April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
VEGF Trap-Eye In CRVO: Primary Endpoint Results Of The Phase 3 COPERNICUS Study
Julia A. Haller; David S. Boyer; Jeffrey S. Heier; David M. Brown; Lloyd Clark; Robert Vitti
Author Affiliations & Notes
  • Julia A. Haller
    Ophthalmology, Wills Eye Institute, Philadelphia, Pennsylvania
  • David S. Boyer
    Ophthalmology, Retina Vitreous Assoc Med Group, Los Angeles, California
  • Jeffrey S. Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts
  • David M. Brown
    Retina Consultants of Houston, Houston, Texas
  • Lloyd Clark
    Palmetto Retina Center, West Columbia, South Carolina
  • Robert Vitti
    Regeneron Pharmaceuticals, Inc., Tarrytown, New York
  • Footnotes
    Commercial Relationships  Julia A. Haller, Regeneron Pharmaceuticals, Inc. (C); David S. Boyer, Regeneron Pharmaceuticals, Inc. (C); Jeffrey S. Heier, Alcon Laboratories, Allergan, Bausch & Lomb, Genentech, Novartis Pharmaceuticals, Regneron Pharmaceuticals, Inc, (C), Allergan, Genentech, Novartis Pharmaceuticals, Pfizer Ophthalmics, Regeneron Pharmaceuticals, Inc. (F); David M. Brown, Alcon Laboratories, Allergan, Genentech, Novartis Pharmaceuticals, Pfizer Ophthalmics, Regeneron Pharmaceuticals, Inc. (F), Alcon Laboratories, Allergan, Carl Zeiss Meditec, Genentech, Novartis Pharmaceuticals, Pfizer Ophthalmics, Regeneron Pharmaceuticals, Inc. (C); Lloyd Clark, Regeneron Pharmaceuticals, Inc. (C); Robert Vitti, Regeneron Pharmaceuticals Inc. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 6643. doi:
  • Views
  • Share
  • Tools
    • Alerts
      User Alerts
      You are adding an alert for:
      VEGF Trap-Eye In CRVO: Primary Endpoint Results Of The Phase 3 COPERNICUS Study
      You will receive an email whenever this article is corrected, updated, or cited in the literature. You can manage this and all other alerts in My Account
      The alert will be sent to:
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation
      Citation

      Julia A. Haller, David S. Boyer, Jeffrey S. Heier, David M. Brown, Lloyd Clark, Robert Vitti; VEGF Trap-Eye In CRVO: Primary Endpoint Results Of The Phase 3 COPERNICUS Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6643.

      Download citation file:

      © ARVO (1962-2015); The Authors (2016-present)

      ×
    • Get Permissions
  • Supplements
Abstract

Purpose: : VEGF Trap-Eye is an intravitreally administered fusion protein that is designed to bind the pro-angiogenic factors VEGF-A and placental growth factor with higher affinity than their natural receptors. This study evaluated the efficacy and safety of VEGF Trap-Eye in patients with macular edema secondary to central retinal vein occlusion (CRVO) after 24 weeks of treatment.

Methods: : In this randomized, double-masked, controlled Phase 3 study, 114 patients received 6 monthly injections of 2 mg VEGF Trap-Eye and 73 patients received control sham injections. Visual acuity was measured as a score based on the total number of Early Treatment of Diabetic Retinopathy Study (ETDRS) letters read correctly. The primary endpoint was the proportion of patients who gained at least 15 ETDRS letters from baseline at 24 weeks. A key secondary endpoint was the mean change in best-corrected visual acuity from baseline at 24 weeks.

Results: : The primary endpoint was met in this study: 56.1% of patients receiving 2 mg VEGF Trap-Eye monthly gained at least 15 letters of vision from baseline, compared with 12.3% of patients receiving sham injections (p<0.0001). Patients receiving VEGF Trap-Eye gained a mean of 17.3 letters of vision compared with a mean loss of 4.0 letters with sham injection (p<0.001). The most common adverse events were those typically associated with intravitreal injections and/or the underlying disease. The proportions of patients who experienced serious ocular adverse events were 3.5% in the VEGF Trap-Eye group and 13.5% in the sham group. The incidence of non-ocular serious adverse events was generally well balanced between the treatment and sham groups.

Conclusions: : Dosing monthly with 2 mg VEGF Trap-Eye in patients with macular edema secondary to CRVO resulted in a statistically significant improvement in visual acuity compared with control sham treatment. VEGF Trap-Eye was generally well tolerated and had a generally favorable safety profile.

Clinical Trial: : http://www.clinicaltrials.gov NCT00943072

Keywords: vascular endothelial growth factor • visual acuity • vascular occlusion/vascular occlusive disease 
© 2011, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Copyright © 2025 Association for Research in Vision and Ophthalmology.
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×
This site uses cookies. By continuing to use our website, you are agreeing to our privacy policy.Accept