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

NCT07695207 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy

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

Sponsors & Collaborators

  • SANGMYUNG innovation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695207 on ClinicalTrials.gov