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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637255
• Other study ID #: SYL1801_II
• Secondary ID: 2022-000214-34
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: January 2023
• Source: Sylentis, S.A.
• Contact: Regulatory Affairs Department
• Phone: 918047667
• Email: info[@]sylentis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 22, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• SYL1801
1 drop in the eligible eye

Locations

Country	Name	City	State
Czechia	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	Praha
Czechia	SYL1801 Investigative Site	Praha
Poland	SYL1801 Investigative Site	Gdansk
Poland	SYL1801 Investigative Site	Kraków
Poland	SYL1801 Investigative Site	Rzeszów
Poland	SYL1801 Investigative Site	Warsaw
Slovakia	SYL1801 Investigative Site	Žilina
Slovakia	SYL1801 Investigative Site	Bratislava
Slovakia	SYL1801 Investigative Site	Košice
Slovakia	SYL1801 Investigative Site	Poprad

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of subjects within each cohort who needed rescue medication at any point of the study		Through study completion, up to 42 days
Secondary	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
Secondary	Change from Screening on leakage area on Day 42 after last instillation of the assigned	Fluorescein Angiography	43 days after first administration
Secondary	Change from Baseline on intraocular pressure (IOP)	Tonometry	42 days after first administration
Secondary	Adverse Event Evaluation		Through study completion, up to 42 days