NCT05637255

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2022

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

November 16, 2022

Last Update Submit

April 6, 2026

Conditions

Macular DegenerationWet Macular DegenerationNeovascular Age-related Macular Degeneration

Keywords

siRNAoligonucleotide

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • 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

    42 days after first administration

  • Change from Screening on leakage area on Day 42 after last instillation of the assigned

    43 days after first administration

  • +2 more secondary outcomes

Study Arms (3)

SYL1801 ophthalmic solution Low Dose once daily

EXPERIMENTAL

42 treatment days

Drug: SYL1801

SYL1801 ophthalmic solution Middle Dose once daily

EXPERIMENTAL

42 treatment days

Drug: SYL1801

SYL1801 ophthalmic solution High Dose once daily

EXPERIMENTAL

42 treatment days

Drug: SYL1801

Interventions

SYL1801DRUG

1 drop in the eligible eye

SYL1801 ophthalmic solution High Dose once dailySYL1801 ophthalmic solution Low Dose once dailySYL1801 ophthalmic solution Middle Dose once daily

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

SYL1801 Investigative Site

Brno, 62500, Czechia

Location

SYL1801 Investigative Site

Chomutov, 43001, Czechia

Location

SYL1801 Investigative Site

Frýdek-Místek, 738 01, Czechia

Location

SYL1801 Investigative Site

Kyjov, 69701, Czechia

Location

SYL1801 Investigative Site

Liberec, 46063, Czechia

Location

SYL1801 Investigative Site

Ostrava, 70200, Czechia

Location

SYL1801 Investigative Site

Prague, 14000, Czechia

Location

SYL1801 Investigative Site

Prague, 17000, Czechia

Location

SYL1801 Investigative Site

Gdansk, 80-809, Poland

Location

SYL1801 Investigative Site

Krakow, 31-070, Poland

Location

SYL1801 Investigative Site

Rzeszów, 35-017, Poland

Location

SYL1801 Investigative Site

Warsaw, 01-258, Poland

Location

SYL1801 Investigative Site

Bratislava, 85107, Slovakia

Location

SYL1801 Investigative Site

Košice, 04011, Slovakia

Location

SYL1801 Investigative Site

Poprad, 05801, Slovakia

Location

SYL1801 Investigative Site

Žilina, Slovakia

Location

MeSH Terms

Conditions

Wet Macular DegenerationMacular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 5, 2022

Study Start

November 22, 2022

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CZ(8)PL(4)SL(4)