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D.J. D'Amico, A.C. Bird; VEGF Inhibition Study in Ocular Neovascularization–1 (VISION–1): Safety Evaluation From the Pivotal MacugenTM (Pegaptanib Sodium) Clinical Trials . Invest. Ophthalmol. Vis. Sci. 2004;45(13):2363.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To assess the safety of Macugen, a vascular endothelial growth factor (VEGF) antagonist, in the treatment of exudative age–related macular degeneration (AMD). Methods: Two pivotal phase 2/3 randomized, double–masked, multicenter, dose–finding studies in patients with all three subtypes of neovascular AMD were performed. Patients received either intravitreal Macugen (0.3 mg, 1 mg, or 3 mg administered as 100 µL injections) or sham injection every 6 weeks for 54 weeks. Adverse events not necessarily related to the use of study drug, but temporally associated with treatment were assessed by the ophthalmologist at each visit. Safety evaluations included patients receiving at least one dose of study drug. Results: Safety analyses included 1190 patients (0.3 mg, N=295; 1 mg, N=301; 3 mg, N=296; sham, N=298), and more than 7500 intravitreal injections of Macugen were administered. Regarding ocular safety, Macugen was well–tolerated at all three doses. Most adverse events reported in study eyes were transient, mild to moderate in severity, and attributed by investigators to the injection procedure rather than to study drug. The only ocular adverse event reported in >10% more study eyes treated with Macugen as compared with sham was the presence of vitreous floaters (33% versus 8%, respectively). Rates of injection–related complications were endophthalmitis (12 events, 0.16%/injection, 1.3%/patient), retinal detachment (5 events, 0.07%/injection, 0.6%/patient), traumatic cataract (5 events, 0.07%/injection, 0.6%/patient); rates were consistent with historical comparisons. No evidence of persistently elevated intraocular pressure following multiple intravitreal injections was found. Macugen was well–tolerated systemically at all three doses and no apparent safety signals for cardiac events were seen. No serious adverse events were attributed definitively to study drug. Analyses of laboratory data are ongoing. Conclusion: The anti–VEGF selective aptamer, Macugen, had a favorable safety profile in patients with exudative AMD at 54 weeks.
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