Ocular Safety of Intravitreal Injections of Age-Related Macular Degeneration Treatments in a Prospective Observational Cohort Study in Europe

Abstract

Background: AMD is the leading cause of blindness in persons 65 years of age or older in western populations. Macugen was the first approved intravitreal vascular endothelial growth factor (VEGF) antagonist treating AMD in Europe. Objectives: To estimate the incidence of pertinent ocular adverse events (POAEs) related to intravitreal injection (IVT) of Macugen in Europe. Methods: This prospective, multinational, observational study was conducted at ophthalmic clinical centers in Europe. The study population consisted of patients who received at least one IVT of Macugen. Ophthalmologists prospectively followed patients and determined outcomes of interest as clinically appropriate. POAEs included endophthalmitis, retinal detachment, vitreous hemorrhage, retinal tear, traumatic cataract, increased intraocular pressure (IOP). Results: Five hundred and one patients from 69 sites in 13 countries were enrolled. The mean age was 73.6 years. Most patients received Macugen monotherapy (80.4%), were white (97.4%), and never smoked (65.3%). 11.8% of patients received IVT AMD treatment in both eyes. The mean number of Macugen injections was 6.9 + 4.2 injections. The incidence of POAEs was low overall (0 to 1.3% per injection, 0 to 6.6% per patient, and 0 to 75.9 patients per 1,000 patient-years at risk). Increased IOP was the most frequently reported POAE (1.3% per injection, 6.6% per patient, and 75.9 patients per 1,000 patient-years at risk), with a total of 48 occurrences in 33 patients. There was a positive association between the incidence of increased IOP and the number of injections received. Endophthalmitis was not reported. Conclusions: The incidence of POAEs related to IVT in this study was low and similar to that in the literature. Macugen was safe and well tolerated among patients in the study.