NCT07695207RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 266 (estimated)
First submitted: 26 Jun 2026
Start date: 15 Sept 2025
Primary completion date: Dec 2027
Lead sponsor: SANGMYUNG innovation
Diseases: Macular degeneration
NCT number: NCT07695207

What you commit to

Study type: Interventional · Phase 3
Planned participants: 266
From 15 Sept 2025 to the primary completion date, Dec 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

A study eye with vitreous hemorrhage occurring within 1 month prior to the Screening Visit

Other illness

History of ocular treatment, systemic therapies, or surgical procedures, such as photodynamic therapy (PDT) and laser photocoagulation, for the treatment of wet nAMD (supplements and vitamins excluded)
History of anti-VEGF treatment (e.g., ranibizumab, bevacizumab, aflibercept 2mg, or biosimilars) or combination therapy in the study eye for the treatment of wet nAMD

Other

A study eye with scarring or fibrosis covering more than 50% of the total lesion area
A study eye with intraocular pressure (IOP) ≥ 25mmHg, including glaucoma with IOP ≥ 25mmHg despite medical treatment
A study eye with a total lesion area (including vessels, scar tissue, and neovascularization) greater than 12 optic-disk areas (\>30.5mm2), as measured by FAG

Who the study is looking for

50 years of age or older
A study eye satisfying all of the following criteria after screening
- ① Active\* submacular choroidal neovascularization due to nAMD confirmed by fluorescein angiography (FAG) and optical coherence tomography (OCT)
- \*Fluorescence leakage confirmed via FAG and intraretinal or subretinal fluid confirmed via OCT
- ② Absence of active polypoidal lesions due to polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA)
A study eye with fibrosis covering less than 50% of the total lesion area
A study eye with ETDRS best corrected visual acuity (BCVA) score range of 73-24 at a distance of 4m (equivalent to 20/40-20/320 of Snellen)
A study eye with a neovascular lesion area of less than 12 optic-disk areas (For an optic nerve head diameter set to 1.8mm, the corresponding optic-disk area is 2.45mm2)
Provided written informed consent voluntarily after receiving a full explanation of the clinical trial.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Kyung Hee University Hospital Coordinator of this site? Confirm its status	Seoul	South Korea	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.