A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)

• Status: Recruiting
• Trial end date: 2023-11-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sylentis, S.A.

Criteria

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