Two doses of the drug caused substantial decreases in the foveal thickness compared with sham treatment. The safety profile of ranibizumab was the same as in previous clinical trials of ranibizumab, said Rishi P. Singh, MD, who highlighted the 6-month results of the phase III CRUISE study for the CRUISE Study Group. Dr. Singh, of the Cole Eye Institute, Cleveland Clinic, Cleveland, OH, was one of the lead trialists in the study.
The CRUISE study is a 12-month, randomized trial of ranibizumab that is ongoing at 95 centers in the United States. All patients had ME secondary to CRVO that involved the fovea that was diagnosed within 12 months before inclusion in the study, best-corrected visual acuity (BCVA) between 20/40 and 20/320, and central subfield thickness that exceeded 250 μm.
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.