Phase III Multicenter Study to Assess Safety, Tolerability, and Effectiveness of SCT520FF in Treating Neovascular Age-Related Macular Degeneration in Adults 45 to 80

What this Trial Is About

Researchers are conducting a multicenter, open-label, dose-escalation and dose-expansion Phase III clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SCT520FF in patients with neovascular age-related macular degeneration nAMD. This study aims to understand how patients with this eye condition respond to SCT520FF treatment compared to a standard treatment called EYLEA 2 mg. The trial is sponsored by Sinocelltech Ltd. and focuses on adults aged 45 to 80 years with active nAMD lesions and specific vision criteria. Participants will be randomly assigned to one of four groups three different dose levels of SCT520FF 0.625 mg, 1.25 mg, and 2.5 mg administered by intravitreal injection once every four weeks for three continuous treatments, or the comparator group receiving EYLEA 2 mg via injection every four weeks during the study period. The study includes dose escalation and expansion phases to assess how well patients tolerate each dose and to monitor how the drug behaves in the body. Throughout the study, participants will undergo regular assessments including monitoring of treatment-emergent and treatment-related adverse events, serious adverse events, special interest adverse events, and dose-limiting toxicities from day 0 up to 196 days. Visual acuity and central retina thickness will be measured, along with pharmacokinetic and pharmacodynamic profiles and immunogenicity. The trial ensures comprehensive safety and efficacy evaluations over the study duration, allowing detailed observation of the drugs impact on patients eyes and overall health.

Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD