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NCT Number: NCT07695207

Safety and Efficacy Evaluation of SMZ1 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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

SMZ1

Drug
  • Loading Phase (3 months): SMZ1 BID and Ranibizumab Monthly injection;
  • PRN Phase (9 months): SMZ1 BID and Ranibizumab PRN injection

SMZ1 Placebo

Drug
  • Loading Phase (3 months): SMZ1 Placebo BID and Ranibizumab monthly injection;
  • PRN Phase (9 months): SMZ1 Placebo BID and Ranibizumab PRN injection

Primary outcomes

  1. Best corrected visual acuity (BCVA) at Month 12

    Time frame: 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

Secondary outcomes

  1. Monthly BCVA

    Time frame: Monthly for 11 months

    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

  2. Central retinal thickness (CRT) every three months

    Time frame: Month 3, 6, and 12

    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)

  3. Ranibizumab retreatment

    Time frame: Through Month 4 and 12

    Number of Ranibizumab retreatment through Month 4 and 12, following the Ranibizumab loading phase of 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nahyun Kang, Ph.D

CONTACT

[email protected]

+82 2-3489-6298

Sponsors and collaborators

Lead sponsor

SANGMYUNG innovation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.