TY - JOUR
T1 - Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion
T2 - Two-year results from the COPERNICUS study
AU - Heier, Jeffrey S.
AU - Clark, W. Lloyd
AU - Boyer, David S.
AU - Brown, David M.
AU - Vitti, Robert
AU - Berliner, Alyson J.
AU - Kazmi, Husain
AU - Ma, Yu
AU - Stemper, Brigitte
AU - Zeitz, Oliver
AU - Sandbrink, Rupert
AU - Haller, Julia A.
N1 - Funding Information:
Financial Disclosure(s): The author(s) have made the following disclosure(s): J.S.H. is a consultant to Acucela, Aerpio, Alimera, Allergan, Bausch & Lomb, Bayer, Dutch Ophthalmic, Endo Optiks, Forsight, Genzyme, Heidelberg Engineering, Kala Pharmaceuticals, Kanghong, LPath, Nicox, Notal Vision, Ohr Pharmaceutical, Ophthotech, Oraya, QLT, Regeneron Pharmaceuticals, Roche, Sequenom, Thrombogenics, Vertex, and Xcovery; has received research funding from Acucela , Aerpio , Alcon , Alimera , Allergan , Bayer , Fovea , Genentech , Genzyme , GlaxoSmithKline , LPath , Neovista , Neurotech , Notal Vision , Novartis , Ohr Pharmaceutical , Ophthotech , Paloma , and Regeneron Pharmaceuticals ; and has received travel support from Regeneron Pharmaceuticals. W.L.C. is a consultant for and has received research funding from Genentech, Regeneron Pharmaceuticals, Roche, and Santen; and has received travel support from Bayer and Regeneron Pharmaceuticals. D.S.B. is a consultant to Aeripo, Alcon, Allegro, Allergan, Bausch & Lomb, Bayer, Genentech, GlaxoSmithKline, Merck, Neurotech, Novartis, Ora, and Pfizer; and has received research funding from Alcon, Genentech, Pfizer, and Regeneron Pharmaceuticals and lecture fees from Allergan and Genentech. D.M.B. is a consultant to Alimera, Allergan, Bayer, Genentech, Novartis, Regeneron Pharmaceuticals, Roche, and Thrombogenics; has received research funding from Alimera, Allergan, Genentech, Novartis, Regeneron Pharmaceuticals, and Thrombogenics; and has received travel support from Regeneron Pharmaceuticals and Bayer. R.V., A.J.B., H.K., and Y.M. are employees of Regeneron Pharmaceuticals. B.S., O.Z., and R.S. are employees of Bayer HealthCare. J.A.H. is an advisory board member for Kal Vista and LPath and a consultant for Advanced Cell Technologies, Merck, Regeneron Pharmaceuticals, Second Sight, and ThromboGenics.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2014/7
Y1 - 2014/7
N2 - Purpose To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design Randomized, double-masked, phase 3 trial. Participants A total of 188 patients with macular edema secondary to CRVO. Methods Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN. Main Outcome Measures The primary efficacy end point was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results. Results The proportion of patients gaining ≥15 letters was 56.1% versus 12.3% (P<0.001) at week 24, 55.3% versus 30.1% (P<0.001) at week 52, and 49.1% versus 23.3% (P<0.001) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 (+17.3 vs. -4.0 letters; P<0.001), week 52 (+16.2 vs. +3.8 letters; P<0.001), and week 100 (+13.0 vs. +1.5 letters; P<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 μm (P<0.001) at week 24, 413.0 versus 381.8 μm at week 52 (P = 0.546), and 390.0 versus 343.3 μm at week 100 (P = 0.366) in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean number (standard deviation) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7±1.7 versus 3.9±2.0 during weeks 24 to 52 and 3.3±2.1 versus 2.9±2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively). Conclusions The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing, with a reduced monitoring frequency from weeks 52 to 100.
AB - Purpose To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO). Design Randomized, double-masked, phase 3 trial. Participants A total of 188 patients with macular edema secondary to CRVO. Methods Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN. Main Outcome Measures The primary efficacy end point was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results. Results The proportion of patients gaining ≥15 letters was 56.1% versus 12.3% (P<0.001) at week 24, 55.3% versus 30.1% (P<0.001) at week 52, and 49.1% versus 23.3% (P<0.001) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 (+17.3 vs. -4.0 letters; P<0.001), week 52 (+16.2 vs. +3.8 letters; P<0.001), and week 100 (+13.0 vs. +1.5 letters; P<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 μm (P<0.001) at week 24, 413.0 versus 381.8 μm at week 52 (P = 0.546), and 390.0 versus 343.3 μm at week 100 (P = 0.366) in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean number (standard deviation) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7±1.7 versus 3.9±2.0 during weeks 24 to 52 and 3.3±2.1 versus 2.9±2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively). Conclusions The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing, with a reduced monitoring frequency from weeks 52 to 100.
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U2 - 10.1016/j.ophtha.2014.01.027
DO - 10.1016/j.ophtha.2014.01.027
M3 - Article
C2 - 24679444
AN - SCOPUS:84903819352
VL - 121
SP - 1414-1420.e1
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 7
ER -