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

Keywords

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