A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
Phase 2
Recruiting
- Conditions
- Macular DegenerationWet Macular DegenerationNeovascular Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT05637255
- Lead Sponsor
- Sylentis, S.A.
- Brief Summary
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Signed informed consent
- Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD
- Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening
- Intraretinal or subretinal fluid
- Central Subfield Thickness > 300 µm
Exclusion Criteria
- Pregnant or breastfeeding females or those with a positive pregnancy test.
- Females of childbearing potential who will not use a medically acceptable contraceptive method
- Current, previous chronic or recurrent condition according to the investigator's judgement.
- Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications
- Concurrent disease in the study eye
- Previous treatment with systemic anti-Vascular Endothelial Growing Factor (Anti-VEGF) drugs or pro-VEGF treatments
- Concurrent disease in the study eye, other than AMD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SYL1801 ophthalmic solution Low Dose once daily SYL1801 42 treatment days SYL1801 ophthalmic solution Middle Dose once daily SYL1801 42 treatment days SYL1801 ophthalmic solution High Dose once daily SYL1801 42 treatment days
- Primary Outcome Measures
Name Time Method Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level 42 days after first administration ETDRS chart
- Secondary Outcome Measures
Name Time Method Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level 42 days after first administration ETDRS chart
Change from Baseline on intraocular pressure (IOP) 42 days after first administration Tonometry
Proportion of subjects within each cohort who needed rescue medication at any point of the study Through study completion, up to 42 days Change from Screening on leakage area on Day 42 after last instillation of the assigned 43 days after first administration Fluorescein Angiography
Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level Through study completion, up to 42 days ETDRS chart
Change from Baseline on flow area on Day 42 after last instillation of the assigned 42 days after first administration Optical Coherence Tomography Angiography (OCTA)
Adverse Event Evaluation Through study completion, up to 42 days
Trial Locations
- Locations (1)
SYL1801 Investigative Site
🇸🇰Žilina, Slovakia
SYL1801 Investigative Site🇸🇰Žilina, SlovakiaRegulatory Affairs DepartmentContactinfo@sylentis.comAffairs DepartmentContactinfo@sylentis.comRegulatory affairs DepartmentContactinfo@sylentis.com