Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal VasculopathyPhase 3NCT07695207
Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
A Phase 3 study testing SMZ1 in people with Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy, run by SANGMYUNG innovation at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
- What is being tested?
- SMZ1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2025to Jul 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 with vitreous hemorrhage occurring within 1 month prior to the Screening Visit
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital
Seoul, Seoul, 02447
Gyeong-suk Yeo, +82 2-958-8461, oplasik@hanmail.net
About this study
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
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
- Being tested
- SMZ1, SMZ1 Placebo
- Keywords
- SMZ1-301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMZ1Drug
- Loading Phase (3 months): SMZ1 BID and Ranibizumab Monthly injection;
- PRN Phase (9 months): SMZ1 BID and Ranibizumab PRN injection
SMZ1 PlaceboDrug
- Loading Phase (3 months): SMZ1 Placebo BID and Ranibizumab monthly injection;
- PRN Phase (9 months): SMZ1 Placebo BID and Ranibizumab PRN injection
| Study group | Role | What they receive |
|---|---|---|
| SMZ1 Group | Experimental | SMZ1 + Ranibizumab Receives: Drug: SMZ1 |
| SMZ1 Placebo Group | Placebo comparator | SMZ1 Placebo + Ranibizumab Receives: Drug: SMZ1 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) at Month 12
Change in BCVA score from baseline, at Month 12 after the administration of the investigational drug using early treatment diabetic retinopathy study (ETDRS) chart
Measured: Month 12
Secondary outcomes (3)
Monthly BCVA
Change in BCVA score from baseline, at each month after the administration of the investigational drug for 11 months (excluding Month 12) using ETDRS chart
Measured: Monthly for 11 months
Central retinal thickness (CRT) every three months
Change in CRT from the screening visit, at Month 3, 6, and 12 after the administration of the investigational drug measured with optical coherence tomography (OCT)
Measured: Month 3, 6, and 12
Ranibizumab retreatment
Number of Ranibizumab retreatment through Month 4 and 12, following the Ranibizumab loading phase of 3 months
Measured: Through Month 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SANGMYUNG innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695207
- Sponsor's protocol ID
- SMZ1-301
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No