drugset / Trial / NCT07695207

Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy

NCT07695207

Phase 3 Recruiting 266 enrolled SANGMYUNG innovation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of SMZ1 tablets in combination with Ranibizumab compared with placebo in combination with Ranibizumab in subjects with neovascular (wet) age-related macular degeneration (nAMD) without polypoidal choroidal vasculopathy (PCV). The primary objective is to demonstrate the superiority of SMZ1 tablets over placebo with respect to improvement in best-corrected visual acuity at Month 12.

Timeline

Start
2025-09-15
Primary completion
2027-12
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject SMZ1 Unknown
Background Ranibizumab Monoclonal antibody