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David Brown, Frank Holz, COPERNICUS and GALILEO study investigators; Treatment Experience with Intravitreal Aflibercept Injection (IAI) After Switching to PRN Dosing in Patients with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). Invest. Ophthalmol. Vis. Sci. 2013;54(15):4514.
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The 52-week results of COPERNICUS and GALILEO studies demonstrated that visual and anatomical improvements after six monthly IAI at week 24 were largely maintained at week 52 following switching to PRN dosing. This analysis evaluated the treatment experience between weeks 24 and 52.
Two double-masked, multicenter, phase 3 trials (COPERNICUS and GALILEO) randomized patients to receive either IAI 2 mg or sham every 4 weeks up to week 24. In COPERNICUS, all patients received IAI pro re nata (PRN) from week 24 to week 52. In GALILEO, the IAI group received IAI PRN from week 24 through week 52, and the sham group continued to receive monthly sham injections through week 52. Treatment experience was evaluated in patients who received IAI from baseline.
In COPERNICUS, IAI patients (n = 110) received a mean (SD) of 2.7 ± 1.7 injections (range: 0-7) from week 24 to 52. Percentages of patients who had ≤ 3 and ≥ 4 injections were 70.9% and 29.1% respectively. Thirty-two patients (29.1%) received IAI at week 24 and had a mean (SD) of 4.1 ± 1.6 injections (range: 1-7) from week 24 to 52 while 78 patients (70.9%) did not require IAI at week 24 and had a mean (SD) of 2.1 ± 1.3 injections (range: 0-6) from week 24 to 52. In GALILEO, IAI patients (n = 97) received a mean (SD) of 2.5 ± 1.7 injections (range: 0-6) from week 24 to 52. Percentages of patients who had ≤ 3 or ≥ 4 injections were 72.2% and 27.8%, respectively. Nineteen patients (19.6%) received IAI at week 24 and had a mean (SD) of 3.8 ± 1.8 injections (range: 1-6) from week 24 to 52 while 78 patients (80.4%) did not require IAI at week 24 and had a mean (SD) of 2.1 ± 1.6 injections (range: 0-6) from week 24 to 52. The most frequent ocular serious adverse events were macular edema and vitreous hemorrhage.
Across both studies, over 70% of patients received ≤ 3 injections during PRN dosing. Most patients (> 70%) did not receive IAI at week 24. Patients who did not receive IAI at week 24 had fewer injections during PRN dosing than those who received IAI at week 24.
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