Phase 12 Study of PRL3-zumab Treatment for Neovascular Age-related Macular Degeneration nAMD with 3 Doses Given Intravenously

What this Trial Is About

Researchers are evaluating the safety and effectiveness of PRL3-zumab in patients with Neovascular Age-related Macular Degeneration nAMD who have not responded to standard treatments. This Phase III, randomized, single-blind, placebo-controlled trial aims to confirm the recommended dose of PRL3-zumab and assess its impact on vision and retinal thickness. The study is sponsored by Intra-IMMUSG Pte Ltd and involves three groups receiving different doses or placebo. Participants will receive PRL3-zumab intravenously at doses of 3 mgkg or 6 mgkg, or a placebo of normal saline. Treatments are given three times every two weeks during the initial 4 weeks. After treatment, all participants undergo 20 weeks of monitoring, with eye exams every 4 weeks to assess vision and retinal changes. If disease activity returns, additional open-label PRL3-zumab treatment may be given based on specific clinical criteria. During the study, safety is closely monitored through adverse event reporting, physical exams, vital signs, and laboratory tests. Vision is measured using the Early Treatment Diabetic Retinopathy Study ETDRS letter score, and retinal thickness and fluid are assessed with Optical Coherence Tomography OCT. The total study duration is 24 weeks, including treatment and follow-up, to evaluate both safety and visual outcomes.

A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)