Original articleIntravitreal Aflibercept Injection for Macular Edema Secondary to Central Retinal Vein Occlusion: 1-Year Results From the Phase 3 COPERNICUS Study
Section snippets
Methods
The COPERNICUS study is an ongoing 2-year, phase 3, prospective, randomized, double-masked trial. This multicenter study was conducted across 70 sites in the United States, Canada, Colombia, India, and Israel. The study protocol of the COPERNICUS trial was approved by the institutional review board or ethics committee at each participating clinical center before the start of the study. This trial was registered with ClinicalTrials.gov (identifier #NCT00943072). All patients signed a written
Patient Disposition
A total of 189 patients were randomized to intravitreal aflibercept 2Q4 + PRN (n = 115) and sham + IAI PRN (n = 74). With the exception of 1 patient in the IAI 2Q4 + PRN group, all randomized patients received study drugs. The majority of patients (57/74, 77.0% sham + IAI PRN and 107/115, 93.0% IAI 2Q4 + PRN) completed the first 52 weeks of the study (Supplemental Figure 2, available at AJO.com). The primary reasons for premature discontinuation from the study before week 52 were withdrawal of
Discussion
The COPERNICUS study results from week 24 through week 52 demonstrate that the robust elimination of retinal edema on OCT and the concomitant BCVA gains achieved after 6 monthly intravitreal aflibercept injections in the IAI 2Q4group can be largely maintained with less frequent dosing of a mean 2.7 injections. It must be noted that patients continued to be evaluated monthly during the PRN phase. Careful monitoring in clinical practice may be critical to achieve this result in a reactive PRN
David M. Brown, a graduate of Baylor College of Medicine, is a retina specialist in Retina Consultants of Houston, Texas, and directs one of the largest clinical trial centers for retinal disease in the United States. His research and clinical interests are focused on macular surgery, AMD, and diabetic retinopathy. Dr Brown has published and written over 150 national meeting presentations, abstracts, and scientific papers, including many of the primary papers on anti-VEGF agents.
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David M. Brown, a graduate of Baylor College of Medicine, is a retina specialist in Retina Consultants of Houston, Texas, and directs one of the largest clinical trial centers for retinal disease in the United States. His research and clinical interests are focused on macular surgery, AMD, and diabetic retinopathy. Dr Brown has published and written over 150 national meeting presentations, abstracts, and scientific papers, including many of the primary papers on anti-VEGF agents.
Julia Haller, MD, is Ophthalmologist-in-Chief and the William Tasman, Endowed Chair in Ophthalmology at Wills Eye Institute, Philadelphia, Pennsylvania. She also serves as Professor and Chair of the Department of Ophthalmology at Jefferson Medical College of Thomas Jefferson University. Her primary research interests are retinal detachments, macular surgery, RVO, AMD, posterior segment inflammatory diseases, and diabetic retinopathy. Dr Haller has published over 250 peer-reviewed articles and is on the editorial board of 8 journals.