TY - JOUR
T1 - Pegaptanib sodium for neovascular age-related macular degeneration
T2 - Third-year safety results of the VEGF inhibition study in ocular neovascularisation (VISION) trial
AU - Singerman, L. J.
AU - Masonson, H.
AU - Patel, M.
AU - Adamis, A. P.
AU - Buggage, R.
AU - Cunningham, E.
AU - Goldbaum, M.
AU - Katz, B.
AU - Guyer, D.
PY - 2008/12
Y1 - 2008/12
N2 - 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.
AB - 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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U2 - 10.1136/bjo.2007.132597
DO - 10.1136/bjo.2007.132597
M3 - Article
C2 - 18614570
AN - SCOPUS:57149091202
SN - 0007-1161
VL - 92
SP - 1606
EP - 1611
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
IS - 12
ER -