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T.A. Ciulla, C. Regillo, A. Desai, R. Levitt, J. Nau, C.A. Garcia; A Phase II, Multi–Center, Randomized, Controlled, Masked Study of the Effects of Squalamine Lactate in Combination With Visudyne® in Patients With Subfoveal Choroidal Neovascularization Associated With Age–Related Macular Degeneration . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2363.
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Purpose: To evaluate the safety profile and efficacy of squalamine lactate at three different doses in combination with photodynamic therapy (PDT) with verteporfin (Visudyne®) compared with the control group at weeks 29 and 76. Methods: Forty–five men and women more than 50 years of age with a diagnosis of subfoveal choroidal neovascularization (CNV) associated with AMD (predominantly classic, minimally classic or active occult angiographic subtypes) deemed suitable for PDT with verteporfin were treated. Squalamine lactate was infused intravenously (0.25 mg/mL concentration in D5W, 4.0 mL/min infusion rate) once a week, at weeks 1, 2, 4, 5, 9, 13, 17, 21 and 25. PDT was administered at week 3. If deemed necessary by the investigator and according to PDT re–treatment criteria, patients were re–treated with PDT at week 15 and/or 27. Patients were followed at weeks 29 (or 4 weeks following the final squalamine lactate infusion), 40, 52, 64 and 76. Patients were assigned to one of the following three parallel treatment groups at fifteen centers in the USA: Group A: 40 mg over 40 min; Group B: 20 mg over 20 min; Group C: 10 mg over 10 min, Group D, E, and F: Control (D5W). All patients, regardless of treatment group, were withdrawn from the study if their visual acuity deteriorated ≥ 15 letters on the ETDRS chart at two consecutive study visits. Results: To date there is no evidence of any adverse drug–drug interactions using this intensive drug regimen. There is a planned interim analysis of safety and efficacy when all patients have been treated for 9 weeks. Conclusions: Preliminary data suggest that these systemic drugs may be well tolerated when used concomitantly allowing exploration of any synergy between PDT verteporfin and squalamine lactate a systemic anti–angiogenic therapy. Additional squalamine lactate studies are planned in which PDT with verteporfin may be used concomitantly. More complete safety and efficacy data will be presented.
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