Despite a lack of retinal vasculitis seen during clinical trials of intravitreal pegcetacoplan injection for geographic atrophy, this American Society of Retina Specialists (ASRS) retrospective evaluation identified more than a dozen confirmed incidences of the condition since the drug’s approval in early 2023.
Study Design
The ASRS Research and Safety in Therapeutics (ReST) Committee conducted a retrospective analysis of cases of pegcetacoplan-associated retinal vasculitis that were submitted to the ASRS between April 25 and October 12, 2023. All available imaging and clinical data were reviewed.
Outcomes
Retinal vasculitis was reported in 14 eyes (13 patients), 79% of which had occlusive retinal vasculopathy. All cases occurred after the initial pegcetacoplan injection, with a median time to presentation of 10.5 days (range: 8–23 days). All affected patients presented with anterior chamber inflammation. Vitritis and retinal hemorrhage were other common clinical findings, each reported in 12 eyes. All vasculopathy cases involved retinal veins; 73% involved arteries. Prior to injection, median visual acuity (VA) was 20/60, declining to 20/300 at presentation with vasculitis. Median VA at last follow up was 20/200. Two eyes were enucleated, and 6 eyes had neovascularization of the anterior segment.
Limitations
The exact rate of retinal vasculitis cases after pegcetacoplan is still unknown due to the lack of information on the exact number of injections performed and the fact that not all instances may be reported to the ASRS ReST Committee.
Clinical Significance
Retinal vasculitis can be a significant concern with potentially severe visual impact. Although the etiology and exact incidence rate of retinal vasculitis after pegcetacoplan injection remain unknown, it is important to discuss this potential risk with patients who are undergoing intravitreal pegcetacoplan treatment, especially treatment-naive patients, and to monitor closely for any changes suggestive of retinal vasculitis during the first several weeks post-injection.
Financial Disclosures: Dr. Ajay Kuriyan discloses financial relationships with 4DMT, Adverum, Annexon, National Eye Institute, Novartis, Alcon Pharmaceuticals (Grant Support); Alimera Sciences, Allergan, Bausch + Lomb, EyePoint Pharmaceuticals (Consultant/Advisor); Iveric Bio, Optos (Lecture Fees/Speakers Bureau); Lumata Health, Recens Medical (Consultant/Advisor, Private Equity/Stock Holder); Spark Therapeutics (Consultant/Advisor, Lecture Fees/Speakers Bureau); Genentech (Consultant/Advisor, Lecture Fees/Speakers Bureau, Grant Support).