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

A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD

The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration; Wet Macular Degeneration; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: SYL1801

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • SYL1801 Investigative Site
  • Chomutov, Czechia, 43001
    • SYL1801 Investigative Site
  • Frýdek-Místek, Czechia, 738 01
    • SYL1801 Investigative Site
  • Kyjov, Czechia, 69701
    • SYL1801 Investigative Site
  • Liberec, Czechia, 46063
    • SYL1801 Investigative Site
  • Ostrava, Czechia, 70200
    • SYL1801 Investigative Site
  • Prague, Czechia, 14000
    • SYL1801 Investigative Site
  • Prague, Czechia, 17000
    • SYL1801 Investigative Site
• Poland
  • Gdansk, Poland, 80-809
    • SYL1801 Investigative Site
  • Krakow, Poland, 31-070
    • SYL1801 Investigative Site
  • Rzeszów, Poland, 35-017
    • SYL1801 Investigative Site
  • Warsaw, Poland, 01-258
    • SYL1801 Investigative Site
• Slovakia
  • Bratislava, Slovakia, 85107
    • SYL1801 Investigative Site
  • Košice, Slovakia, 04011
    • SYL1801 Investigative Site
  • Poprad, Slovakia, 05801
    • SYL1801 Investigative Site
  • Žilina, Slovakia
    • SYL1801 Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYL1801 ophthalmic solution Low Dose once daily; 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution Middle Dose once daily; 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution High Dose once daily; 42 treatment days	Drug: SYL1801; 1 drop in the eligible eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level	ETDRS chart	42 days after first administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level	ETDRS chart	42 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	ETDRS chart	Through study completion, up to 42 days
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 Baseline on flow area on Day 42 after last instillation of the assigned	Optical Coherence Tomography Angiography (OCTA)	42 days after first administration
Change from Screening on leakage area on Day 42 after last instillation of the assigned	Fluorescein Angiography	43 days after first administration
Change from Baseline on intraocular pressure (IOP)	Tonometry	42 days after first administration
Adverse Event Evaluation		Through study completion, up to 42 days

Collaborators and Investigators

• Sponsor: Sylentis, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: siRNA; oligonucleotide
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: SYL1801_II; 2022-000214-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No