of 6 or more lines in 2 (14.3%), 3 or more lines in 3 (21.4%), and 2 or more lines in 6 (42.9%), and 9 patients (64.3%) gained at least one line. Three patients had essentially no change from baseline (+3, +1, -2) and 2 patients lost vision (-7 and -20 letters). The Snellen equivalent BCVA at Month 24 was 20/40 or better in 4 patients, 20/60 or better in 7, 20/80 or better in 8, better than 20/200 in 11, and worse than 20/200 in 2. With an average of 4 injections in year 2, mean FTH at Month 24 was 338 µm compared to 300 µm at Month 3 and 533 µm at baseline. Duration of RVO ≥ 1 year at study entry and nonperfusion of perifoveal capillaries for 360 degrees correlated with reduced visual outcomes.

Conclusions: : Ranibizumab provides substantial long term benefit to patients with macular edema due to RVO, but frequent injections are required in some patients with BRVO and most patients with CRVO.

Clinical Trial: : www.clinicaltrials.gov NCT00407355

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • hypoxia • edema