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W. Lloyd Clark, ; Two-Year Results of the COPERNICUS Study Evaluating Intravitreal Aflibercept Injection (IAI) for Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). Invest. Ophthalmol. Vis. Sci. 2013;54(15):4515.
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To evaluate the efficacy and safety of IAI for treatment of macular edema due to CRVO.
This double-masked, multicenter, 2-year, phase 3 trial randomized CRVO patients with macular edema to receive either IAI 2 mg (IAI 2q4) (n = 115) or sham (n = 74) injections every 4 weeks up to week 24. From week 24 to 52, all patients were evaluated monthly and received IAI pro re nata (PRN) (IAI 2q4-PRN and sham-IAI PRN). From week 52 to week 100, patients were evaluated quarterly to receive IAI PRN. If needed, patients could receive IAI as frequently as every 4 weeks. The primary efficacy endpoint was the proportion of patients who gained ≥ 15 letters at week 24.
The proportion of patients who gained ≥ 15 letters was 56.1% vs 12.3% (P < .001) at week 24, 55.3% vs 30.1% (P < .001) at week 52, and 49.1% vs 23.3% (P < .01) at week 100 in the IAI 2q4-PRN and sham-IAI PRN groups, respectively. The mean change from baseline visual acuity was +17.3 vs -4.0 letters (P < .001) at week 24, +16.2 vs +3.8 (P < .001) at week 52, and +13.0 vs +1.5 letters at week 100 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean reduction from baseline central retinal thickness was 457.2 vs 144.8 µm (P < .001) at week 24, 413.0 vs 381.8 µm at week 52, and 390.0 vs 343.3 µm at week 100 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean (SD) number of PRN IAI injections was 2.7 (1.7) vs 3.9 (2.0) from week 24 to 52 and 6.0 (3.4) vs 7.1 (3.4) from week 24 to 100 in the IAI 2q4-PRN and sham-IAI PRN groups, respectively. Over the 100 weeks, the most frequent ocular serious adverse events in the IAI 2q4-PRN and sham-IAI PRN groups were vitreous hemorrhage (0.9% vs 6.8%), glaucoma (0% vs 4.1%), and cataract (3.5% vs 1.4%). Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events occurred in 2 (1.8%) IAI2q4-PRN patients (nonfatal) from baseline to week100, and in 2 (2.7%) sham patients (fatal) from baseline to week 24.
The visual and anatomic improvements observed at the end of the fixed dosing period were diminished after changing to PRN dosing with a reduced monitoring frequency from week 52 to 100. IAI was generally well tolerated.
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