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J.S. Slakter, J.A. Sorenson, R.F. Spaide, K.B. Freund; Evaluation of the safety and efficacy of Anecortave Acetate 15 mg for Depot Suspension and triamcinolone acetate 4mg or a combination of both in patients with exudative age–related macular degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2004;45(13):1927.
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Purpose: To evaluate the safety and efficacy of combining Anecortave Acetate 15 mg Depot with intravitreal injection of triamcinolone acetate 4 mg versus using each agent alone for treatment of exudative AMD. Methods: A total of 65 patients with either 1) subfoveal occult only choroidal neovascularization (CNV) with demonstrated disease progression, or 2) subfoveal minimally classic CNV will be enrolled. The first 5 patients are treated in an open label fashion, assigned to receive both Anecortave Acetate 15mg Depot delivered by posterior juxtascleral administration and triamcinolone acetate 4mg delivered by intravitreal injection. These patients serve as a preliminary safety assessment for the combination procedure. When all 5 complete the month 3 visit, the remaining 60 patients are enrolled in a masked fashion in a 1:1:1 ratio assigned to receive either anecortave acetate 15mg with sham intravitreal injection, triamcinolone acetate 4mg delivered by intravitreal injection with sham posterior juxtascleral administration, or a combination of both. Baseline and follow–up examinations include best–corrected ETDRS visual acuity (VA), intraocular pressure assessment, optical coherence tomography (OCT–3), and fluorescein angiography (FA) for this 2 yr study. Results: The mean change from baseline in ETDRS VA for patients undergoing treatment will be shown. Additional efficacy parameters presented include percentage of patients demonstrating moderate (>3 ETDRS lines) or severe (≥6 ETDRS line) vision loss as well as effectiveness in controlling the degree of neovascular growth as demonstrated by FA. Conclusions:Given the nature of these two drugs, it is possible that a combination of the agents may provide a synergistic effect, with the strong anti–permeability effect of the steroid combined with the anti–angiogenic effect of anecortave acetate resulting in improved visual and anatomic outcomes.
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