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Nikolas JS London, Pin-wen Wang, Avanti Ghanekar, Zdenka Haskova; RVO cross trial comparison: six-month outcomes in anti-VEGF-treated patients with branch and central retinal vein occlusion. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4623.
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© ARVO (1962-2015); The Authors (2016-present)
To examine the 6-month vision and anatomic outcomes across 8 large clinical trials with ranibizumab (RBZ) or aflibercept (AFL) for the treatment of patients with branch RVO (BRVO) or central RVO (CRVO).
In this retrospective cross-trial analysis, study designs, primary endpoints, inclusion/exclusion criteria, baseline (BL) characteristics, and outcomes were compared across 8 large phase 3 and 4 studies: BRAVO, BRIGHTER, VIBRANT, and SHORE for patients with BRVO and CRUISE, CRYSTAL, COPERNICUS, GALILEO, and SHORE for patients with CRVO. Variations in BL patient population included the inclusion/exclusion of patients with brisk afferent pupillary defect and retinal nonperfusion/macular ischemia. In the anti-VEGF-containing treatment arms, patients received a minimum of 3 monthly doses of RBZ or AFL therapy before being switched to PRN dosing. Variations in study design, BL characteristics, and treatment protocols make cross-trial comparisons challenging. Vision and anatomic outcomes at month 6 in VEGF-treated patients are presented herein.
Across trials, BL differences included BL BCVA, BL retinal thickness, and the proportion of patients with retinal nonperfusion at BL. Regardless, anti-VEGF treatment with RBZ/AFL resulted in clinically significant vision improvement across all 8 trials. At month 6, BRVO RBZ-treated patients in BRAVO, BRIGHTER, and SHORE had mean BCVA gains from BL of +14.8–19.1 letters compared with +17.0 letters in AFL-treated patients in VIBRANT. At month 6, CRVO RBZ-treated patients in CRUISE, CRYSTAL, and SHORE had mean BCVA gains from BL of +12.1–17.1 letters compared with +17.3-18.0 letters in AFL-treated patients in COPERNICUS and GALILEO. Anti-VEGF treatment resulted in reductions in retinal thickness in all trials at 6 months. In BRVO patients, mean reductions were similar with RBZ (–211.1 to –345.2 μm) and AFL (–280.5 μm). Greater reductions in retinal thickness were observed in CRVO patients treated with RBZ (–305.5 to –452.3 μm) and AFL (–448.6 to –457.2 μm).
RBZ and AFL treatment resulted in clinically meaningful vision and anatomic improvements at 6 months across all 8 RVO trials examined regardless of BL differences or anti-VEGF drug. Although findings should be interpreted with caution given the limitations of cross-trial comparisons, improvements were similar in patients treated with RBZ and AFL.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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