NCT05637255
Completed
Phase 2
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
Sylentis, S.A.17 sites in 3 countries99 target enrollmentNovember 22, 2022
Overview
- Phase
- Phase 2
- Intervention
- SYL1801
- Conditions
- Wet Macular Degeneration
- Sponsor
- Sylentis, S.A.
- Enrollment
- 99
- Locations
- 17
- Primary Endpoint
- Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
- Status
- Completed
- Last Updated
- 19 days ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
SYL1801 ophthalmic solution Low Dose once daily
42 treatment days
Intervention: SYL1801
SYL1801 ophthalmic solution Middle Dose once daily
42 treatment days
Intervention: SYL1801
SYL1801 ophthalmic solution High Dose once daily
42 treatment days
Intervention: SYL1801
Outcomes
Primary Outcomes
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
Time Frame: 42 days after first administration
ETDRS chart
Secondary Outcomes
- 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)
- Change from Baseline on intraocular pressure (IOP)(42 days after first administration)
- 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)
- 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)
- Change from Baseline on flow area on Day 42 after last instillation of the assigned(42 days after first administration)
- Adverse Event Evaluation(Through study completion, up to 42 days)
Study Sites (17)
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