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C.R. Beals, N. Ting, M. Patel, B. Katz, M. Goldbaum; Patients with Choroidal Neovascularization Arising Outside the Fovea: Treatment with Pegaptanib Sodium After Thermal Laser Photocoagulation Failure . Invest. Ophthalmol. Vis. Sci. 2006;47(13):4259.
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This exploratory post hoc analysis of patients from the V.I.S.I.O.N. (VEGF Inhibition Study in Ocular Neovascularization) trial database examined the effect of pegaptanib sodium on visual outcomes in patients with lesions arising outside of the fovea which had recurred following thermal laser treatment.
The V.I.S.I.O.N. trial comprised 2 concurrent, randomized, double–masked multicenter studies and included patients with all angiographic subtypes and sizes of neovascular age–related macular degeneration. In year 1, patients received either intravitreous pegaptanib (0.3 mg, 1 mg, or 3 mg) or sham injections (usual care) given at 6–weekly intervals for 54 weeks. Subjects receiving thermal laser treatment in the study eye for nonfoveal choroidal neovascularization were identified, excluding cases of photodynamic therapy, or laser treatment for glaucoma or directed to the lens capsule.
A total of 103 patients were identified. As in the overall trial, patients with a prior history of thermal laser photocoagulation treated with pegaptanib had better vision outcomes than patients receiving usual care. For the 0.3 mg (approved) dose, the responder rate (proportion of subjects losing <15 letters of visual acuity [VA]) at week 12 was 84% versus 52% for usual care (P=0.019) and at week 54 was 68% versus 43% for usual care (P=0.093). Subjects receiving usual care were approximately 4 times more likely to lose ≥30 letters of VA than those treated with 0.3 mg pegaptanib (35% versus 8%, respectively; P=0.0241). The early and sustained effect of pegaptanib in patients with juxtafoveal or extrafoveal lesions was reflected in changes in VA from baseline to week 54. By week 54, the usual care group had experienced significantly greater declines in mean VA compared with the 0.3 mg group (–21.78 letters versus –11.22 letters, respectively; P=0.0056).
The results of this exploratory subanalysis of the V.I.S.I.O.N. trial data suggest that pegaptanib sodium is effective in patients with extra– and juxta–foveal neovascular age–related macular degeneration who received prior thermal laser treatment.
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