Abstract
BackgroundTo evaluate the safety of pegaptanib sodium 0.3 mg intravitreal injection in the treatment of neovascular age-related macular degeneration in subjects with or without diabetes mellitus.MethodsA pooled, retrospective, analysis was conducted of data from 9 sponsor-administered, randomized, open-label trials. Subjects who received pegaptanib by randomization or change in dose assignment, crossover design, or protocol amendment, were included. Reports of endophthalmitis, increased intraocular pressure, retinal injury, intraocular hemorrhage, traumatic cataract, hypersensitivity reactions, stroke, myocardial infarction, and other arterial thromboembolic events defined by the Antiplatelet Trialists’ Collaboration were identified by Medical Dictionary for Regulatory Activities preferred terms. Adverse events were summarized from the first injection to 42 days after the last injection. The incidence of adverse events was stratified by the presence/absence of diabetes.ResultsOf 1,586 subjects enrolled, 165 (10.4%) had a history of diabetes mellitus and 1,421 (89.6%) did not. The 2 populations were similar at baseline. Based on the comparison of prespecified ocular, hypersensitivity, and Antiplatelet Trialists’ Collaboration event terms, the safety review did not identify any notable differences between the 2 populations.ConclusionsThis retrospective analysis found no increased safety risk resulting from treatment with pegaptanib 0.3 mg in individuals with neovascular age-related macular degeneration and concomitant diabetes mellitus.
Highlights
To evaluate the safety of pegaptanib sodium 0.3 mg intravitreal injection in the treatment of neovascular age-related macular degeneration in subjects with or without diabetes mellitus
Inflammation is thought to play an important role in the pathophysiology of diabetic retinopathy (DR) [1,2,3] with elevated levels of vascular endothelial growth factor (VEGF) being a key mediator [4]
This pooled retrospective analysis evaluated the occurrence of prespecified adverse events in subjects with or without diabetes mellitus who were treated with pegaptanib sodium injection (Macugen, Eyetech Inc) for age-related macular degeneration (AMD)
Summary
To evaluate the safety of pegaptanib sodium 0.3 mg intravitreal injection in the treatment of neovascular age-related macular degeneration in subjects with or without diabetes mellitus. Because there is a lack of large, comparative studies examining the systemic effects of anti-VEGF therapies, understanding the implications of administering these agents in individuals with diabetes is important information for the clinician. This retrospective analysis was performed to evaluate the safety of pegaptanib in the subset of patients with diabetes who were receiving pegaptanib for AMD (data on file, Pfizer Inc) [19,20]
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