CompletedPhase 2

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

Czechia, Poland, Slovakia99 participantsStarted 2022-11-22

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level

Timeframe: 42 days after first administration

Trial details

NCT IDNCT05637255

SponsorSylentis, S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-19

View on ClinicalTrials.gov More Wet Macular Degeneration trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.