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Yuichiro Ogura, Jean-Francois Korobelnik, Johann Roider, Robert Vitti, Frank Holz, Florian Hiemeyer, Brigitte Stemper, Oliver Zeitz, Rupert Sandbrink, GALILEO study investigators; Eighteen-Month Results of the GALILEO Study Evaluating Intravitreal Aflibercept Injection (IAI) for Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). Invest. Ophthalmol. Vis. Sci. 2013;54(15):4516.
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To evaluate the efficacy and safety of IAI for treatment of macular edema due to central retinal vein occlusion (CRVO).
This double-masked, multicenter, 18-month, phase 3 trial randomized patients to receive either IAI 2 mg (IAI 2q4) (n=106) or sham (n=71) injections every 4 weeks up to Week 24. From Week 24 to 52, IAI patients were evaluated monthly and received IAI pro re nata (PRN) (IAI 2q4-PRN), and sham patients continued to receive monthly sham injections. From Week 52 to Week 76, all patients were evaluated every 8 weeks and received IAI PRN (IAI 2q4-PRN and sham-IAI PRN). 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 60.2% vs 22.1% at Week 24 (P<0.0001), 60.2% vs 32.4% (P=0.0004) at Week 52, and 57.3% vs 29.4% at Week 76 (P<0.01) in the IAI 2q4-PRN and sham-IAI PRN groups, respectively. The mean increase from baseline visual acuity was 18.0 vs 3.3 letters (P<0.0001) at Week 24, 16.9 vs 3.8 letters (P<0.0001) at Week 52, and 13.7 vs 6.2 letters at Week 76 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean reduction from baseline central retinal thickness was 448.6 vs 169.3 µm (P<0.0001) at Week 24, 423.5 vs 219.3 µm (P<0.0001) at Week 52, and 389.4 vs 306.4 µm at Week 76 in the IAI 2q4-PRN and sham-IAI PRN groups. The mean (SD) number of PRN IAI injections was 2.5 (1.7) in the IAI 2q4-PRN group from Weeks 24 to 52, and 1.3 (1.1) vs 1.7 (1.1) injections in the IAI 2q4-PRN and sham-IAI PRN groups, respectively, from Weeks 52 to 76. Over the 76 weeks, the most frequent ocular serious adverse events in the IAI 2q4-PRN and sham-IAI PRN groups were macular edema (3.8% vs 2.9%), glaucoma (0% vs 2.9%), reduced visual acuity (1.9% vs 1.5%), and vitreous hemorrhage (1.0% vs 1.5%). No Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events occurred during the study.
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 76. IAI was generally well tolerated.
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