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Br J Ophthalmol 2008;92:1606-1611 doi:10.1136/bjo.2007.132597
  • Original Article

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

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  1. L J Singerman1,
  2. H Masonson2,
  3. M Patel3,
  4. A P Adamis4,
  5. R Buggage5,
  6. E Cunningham6,7,
  7. M Goldbaum8,
  8. B Katz9,
  9. D Guyer10
  1. 1
    Retina Associates of Cleveland, Cleveland, Ohio, USA
  2. 2
    Ophthotech Corporation, Princeton, New Jersey, USA
  3. 3
    Optherion Inc, New Haven, Connecticut, USA
  4. 4
    Jerini Ophthalmic, New York, USA
  5. 5
    Pfizer, New York, New York, USA
  6. 6
    California Pacific Medical Center, San Francisco, California, USA
  7. 7
    Department of Ophthalmology, Stanford University School of Medicine, Stanford, California, USA
  8. 8
    Eyetech Inc, New York, New York, USA
  9. 9
    Danube Pharmaceutials Inc, New York, New York, USA
  10. 10
    SV Life Sciences, Boston, Massachusetts, USA
  1. Dr L J Singerman, Retina Associates of Cleveland, 3401 Enterprise Parkway, Suite 300, Cleveland, OH 44122, USA; lsingerman{at}retina-assoc.com
  • Accepted 2 May 2008
  • Published Online First 9 July 2008

Abstract

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.

Footnotes

  • Funding: This study was sponsored by (OSI) Eyetech Inc, New York and Pfizer Inc, New York. Both sponsors participated in the study design, data analysis and interpretation, and preparation and review of the manuscript.

  • Competing interests: LJS has received grant/research support from (OSI) Eyetech, Pfizer, Novartis, QLT, Alcon, Genentech, Bausch & Lomb, Opko (formerly Acuity), Allergan, has been a consultant for (OSI) Eyetech, Pfizer, Novartis, Genaera, Lilly, Opko (formerly Acuity), had been on the speakers bureau for (OSI) Eyetech, Pfizer and Novartis, and is currently on the Opko speakers bureau. HM is affiliated with and has ownership interest in (OSI) Eyetech; MP is employed by Optherion. APA is affiliated with (OSI) Eyetech and Jerini Ophthalmic and has ownership in Jerini Ophthalmics. RB is employed by Pfizer. MG is employed by (OSI) Eyetech. BK was affiliated with and has ownership in (OSI) Eyetech and is affiliated with and has ownership in Danube Pharmaceuticals. EC and DG have no financial interests to disclose. HM, APA, EC, BK and DG were employees of (OSI) Eyetech, New York, and MP an employee of Pfizer at the time the study was designed and conducted.

  • Ethics approval: The study protocol was received and approved by an institutional review board at each study site.

  • Patient consent: Obtained.

  • This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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