Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration
Conditions
Keywords
siRNA, oligonucleotide
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.
Interventions
DRUGSYL1801
1 drop in the eligible eye
Sponsors
Sylentis, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level | 42 days after first administration | ETDRS chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level | 42 days after first administration | ETDRS chart |
| Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level | Through study completion, up to 42 days | ETDRS chart |
| 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 | 42 days after first administration | Optical Coherence Tomography Angiography (OCTA) |
| Change from Screening on leakage area on Day 42 after last instillation of the assigned | 43 days after first administration | Fluorescein Angiography |
| Change from Baseline on intraocular pressure (IOP) | 42 days after first administration | Tonometry |
| Adverse Event Evaluation | Through study completion, up to 42 days | — |
Countries
Czechia, Poland, Slovakia
Outcome results
None listed