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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) | Clinical Trials | Clareo Health

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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)

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

NCT05637255•Sylentis, S.A.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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

Locations (16)

SYL1801 Investigative Site

Brno, Czechia

SYL1801 Investigative Site

Chomutov, Czechia

SYL1801 Investigative Site

Frýdek-Místek, Czechia

SYL1801 Investigative Site

Kyjov, Czechia

SYL1801 Investigative Site

Liberec, Czechia

SYL1801 Investigative Site

Ostrava, Czechia

SYL1801 Investigative Site

Prague, Czechia

SYL1801 Investigative Site

Prague, Czechia

SYL1801 Investigative Site

Gdansk, Poland

SYL1801 Investigative Site

Krakow, Poland

Key Dates

Start Date

November 22, 2022

Primary Completion Date

July 22, 2023

Completion Date

November 22, 2023

Last Updated

January 26, 2023

Enrollment

ESTIMATED participants

Conditions

Wet Macular DegenerationNeovascular Age-related Macular DegenerationMacular Degeneration

Interventions

SYL1801

DRUG

Contacts

Regulatory Affairs Department

CONTACT

918047667 info@sylentis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

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