A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients W… (NCT05637255) | Clinical Trial Compass
CompletedPhase 2
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
Czechia99 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 range50 Years – 85 Years
SexALL
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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
What they're measuring
1
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level