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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration

Intervention / Treatment
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* Drug: SYL1801


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYL1801 ophthalmic solution Low Dose once daily<br>42 treatment days | Drug: SYL1801<br>* 1 drop in the eligible eye<br>|
| Experimental: SYL1801 ophthalmic solution Middle Dose once daily<br>42 treatment days | Drug: SYL1801<br>* 1 drop in the eligible eye<br>|
| Experimental: SYL1801 ophthalmic solution High Dose once daily<br>42 treatment days | Drug: SYL1801<br>* 1 drop in the eligible eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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siRNA, oligonucleotide