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The HORIZON Retinal Vein Occlusion Study, an extension study of the BRAVO Study, found that long-term multiple intravitreal injections of ranibizumab were well-tolerated by patients with branch retinal vein occlusion and central retinal vein occlusion.
Orlando, FL-The HORIZON Retinal Vein Occlusion (RVO) Study, an extension study of the BRAVO Study, found that long-term (2-year) multiple intravitreal injections of ran i biz u mab (Lucentis, Genen tech) were well-tolerated by patients with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
The study also demonstrated that patients with BRVO maintained both visual acuity and optical coherence tomography (OCT) improvements during the first year of the HORIZON trial, while patients with CRVO did not. Carl C. Awh, MD, presented the 12-month HORIZON RVO findings during Retina Subspecialty Day at the annual meeting of the American Academy of Ophthalmology.
During the HORIZON study, the patients who had been in the BRAVO Study received a mean of 2.5 injections of ran i biz u mab, 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 ran i biz u mab. 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.
"Long-term treatment of RVO with 0.5 mg ran i biz u mab during the HORIZON RVO Study was well tolerated, with no new safety events," he said. "The patients with BRVO maintained the improvements in vision and central foveal thickness during the HORIZON RVO Study, but the patients with CRVO did not. However, in the latter patients there was still an improvement from baseline, about 12 letters in the patients treated with 0.5 mg of ran i biz u mab."