Neovascular Age-Related Macular Degeneration Clinical Trial
Official title:
A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)
Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. The safety and efficacy of brolucizumab were assessed in 2 randomized, multicenter, double-masked, active treatment-controlled Phase 3 studies in nAMD patients (the HAWK study (RTH258-C001 [NCT02307682]) and the HARRIER study (RTH258-C002 [NCT02434328]). Accordingly, a new Phase 3b study (TALON, CRTH258A2303) is being conducted to evaluate the efficacy and safety of brolucizumab in a Treat-to-Control (TtC) regimen for the treatment of naïve patients with nAMD. In this TtC regimen, patients receive 3 consecutive injections every 4 weeks and then the injection interval is extended by 4 weeks up to a maximum of a 16-week interval. The decision to extend or reduce the injection interval is taken by the Investigator at each visit based on his/her judgment of disease activity, according to the patient visual and/or anatomic outcomes. If there is no disease activity, the injection interval can be extended by 4 weeks ; if disease activity occurs or recurs, the injection interval should be shortened accordingly by 4 weeks at a time or to a minimal interval of 8 weeks. The injection interval can also be maintained if the Investigator deems that the patient do not benefit from injection interval adjustment. Since all these studies were conducted in a naïve nAMD patient population, no data are available on the efficacy and safety of brolucizumab in pretreated nAMD patients who still present active exudation.
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