Topical Squalamine 0.2% and Intravitreal Ranibizumab 0.5 mg as Combination Therapy for Macular Edema Due to Branch and Central Retinal Vein Occlusion: An Open-Label, Randomized Study

BACKGROUND AND OBJECTIVE: To evaluate the effects of squalamine (OHR-102; Ohr Pharmaceuticals, New York, NY) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) on macular edema (ME) secondary to retinal vein occlusion (RVO). PATIENTS AND METHODS: Twenty consecutive, treatment-naive patients with RVO-related ME received topical squalamine and intravitreal ranibizumab 0.5 mg for 10 weeks, followed by randomization to continue or discontinue squalamine. Groups received as-needed ranibizumab from weeks 2 through 34. The primary endpoint was the proportion of eyes gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 38. Safety and tolerability were assessed. Data from 13 treatment-naive control eyes previously enrolled in three similar trials evaluating monthly ranibizumab 0.5 mg for RVO-related ME were included for comparison. RESULTS: At baseline, mean best-corrected visual acuity (BCVA) measures were 55.6 ETDRS letters and 55.0 ETDRS letters in the squalamine and control groups, respectively. At week 38, BCVA improved 25.6 letters in the squalamine group; at month 9, BCVA improved 16.3 letters in the control group. This corresponds to a between-treatment-group difference of 9.2 letters. Squalamine and ranibizumab combination therapy was well-tolerated. CONCLUSIONS: In patients with RVO-related ME, topical squalamine combined with early, as-needed ranibizumab appears to enhance visual recovery versus ranibizumab alone. Combination therapy appears safe and was well-tolerated.