Drug promising for central retinal vein occlusion

March 15, 2010

Ranibizumab for the treatment of macular edema associated with central retinal vein occlusion demonstrated rapid and sustained improvement as early as 7 days after the start of treatment through 6-month interim analysis.

Cleveland, OH-Ranibizumab (Lucentis, Genentech) for the treatment of macular edema (ME) associated with central retinal vein occlusion (CRVO) demonstrated rapid and sustained improvement as early as 7 days after the start of treatment through 6-month interim analysis.

Study design

Patients could have been treated with intraocular corticosteroids and anti-vascular endothelial growth factor (VEGF) therapy for ME up to 3 months before the start of the study. At study enrollment, 14% of patients had previous treatment, of which 7% had received anti-VEGF therapy before this study.

Patients were randomly assigned to sham treatment, the 0.3-, or the 0.5-mg dose of ranibizumab injected intravitreally for 6 months. All of the groups were well balanced demographically and with respect to baseline characteristics. After the 6-month endpoint, the study continued into an as-needed treatment period, during which all subjects could receive ranibizumab based on a central subfield thickness exceeding 250 μm or a decrease in BCVA to worse than 20/40.

The primary study endpoint was the mean change in BCVA compared with baseline. Investigators also calculated the number of patients who gained 15 letters or more of VA and those who lost more than 15 letters of VA at 6 months compared with the baseline value. The trial evaluated any ocular and non-ocular adverse events related to the treatment. In particular, the occurrence of arterial thromboembolic events was monitored using the Antiplatelet Trialists' Collaboration definition.