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

Evaluating the Safety and Efficacy of One-time Intravitreal SAR402663 for Neovascular Age-related Macular Degeneration

Recruiting
50 years - 90 years
All
Phase 1/2
66 participants needed
18 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neovascular Age-related Macular Degeneration
  • Age: 50 years - 90 years
  • Gender: All

Inclusion Criteria:

  • Between 50 and 90 years of age
  • Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
  • Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
  • Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
  • Demonstrated a response to anti-VEGF treatment

Exclusion Criteria:

  • Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
  • History of active ocular infection in the study eye in 6 months prior to screening
  • Active uncontrolled glaucoma in the study eye
  • History of uveitis in either eye
  • Current use of ocular corticosteroids in the study eye
  • Previous gene therapy
  • Any significant poorly controlled illness that would preclude study compliance and follow up

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

This study investigates neovascular age-related macular degeneration. It looks at the safety and effectiveness of a one-time dose of an investigational medication given as an eye injection.

The purpose of this study is to evaluate how safe the investigational medication is and how well it works for this condition. It checks if the treatment can be tolerated by participants and if it has the intended effects.

  • Who can participate: Adults aged 50 to 90 years with neovascular age-related macular degeneration can participate if they have previous or current use of anti-VEGF treatment and a specific range of visual acuity in the study eye.
  • Study details: Participants will receive a one-time eye injection of the investigational medication. An inactive substance, called a placebo, looks like the investigational medicine but does not contain any medicine, and may be used for comparison.
  • Study timelines: The study will last 12 months.
Updated on 19 Nov 2025. Study ID: NCT06660667

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