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Search / Trial NCT05637255

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

Launched by SYLENTIS, S.A. · Nov 23, 2022

Trial Information

Current as of January 13, 2025

Unknown status

Keywords

Si Rna Oligonucleotide

ClinConnect Summary

This clinical trial is looking at a new eye drop treatment called SYL1801 for people with wet macular degeneration, also known as neovascular age-related macular degeneration (AMD). The main goal is to find out how safe the eye drops are and how well they can improve vision. Researchers will compare three different doses of SYL1801 to see which one works best. The trial is currently recruiting participants aged 18 to 75 who have specific eye conditions related to AMD, such as fluid in the retina and certain levels of vision.

If you decide to participate, you will need to sign a consent form and meet certain health criteria, like having active AMD and a specific range of visual acuity. You cannot participate if you are pregnant, have certain eye diseases, or have received specific prior treatments for AMD. Participants can expect to receive either SYL1801 or a placebo (a non-active treatment) in a double-masked manner, meaning neither you nor the researchers will know which treatment you are receiving. This helps ensure the results are unbiased. Overall, this study aims to provide valuable information that could lead to better treatments for AMD in the future.

Gender

ALL

Eligibility criteria

  • 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

About Sylentis, S.A.

Sylentis, S.A. is a biotechnology company focused on the development of innovative RNA-based therapeutics for the treatment of prevalent diseases. With a strong commitment to advancing the field of genetic medicine, Sylentis specializes in designing and delivering small interfering RNA (siRNA) treatments that target specific genes involved in various pathologies. The company’s research and clinical initiatives aim to improve patient outcomes through precision medicine, leveraging cutting-edge technologies and a robust pipeline of drug candidates. Sylentis is dedicated to collaboration with academic and industry partners to accelerate the translation of its discoveries into effective therapies.

Locations

Praha, , Czechia

žilina, , Slovakia

Brno, , Czechia

Chomutov, , Czechia

Frýdek Místek, , Czechia

Kyjov, , Czechia

Liberec, , Czechia

Ostrava, , Czechia

Gdansk, , Poland

Kraków, , Poland

Rzeszów, , Poland

Warsaw, , Poland

Bratislava, , Slovakia

Košice, , Slovakia

Poprad, , Slovakia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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