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RECRUITING
NCT07695207
PHASE3

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

Sponsor: SANGMYUNG innovation

View on ClinicalTrials.gov

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

Interventions

DRUG

SMZ1

* Loading Phase (3 months): SMZ1 BID and Ranibizumab Monthly injection; * PRN Phase (9 months): SMZ1 BID and Ranibizumab PRN injection

DRUG

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