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

Phase 2
Recruiting
Conditions
Macular Degeneration
Wet Macular Degeneration
Neovascular Age-related Macular Degeneration
Interventions
Registration Number
NCT05637255
Lead Sponsor
Sylentis, S.A.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SYL1801 ophthalmic solution Low Dose once dailySYL180142 treatment days
SYL1801 ophthalmic solution Middle Dose once dailySYL180142 treatment days
SYL1801 ophthalmic solution High Dose once dailySYL180142 treatment days
Primary Outcome Measures
NameTimeMethod
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level42 days after first administration

ETDRS chart

Secondary Outcome Measures
NameTimeMethod
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level42 days after first administration

ETDRS chart

Change from Baseline on intraocular pressure (IOP)42 days after first administration

Tonometry

Proportion of subjects within each cohort who needed rescue medication at any point of the studyThrough study completion, up to 42 days
Change from Screening on leakage area on Day 42 after last instillation of the assigned43 days after first administration

Fluorescein Angiography

Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose levelThrough study completion, up to 42 days

ETDRS chart

Change from Baseline on flow area on Day 42 after last instillation of the assigned42 days after first administration

Optical Coherence Tomography Angiography (OCTA)

Adverse Event EvaluationThrough study completion, up to 42 days

Trial Locations

Locations (1)

SYL1801 Investigative Site

🇸🇰

Žilina, Slovakia

SYL1801 Investigative Site
🇸🇰Žilina, Slovakia
Regulatory Affairs Department
Contact
info@sylentis.com
Affairs Department
Contact
info@sylentis.com
Regulatory affairs Department
Contact
info@sylentis.com

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