Pegaptanib sodium for neovascular age-related macular degeneration: Third-year safety results of the VEGF inhibition study in ocular neovascularisation (VISION) trial

L. J. Singerman, H. Masonson, M. Patel, A. P. Adamis, R. Buggage, E. Cunningham, M. Goldbaum, Barrett Katz, D. Guyer

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1606-1611
Number of pages6
JournalBritish Journal of Ophthalmology
Volume92
Issue number12
DOIs
StatePublished - Dec 2008
Externally publishedYes

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Macular Degeneration
Vascular Endothelial Growth Factor A
Safety
Therapeutics
pegaptanib
Injections
Vital Signs
Double-Blind Method
Electrocardiography

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Pegaptanib sodium for neovascular age-related macular degeneration : Third-year safety results of the VEGF inhibition study in ocular neovascularisation (VISION) trial. / Singerman, L. J.; Masonson, H.; Patel, M.; Adamis, A. P.; Buggage, R.; Cunningham, E.; Goldbaum, M.; Katz, Barrett; Guyer, D.

In: British Journal of Ophthalmology, Vol. 92, No. 12, 12.2008, p. 1606-1611.

Research output: Contribution to journalArticle

Singerman, L. J. ; Masonson, H. ; Patel, M. ; Adamis, A. P. ; Buggage, R. ; Cunningham, E. ; Goldbaum, M. ; Katz, Barrett ; Guyer, D. / Pegaptanib sodium for neovascular age-related macular degeneration : Third-year safety results of the VEGF inhibition study in ocular neovascularisation (VISION) trial. In: British Journal of Ophthalmology. 2008 ; Vol. 92, No. 12. pp. 1606-1611.
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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.",
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