To determine safety, tolerability, and efficacy of intravitreal ranibizumab in the treatment of polypoidal choroidal vasculopathy in a non-Asian population.
Phase I/II, prospective, open-label, single-center, nonrandomized, uncontrolled, consecutive, interventional case series of 20 eyes in 19 patients with exudative active polypoidal choroidal vasculopathy. Eyes received 3 monthly intravitreal ranibizumab injections (0.3 or 0.5 mg), with additional ranibizumab injections, observation, or alternative treatments at investigators' discretion, through 24 months. Main outcome measures were ocular and systemic safety and mean change from baseline in best-corrected visual acuity and center point thickness.
Visually significant ocular adverse events included cataract progression (n = 3), mild vitreous hemorrhage (n = 2), and macular hole (n = 1). No systemic drug-related adverse events were observed. Mean baseline best-corrected visual acuity was 20/127 (range, 20/16–20/500) and center point thickness was 298 μm. Mean best-corrected visual acuity increased from baseline by 1.2 Snellen lines at 12 months and 24 months. Mean center point thickness decreased by 53 μm and 67 μm from baseline at 12 months and 24 months, respectively.
Intravitreal ranibizumab was well tolerated in non-Asian patients with polypoidal choroidal vasculopathy; the majority of eyes experienced improvements in best-corrected visual acuity and center point thickness after ranibizumab treatment.
Supplemental Digital Content is Available for the Text.Intravitreal ranibizumab for the treatment of polypoidal choroidal vasculopathy was well tolerated in non-Asian patients. The majority of eyes experienced improvements in best-corrected visual acuity and reductions in center point thickness after ranibizumab.
*Southeast Retina Center, Augusta, Georgia
†Department of Ophthalmology, University of South Carolina School of Medicine, Columbia, South Carolina
‡Mayo Clinic Health System, Waycross, Georgia
§Department of Ophthalmology, Northwestern University, Chicago, Illinois.
Reprint requests: Dennis M. Marcus, MD, 3685 Wheeler Rd., Augusta, GA 30909 e-mail: email@example.com
This study was funded as an investigator-initiated trial by Genentech, Inc., South San Francisco, CA. Editorial support was provided by Christina McManus, PhD, Envision Scientific Solutions, funded by Genentech, Inc. Drs D. M. Marcus and H. Singh have received research support from Genentech, Regeneron, Ophthotech, Allergan, Thrombogenics, Eli Lilly, Pfizer, and Neovista.
Portions of this work were presented at the 28th Annual Meeting of the American Society of Retina Specialists, Vancouver, British Columbia, Canada, August 28, to September 1, 2010.
All other authors have nothing to disclose. The authors have no proprietary interest.
D. M. Marcus is a consultant for Genentech, Inc.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).
Trial Registration: clinicaltrials.gov identifier: NCT00837330.