RecruitingPhase 3

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

South Korea266 participantsStarted 2025-09-15

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * A study eye with scarring or fibrosis covering more than 50% of the total lesion area * A study eye wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best corrected visual acuity (BCVA) at Month 12

Timeframe: Month 12

Trial details

NCT IDNCT07695207

SponsorSANGMYUNG innovation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Nahyun Kang, Ph.D

+82 2-3489-6298 nahyun.kang@sminnovation.com

View on ClinicalTrials.gov More Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy trials