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Peter A. Campochiaro, Linda Yau, Phillip Lai, Tatiana Beres; Safety and Efficacy Outcomes of Open-Label Ranibizumab in Retinal Vein Occlusion: HORIZON Extension Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):4869.
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Evaluate long-term safety and efficacy of ranibizumab (RBZ) in patients (pts) with macular edema (ME) following retinal vein occlusion (RVO).
HORIZON (HZN) (Cohort 2) was an open-label, single-arm, multicenter study, in which pts who completed the 12-month BRAVO and CRUISE trials could receive intravitreal RBZ 0.5 mg at ≥30-day intervals if they had central subfield thickness ≥250 µm or ME that affected visual acuity. Enrolled pts were followed for up to 24 months or until study termination (30 days after FDA approval of RBZ for RVO treatment). Efficacy outcomes included changes in best-corrected visual acuity (BCVA) and central foveal thickness (CFT) from HZN baseline (BL) to Month 12 (M12). Key ocular and nonocular safety events for the study duration (24-months or study termination) were summarized.
608 pts were enrolled in HZN Cohort 2 (304 initially enrolled in BRAVO, 304 initially enrolled in CRUISE). Of these, 205 (67%) BRAVO and 181 (60%) CRUISE pts completed M12 of HZN, receiving a mean of 2.5 and 3.8 injections of 0.5 mg RBZ, respectively, during those 12 months. BCVA remained stable in BRAVO pts over the first 12 months of HZN, with mean changes within ±2 letters of HZN BL. In CRUISE pts, BCVA declined, with mean reductions of 4-5 letters from HZN BL to M12. Mean CFT increases from HZN BL were minimal in BRAVO pts, and ranged from 68-88 µm in CRUISE pts at M12. The incidence of study eye serious adverse events (SAEs) and SAEs potentially related to systemic VEGF inhibition across treatment arms during the entire HZN trial was 2-9% and 1-6%, respectively.
Results for the first 12 months of HZN suggest that the PRN dosing criteria were adequate to maintain visual gains in those pts with branch RVO but may not have been sufficient for those pts with central RVO. No new safety events were identified.
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