Year 2 Efficacy Results of 2 Randomized Controlled Clinical Trials of Pegaptanib for Neovascular Age-Related Macular Degeneration
Study results presented in part at: Association for Research in Vision and Ophthalmology Annual Meeting, May 2005, Fort Lauderdale, Florida.
Received 10 November 2005; accepted 14 February 2006. published online 06 July 2006.
Objective
To evaluate the efficacy of a second year of pegaptanib sodium therapy in patients with neovascular age-related macular degeneration (AMD).
Design
Two concurrent, multicenter, randomized, double-masked, sham-controlled studies (V.I.S.I.O.N. [Vascular Endothelial Growth Factor Inhibition Study in Ocular Neovascularization] trials).
Participants
Patients with all angiographic neovascular lesion compositions of AMD were enrolled. In combined analyses, 88% (1053/1190) were re-randomized at week 54, and 89% (941/1053) were assessed at week 102.
Interventions
At week 54, those initially assigned to pegaptanib were re-randomized (1:1) to continue or discontinue therapy for 48 more weeks (8 injections). Those initially assigned to sham were re-randomized to continue sham, discontinue sham, or receive 1 of 3 pegaptanib doses.
Main Outcome Measures
Mean change in visual acuity (VA) over time and mean change in the standardized area under the curve of VA and proportions of patients experiencing a loss of ≥15 letters from week 54 to week 102; losing <15 letters (responders) from baseline to week 102; gaining ≥0, ≥1, ≥2, and ≥3 lines of VA; and progressing to legal blindness (20/200 or worse).
Results
In combined analysis, mean VA was maintained in patients continuing with 0.3-mg pegaptanib compared with those discontinuing therapy or receiving usual care. In patients who continued pegaptanib, the proportion who lost >15 letters from baseline in the period from week 54 to week 102 was half (7%) that of patients who discontinued pegaptanib or remained on usual care (14% for each). Kaplan–Meier analysis showed that patients continuing 0.3-mg pegaptanib for a second year were less likely to lose ≥15 letters than those re-randomized to discontinue after 1 year (P<0.05). The proportion of patients gaining vision was higher for those assigned to 2 years of 0.3-mg pegaptanib than receiving usual care. Progression to legal blindness was reduced for patients continuing 0.3-mg pegaptanib for 2 years.
Conclusions
Continuing visual benefit was observed in patients who were randomized to receive therapy with pegaptanib in year 2 of the V.I.S.I.O.N. trials when compared with 2 years’ usual care or cessation of therapy at year 1.
Manuscript no. 2005-1091.
Study sponsored by Eyetech Pharmaceuticals, Inc., New York, New York, and Pfizer Inc., New York, New York.
Correspondence and reprint requests to Usha Chakravarthy, MD, Centre for Vision Sciences, The Queen’s University of Belfast and The Royal Victoria Hospital, Belfast BT12 6BA, Northern Ireland, United Kingdom. E-mail: u.chakravarthy@qub.ac.uk.
⁎ Members of the study group taking authorship responsibility for this article and who had complete access to the data needed for this report are listed in “Appendix I” along with their pertinent financial conflict-of-interest statements.
ABSTRACT