Clinical trial NCT05637255: A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
Official title: A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wet Macular Degeneration
Neovascular Age-related Macular Degeneration
Macular Degeneration
Keywords: siRNA
oligonucleotide
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
timeFrame: 42 days after first administration
Secondary outcomes:
measure: Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level
timeFrame: 42 days after first administration
measure: Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level
timeFrame: Through study completion, up to 42 days
measure: Proportion of subjects within each cohort who needed rescue medication at any point of the study
timeFrame: Through study completion, up to 42 days
measure: Change from Baseline on flow area on Day 42 after last instillation of the assigned
timeFrame: 42 days after first administration
measure: Change from Screening on leakage area on Day 42 after last instillation of the assigned
timeFrame: 43 days after first administration
measure: Change from Baseline on intraocular pressure (IOP)
timeFrame: 42 days after first administration
measure: Adverse Event Evaluation
timeFrame: Through study completion, up to 42 days
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: SYL1801 Investigative Site
city: Chomutov
country: Czechia
facility: SYL1801 Investigative Site
city: Frýdek-Místek
country: Czechia
facility: SYL1801 Investigative Site
city: Kyjov
country: Czechia
facility: SYL1801 Investigative Site
city: Liberec
country: Czechia
facility: SYL1801 Investigative Site
city: Ostrava
country: Czechia
facility: SYL1801 Investigative Site
city: Praha
country: Czechia
facility: SYL1801 Investigative Site
city: Praha
country: Czechia
facility: SYL1801 Investigative Site
city: Gdansk
country: Poland
facility: SYL1801 Investigative Site
city: Kraków
country: Poland
facility: SYL1801 Investigative Site
city: Rzeszów
country: Poland
facility: SYL1801 Investigative Site
city: Warsaw
country: Poland
facility: SYL1801 Investigative Site
city: Bratislava
country: Slovakia
facility: SYL1801 Investigative Site
city: Košice
country: Slovakia
facility: SYL1801 Investigative Site
city: Poprad
country: Slovakia
facility: SYL1801 Investigative Site
city: Žilina
country: Slovakia
facility: SYL1801 Investigative Site
Study officials:
References: