Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Conditions
Keywords
SMZ1-301
Brief 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). 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.
Interventions
DRUGSMZ1
* Loading Phase (3 months): SMZ1 BID and Ranibizumab Monthly injection; * PRN Phase (9 months): SMZ1 BID and Ranibizumab PRN injection
DRUGSMZ1 Placebo
* Loading Phase (3 months): SMZ1 Placebo BID and Ranibizumab monthly injection; * PRN Phase (9 months): SMZ1 Placebo BID and Ranibizumab PRN injection
Sponsors
SANGMYUNG innovation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity (BCVA) at Month 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Monthly BCVA | 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 |
| Central retinal thickness (CRT) every three months | 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) |
| Ranibizumab retreatment | Through Month 4 and 12 | Number of Ranibizumab retreatment through Month 4 and 12, following the Ranibizumab loading phase of 3 months |
Countries
South Korea
Contacts
CONTACTNahyun Kang, Ph.D
Outcome results
None listed