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

Investigating a Treatment for Neovascular Age-related Macular Degeneration

Recruiting
50 years - 90 years
All
Phase 1/2
66 participants needed
9 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 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.

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
  • Currently receiving anti-VEGF treatment in the study eye
  • Demonstrated a response to aflibercept in the pre-treatment period

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
  • Use of ocular corticosteroids in the 3 months prior to screening
  • 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.

Updated on 04 Apr 2025. Study ID: NCT06660667

This study investigates the safety and effects of an investigational medication given as a one-time injection into one eye for people with neovascular age-related macular degeneration (nAMD). Neovascular age-related macular degeneration is a condition where abnormal blood vessels grow under the retina, leading to vision loss. The study is conducted in two parts. In the first part, different dose levels of the investigational medication will be tested to find the best dose. In the second part, participants will be randomly assigned to receive one of two selected doses from the first part, without knowing which dose they receive.

Participants will receive a single injection of the investigational medication in one eye. After the injection, they will have regular check-ups over the course of 12 months to monitor their safety and how well the treatment is working. After this year, participants will continue to be followed up for safety and the lasting effects of the treatment for up to five years. This extended follow-up is to ensure the long-term safety and effectiveness of the investigational medication.

  • Who can participate: Adults aged 50 to 90 years with neovascular age-related macular degeneration who are currently receiving anti-VEGF treatment and have shown a response to aflibercept may participate. Participants must have specific vision levels in the study eye.
  • Study details: Participants will receive a one-time injection of an investigational medication into one eye. They will have regular assessments for one year to monitor safety and effectiveness, followed by long-term follow-up for up to five years.
  • Study Timelines: The study will last 12 months, with an extended follow-up through Year 5.

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