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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000214-34 | EudraCT Number |
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The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYL1801 ophthalmic solution Low Dose once daily | Experimental | 42 treatment days |
|
| SYL1801 ophthalmic solution Middle Dose once daily | Experimental | 42 treatment days |
|
| SYL1801 ophthalmic solution High Dose once daily | Experimental | 42 treatment days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYL1801 | Drug | 1 drop in the eligible eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level | ETDRS chart | 42 days after first administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SYL1801 Investigative Site | Brno | 62500 | Czechia | |||
| SYL1801 Investigative Site |
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ETDRS chart |
| Through study completion, up to 42 days |
| Proportion of subjects within each cohort who needed rescue medication at any point of the study | 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) | 42 days after first administration |
| Change from Screening on leakage area on Day 42 after last instillation of the assigned | Fluorescein Angiography | 43 days after first administration |
| Change from Baseline on intraocular pressure (IOP) | Tonometry | 42 days after first administration |
| Adverse Event Evaluation | Through study completion, up to 42 days |
| Chomutov |
| 43001 |
| Czechia |
| SYL1801 Investigative Site | Frýdek-Místek | 738 01 | Czechia |
| SYL1801 Investigative Site | Kyjov | 69701 | Czechia |
| SYL1801 Investigative Site | Liberec | 46063 | Czechia |
| SYL1801 Investigative Site | Ostrava | 70200 | Czechia |
| SYL1801 Investigative Site | Prague | 14000 | Czechia |
| SYL1801 Investigative Site | Prague | 17000 | Czechia |
| SYL1801 Investigative Site | Gdansk | 80-809 | Poland |
| SYL1801 Investigative Site | Krakow | 31-070 | Poland |
| SYL1801 Investigative Site | Rzeszów | 35-017 | Poland |
| SYL1801 Investigative Site | Warsaw | 01-258 | Poland |
| SYL1801 Investigative Site | Bratislava | 85107 | Slovakia |
| SYL1801 Investigative Site | Košice | 04011 | Slovakia |
| SYL1801 Investigative Site | Poprad | 05801 | Slovakia |
| SYL1801 Investigative Site | Žilina | Slovakia |
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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