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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMZ1 Group | Experimental | SMZ1 + Ranibizumab |
|
| SMZ1 Placebo Group | Placebo Comparator | SMZ1 Placebo + Ranibizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMZ1 | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Monthly for 11 months |
| Central retinal thickness (CRT) every three months |
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Inclusion Criteria:
50 years of age or older
A study eye satisfying all of the following criteria after screening
â‘ 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
â‘¡ 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nahyun Kang, Ph.D | Contact | +82 2-3489-6298 | nahyun.kang@sminnovation.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Recruiting | Seoul | Seoul | 02447 | South Korea |
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| SMZ1 Placebo | Drug |
|
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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)
| Month 3, 6, and 12 |
| Ranibizumab retreatment | Number of Ranibizumab retreatment through Month 4 and 12, following the Ranibizumab loading phase of 3 months | Through Month 4 and 12 |