A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration

This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration. Participants will be enrolled in one of 2 parts: * In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants * In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose. After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.

NCT Number	NCT06660667
Lead Sponsor	Sanofi
Conditions	Neovascular Age-related Macular Degeneration
Enrollment	66 participants
Start Date	2024-11-21
Primary Completion	2027-05-18 (estimated)
Study Completion	2031-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-16