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R. S. Apte, Ophthotech Anti-Complement in AMD Study Group; Targeting Complement Factor 5 in Neovascular Age-Related Macular Degeneration (NV-AMD) - Results of a Phase 1 Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5011.
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To assess the safety of intravitreal ARC1905, a Complement Factor 5 inhibitor, in combination with ranibizumab for the treatment of NV-AMD.
This is a two-part Phase 1 open-label safety study. In Part 1, the ascending dose part of the study, subjects receive 3 monthly intravitreal administrations of ARC1905 at one of 4 doses (0.03, 0.3, 1, and 3 mg/eye) in combination with monthly ranibizumab 0.5 mg/eye. In Part 2, the parallel group part of the study, two ARC1905 dose levels will be chosen based on the results of Part 1 of the study. Subjects will receive 3 monthly intravitreal administrations of ARC1905 in varying regimens with ranibizumab 0.5 mg.
In Part 1 of the study, the low dose (0.03 mg) cohort has been fully enrolled (3 patients) and 2 patients have been enrolled in the 0.3 mg cohort. To date, these patients have been followed for up to 4 weeks. The combination of this anti-C5 complement agent and an anti-VEGF agent in 5 patients revealed no acute toxicity to date. No evidence of drug-related adverse events was detected, and the few ocular adverse events noted were mild and associated with the intravitreal injection.
Initial results of a phase 1 study investigating Complement Factor 5 inhibition in combination with an anti-VEGF agent revealed no signs of acute toxicity. Preclinical and genetic linkage studies implicate complement-mediated inflammation in AMD. Targeting complement activation may inhibit the process of choroidal neovascularization. Inhibition of complement activation via targeting Complement Factor 5 is a promising approach for therapeutic intervention in AMD.
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