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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
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 and investigators 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.
Epistemonikos ID: 0773013f7f7414968eaa6dc043aa489f85d37858
First added on: Nov 01, 2024