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Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Sponsor: SANGMYUNG innovation
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.
Official title: A 12-month, Randomization, Double-blind, Placebo-controlled, Parallel, Multicenter-Phase 3 Trial to Evaluate the Safety and Efficacy of SMZ1 Tablet in Combination With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2025-09-15
Completion Date
2028-07
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
SMZ1
* Loading Phase (3 months): SMZ1 BID and Ranibizumab Monthly injection; * PRN Phase (9 months): SMZ1 BID and Ranibizumab PRN injection
SMZ1 Placebo
* Loading Phase (3 months): SMZ1 Placebo BID and Ranibizumab monthly injection; * PRN Phase (9 months): SMZ1 Placebo BID and Ranibizumab PRN injection
Locations (1)
Kyung Hee University Hospital
Seoul, Seoul, South Korea