ORIGINAL ARTICLES

Pegaptanib sodium for neovascular age-related macular degeneration: third-year safety results of the VEGF Inhibition Study in Ocular Neovascularisation (VISION) trial

L J Singerman¹, H Masonson², M Patel³, A P Adamis⁴, R Buggage⁵, E Cunningham^6,7, M Goldbaum⁸, B Katz⁹ and D Guyer¹⁰

¹ Retina Associates of Cleveland, Cleveland, Ohio, USA
² Ophthotech Corporation, Princeton, New Jersey, USA
³ Optherion Inc, New Haven, Connecticut, USA
⁴ Jerini Ophthalmic, New York, USA
⁵ Pfizer, New York, New York, USA
⁶ California Pacific Medical Center, San Francisco, California, USA
⁷ Department of Ophthalmology, Stanford University School of Medicine, Stanford, California, USA
⁸ Eyetech Inc, New York, New York, USA
⁹ Danube Pharmaceutials Inc, New York, New York, USA
¹⁰ SV Life Sciences, Boston, Massachusetts, USA

Correspondence to:
Dr L J Singerman, Retina Associates of Cleveland, 3401 Enterprise Parkway, Suite 300, Cleveland, OH 44122, USA; lsingerman{at}retina-assoc.com

Aims: To evaluate the safety of up to 3 years of pegaptanib sodium therapy in the treatment of neovascular age-related macular degeneration (NV-AMD).

Methods: Two concurrent, prospective, multicentre, double-masked studies randomised subjects with all angiographic lesion compositions of NV-AMD to receive intravitreous pegaptanib sodium (0.3, 1 and 3 mg) or sham injections every 6 weeks for 54 weeks. Those initially assigned to pegaptanib were rerandomised to continue or discontinue therapy for 48 more weeks; sham-treated subjects continued sham, discontinued or received pegaptanib. At 102 weeks, subjects receiving pegaptanib 0.3 mg or 1 mg in years 1 or 2 continued; those receiving pegaptanib 3 mg or who did not receive treatment in years 1 and 2 were rerandomised to 0.3 mg or 1 mg for year 3.

Results: As in years 1 and 2, pegaptanib was well tolerated in year 3. Adverse events were mainly ocular in nature, mild, transient and injection-related. Serious adverse events were rare. No evidence of systemic safety signals attributed to vascular endothelial growth factor inhibition arose in year 3. There were no findings in relation to vital signs or electrocardiogram results suggesting a relationship to pegaptanib treatment.

Conclusion: The 3-year safety profile of pegaptanib sodium was favourable in patients with NV-AMD.

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