A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD

SYL1801_II

The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.

2022-11-22

2023-07-22

2023-11-22

Recruiting

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-01-26