Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Recruiting
Phase 3
Interventional Study
Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 266 (estimated)
- Sponsor
- SANGMYUNG innovation · Industry
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About This Trial
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 improvem…
Trial Locations
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Eligibility Criteria
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 confirm…
Contacts