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LJ SingermanEyeTech Study Group; Anti-VEGF Therapy for Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration: Phase IB Results . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2908.
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Purpose: Research suggests that anti-vascular endothelial growth factor (VEGF) therapy may be useful in the treatment of ocular neovascularization. A Phase IA study of a single intravitreal injection of anti-VEGF in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) revealed a good safety profile. To determine the safety profile of multiple-injection therapy, we performed a Phase IB study of multiple injections of anti-VEGF, with or without photodynamic therapy (PDT), in patients with subfoveal CNV secondary to AMD. Methods: A Phase IB multiple-dose study of intravitreal injection of the drug, with or without PDT, was performed in 21 patients with subfoveal CNV secondary to AMD. Results: There were no significant safety issues related to the drug. Ophthalmic evaluation 3 months after treatment showed that 87.5% of patients who received only the anti-VEGF aptamer showed stable or improved vision and that 25% demonstrated a 3-line or greater improvement in vision on the ETDRS chart. A 3-line gain at 3 months was observed in 60% of patients who received both the anti-VEGF aptamer and photodynamic therapy. Conclusion: Anti-VEGF therapy is a promising treatment of neovascularization secondary to various ocular diseases, including AMD. In this Phase IB study, multiple intravitreal injections of the anti-VEGF aptamer were well tolerated, and visual results were very encouraging. Further clinical trials are required, and a Phase III study to evaluate the efficacy and long-term safety of this treatment is currently underway at 115 centers in the USA and abroad.
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