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EL Thomas, CS Tressler, RP Murphy; Efficacy of SnET2 Photodynamic Therapy for Choroidal Neovascularization in Age-related Macular Degeneration: Phase III Pivotal Trial Results . Invest. Ophthalmol. Vis. Sci. 2002;43(13):983.
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Purpose: To review the safety and efficacy data from 933 eyes treated with SnET2 photodynamic therapy for choroidal neovascularization (CNV) in Age-Related Macular Degeneration (AMD) in two, parallel, masked, pivotal Phase III trials. Methods: 933 eyes were randomized in a Phase III pivotal trial to placebo, SnET2 at 0.50 mg/kg or 0.75 mg/kg for a 1:2:2 ratio. All lesions were exposed to 664 nm light for photodynamic activation. Eligible lesions were required to have some element of classic CNV, to be less than 3,000m maximum diameter for initial treatment and to be less 4,500m for recurrent treatment was allowed at 90 days following the previous treatment. ETDRS visual acuities, clinical examination and an independent fluorescein angiographic reading center were used to evaluate clinical response to treatment. Results: Data collected through November, 2001 ( a two year follow-up from entry) will be presented for all evaluable patients. Conclusion: Two-year data for safety and efficacy of a pivotal Phase III Trial for the safety and efficacy of SnET2 photodynamic therapy for CNV due to AMD are available.
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