Ranibizumab well tolerated by patients; results maintained better for branch occlusion
The HORIZON retinal vein occlusion (RVO) Study, an extension study of BRAVO, found that long-term (2-year) multiple intravitreal injections of ranibizumab (Lucentis, Genentech/Novartis) were well-tolerated by patients with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
The HORIZON RVO Study of 0.5 mg ranibizumab was composed of patients who completed treatment in the BRAVO Study for BRVO or the CRUISE study for CRVO. The BRAVO and CRUISE studies were 12-month trials; during the first 6 months of those trials, patients were randomized to either monthly sham treatment or 0.3 or 0.5 mg injections of ranibizumab, and during the second 6 months of the study, all patients could be treated with 0.5 mg monthly injections of the drug as needed. Patients in the BRAVO study were also eligible for rescue laser treatment, noted Dr Awh, who is in private practice in Nashville, Tennessee, USA.
During the HORIZON study, the patients who had been in the BRAVO Study received a mean of 2.5 injections of ranibizumab, with most receiving from 0 to 3 injections, and the patients who had been in the CRUISE Study received a mean of 3.8 injections, with most receiving from 1 to 6 injections of the drug through month 12.
"Relatively few injections were given during the 1-year HORIZON Study," Dr Awh said.
A substantial number of patients with BRVO, 67%, received at least one grid laser treatment during the BRAVO Study, with an additional 9% receiving laser during the HORIZON Study.
Dr Awh said that the safety results were consistent with previous phase III studies of ranibizumab. The results were also similar between the two study groups.
"During the HORIZON Study, in which patients received relatively few injections, the vision achieved in the BRAVO Study remained essentially stable," he said. "There was little change between the HORIZON baseline visual acuity data and the HORIZON 12-month visual acuity data. However, the patients with CRVO in the CRUISE Study were not able to maintain their visual acuity gains as well at the 12-month point in the HORIZON Study. At the end of the HORIZON Study, about 1 line of vision was lost in each CRVO patient group."
The findings on the OCT imaging paralleled the visual acuity changes in the groups. The OCT changes stayed relatively stable in the patients with BRVO; in patients with CRVO, OCT showed a moderate increase in the thickness of the central fovea, according to Dr Awh.