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Completed

NCT Number: NCT05637255

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

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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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Neovascular Age-related Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SYL1801 Investigative Site, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYL1801

Drug

1 drop in the eligible eye

Primary outcomes

  1. Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level

    Time frame: 42 days after first administration

    ETDRS chart

Secondary outcomes

  1. Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level

    Time frame: 42 days after first administration

    ETDRS chart

  2. Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level

    Time frame: Through study completion, up to 42 days

    ETDRS chart

  3. Proportion of subjects within each cohort who needed rescue medication at any point of the study

    Time frame: Through study completion, up to 42 days

  4. Change from Baseline on flow area on Day 42 after last instillation of the assigned

    Time frame: 42 days after first administration

    Optical Coherence Tomography Angiography (OCTA)

  5. Change from Screening on leakage area on Day 42 after last instillation of the assigned

    Time frame: 43 days after first administration

    Fluorescein Angiography

  6. Change from Baseline on intraocular pressure (IOP)

    Time frame: 42 days after first administration

    Tonometry

  7. Adverse Event Evaluation

    Time frame: Through study completion, up to 42 days

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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