A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Sanofi

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Geographic Atrophy

Treatments: Drug: Sham Comparator; Drug: SAR446597

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215234

DFI18231

Details and patient eligibility

About

This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).

The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.

The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).

Enrollment: 104 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 years old or above
• Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
• Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
• Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II

Exclusion criteria

• GA in the study eye caused by a disease different than AMD
• Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
• Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
• Current or history of systemic complement targeting treatment in the past 12 months
• Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
• History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
• History of active ocular infection in the study eye in 6 months prior to screening
• Presence of active ocular or periocular infections
• Active uncontrolled glaucoma in the study eye
• History of uveitis or scleritis in either eye
• Previous gene therapy in either eye
• Any significant poorly controlled illness that would preclude study compliance and follow up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

104 participants in 4 patient groups

Part I - SAR446597 open-label (OL)

Experimental group

Description:

Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.

Treatment:

Drug: SAR446597

Part II - SAR446597 Dose A

Experimental group

Description:

Participants will receive SAR at a dose specified for each arm.

Treatment:

Drug: SAR446597

Part II - SAR446597 Dose B

Experimental group

Description:

Participants will receive SAR at a dose specified for each arm.

Treatment:

Drug: SAR446597

Part II - Sham control

Sham Comparator group

Description:

Participants will receive Sham at a dose specified for each arm.

Treatment:

Drug: Sham Comparator