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

Sanofi

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Biological: SAR402663; Drug: Diluent

Study type: Interventional

Funder types: Industry

Identifiers

NCT06660667

U1111-1299-1827 (Registry Identifier)

DFI17940

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

66 participants in 3 patient groups

Part I - SAR402663 open-label (OL)

Experimental group

Description:

Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.

Treatment:

Drug: Diluent

Biological: SAR402663

Part II - SAR402663 Dose A

Experimental group

Description:

Participants will receive a single dose of SAR402663 on Day 1.

Treatment:

Drug: Diluent

Biological: SAR402663

Part II - SAR402663 Dose B

Experimental group

Description:

Participants will receive a single dose of SAR402663 on Day 1.

Treatment:

Drug: Diluent

Biological: SAR402663