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

Sylentis, S.A.90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Wet Macular Degeneration Neovascular Age-related Macular Degeneration Macular Degeneration

Interventions

SYL1801DRUG

1 drop in the eligible eye

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

RECRUITING

SYL1801 Investigative Site

Chomutov, Czechia

Outcomes

Primary Outcomes

Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level

ETDRS chart

Time frame: 42 days after first administration

Secondary Outcomes

Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level

ETDRS chart

Time frame: 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

Time frame: Through study completion, up to 42 days

Proportion of subjects within each cohort who needed rescue medication at any point of the study

Time frame: 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)

Time frame: 42 days after first administration

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

Fluorescein Angiography

Time frame: 43 days after first administration

Change from Baseline on intraocular pressure (IOP)

Tonometry

Time frame: 42 days after first administration

Adverse Event Evaluation

Time frame: Through study completion, up to 42 days

Central Contacts

Regulatory Affairs Department

CONTACT

918047667 info@sylentis.com

Data from ClinicalTrials.gov

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