SAR402663 in participants with neovascular macular degeneration
Research type
Research Study
Full title
A Phase 1/2 dose escalation and dose expansion study to evaluate the safety, tolerability, and efficacy of one-time intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration
IRAS ID
1011143
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Developpement
Clinicaltrials.gov Identifier
Research summary
Age-related macular degeneration causes significant central visual impairment. It is the leading cause of irreversible vision loss among individuals aged 60 or over in developed countries.
This study evaluates the safety, tolerability and efficacy of an experimental gene therapy named SAR402663. The gene therapy is delivered into the eye one time, with the potential to provide durable treatment. Currently approved therapies require multiple treatments with patients receiving on average, 8 injections per year. There is significant need for longer acting therapies to reduce burden on the patients as well as provide sustained VEGF inhibition to optimize clinical outcomes.
The study will include around 66 people who are aged between 50 to 90 will participate. This study is being carried out in multiple countries around the world. Participants will be on the study for around 5 years. In that time participants will have approximately 25 visits and 8 phone calls. Each participant who meets the criteria to take part will receive a single dose of SAR402663, injected into one eye. Throughout the study the participants health will be monitored and ocular images will be taken of the participants’ eye. Approved standard care injections will be provided if needed.
Sanofi-Aventis Recherche & Developpement, is the sponsor of this study.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0061
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion