A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
NCT ID: NCT05637255
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2022-11-22
2023-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SYL1801 ophthalmic solution Low Dose once daily
42 treatment days
SYL1801
1 drop in the eligible eye
SYL1801 ophthalmic solution Middle Dose once daily
42 treatment days
SYL1801
1 drop in the eligible eye
SYL1801 ophthalmic solution High Dose once daily
42 treatment days
SYL1801
1 drop in the eligible eye
Interventions
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SYL1801
1 drop in the eligible eye
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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Sylentis, S.A.
INDUSTRY
Responsible Party
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Locations
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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
SYL1801 Investigative Site
Rzeszów, , Poland
SYL1801 Investigative Site
Warsaw, , Poland
SYL1801 Investigative Site
Bratislava, , Slovakia
SYL1801 Investigative Site
Košice, , Slovakia
SYL1801 Investigative Site
Poprad, , Slovakia
SYL1801 Investigative Site
Žilina, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2022-000214-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SYL1801_II
Identifier Type: -
Identifier Source: org_study_id
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