Original ArticleYear 2 Efficacy Results of 2 Randomized Controlled Clinical Trials of Pegaptanib for Neovascular Age-Related Macular Degeneration
Section snippets
Study Design
Two concurrent, randomized, double-masked, sham-controlled dose-ranging studies (studies 1003 and 1004) enrolled patients at sites in the U.S., Canada, Europe, Israel, Australia, and South America. Institutional review board/ethics committee approval was obtained at each participating center. Eligibility criteria ensured the inclusion of patients with a broad range of visual acuity (VA) and neovascular AMD characteristics.32 In brief, ≥50-year-old patients with subfoveal choroidal
Patient Disposition
Figure 1 illustrates randomization and re-randomization at baseline and week 54 and patient flow. Eighty-eight percent (1053/1190) of patients who received at least 1 treatment were re-randomized at week 54; 89% (941/1053) of patients re-randomized at week 54 were assessed at week 102, and percentages were similar across study arms. The primary reason for patient withdrawal before re-randomization was patient request; less frequent reasons included protocol deviation and loss to follow-up. Note
Discussion
The wide eligibility criteria in the V.I.S.I.O.N. trials permitted enrollment of a diverse mix of neovascular AMD presentations. Specifically, occult-only or any combination of occult and classic angiographic lesion compositions was eligible. Furthermore, highly aggressive lesions with up to 6 disc areas of hemorrhage as well as more chronic lesions with up to 25% scarring and fibrosis were eligible. To avoid enrollment of totally quiescent or involuted occult lesions, documented evidence of a
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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: [email protected].
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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.