Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
In brief
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.
Key facts
- Study ID
- NCT07695207
- Run by
- SANGMYUNG innovation
- People needed
- 266
- Starts
- 2025-09-15
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Kyung Hee University Hospital — Seoul, Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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