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

Last updated: January 25, 2023
Sponsor: Sylentis, S.A.
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

N/A

Clinical Study ID

NCT05637255
SYL1801_II
2022-000214-34
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breastfeeding females or those with a positive pregnancy test.
  • Females of childbearing potential who will not use a medically acceptablecontraceptive method
  • Current, previous chronic or recurrent condition according to the investigator'sjudgement.
  • Concomitant treatment or prior ocular procedure or surgery, or alteration of the doseof 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

Study Design

Total Participants: 90
Study Start date:
November 22, 2022
Estimated Completion Date:
November 22, 2023

Connect with a study center

  • SYL1801 Investigative Site

    Brno, 62500
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Chomutov, 43001
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Frýdek-Místek, 738 01
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Kyjov, 69701
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Liberec, 46063
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Ostrava, 70200
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Praha, 17000
    Czechia

    Active - Recruiting

  • SYL1801 Investigative Site

    Gdansk, 80-809
    Poland

    Active - Recruiting

  • SYL1801 Investigative Site

    Kraków, 31-070
    Poland

    Active - Recruiting

  • SYL1801 Investigative Site

    Rzeszów, 35-017
    Poland

    Active - Recruiting

  • SYL1801 Investigative Site

    Warsaw, 01-258
    Poland

    Active - Recruiting

  • SYL1801 Investigative Site

    Bratislava, 85107
    Slovakia

    Active - Recruiting

  • SYL1801 Investigative Site

    Košice, 04011
    Slovakia

    Active - Recruiting

  • SYL1801 Investigative Site

    Poprad, 05801
    Slovakia

    Active - Recruiting

  • SYL1801 Investigative Site

    Žilina,
    Slovakia

    Active - Recruiting

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