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

Korábbi kezelés

• Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
• 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 active ocular infection in the study eye in 6 months prior to screening
• Previous gene therapy in either eye

Más betegség

• GA in the study eye caused by a disease different than AMD
• 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
• History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
• Presence of active ocular or periocular infections
• History of uveitis or scleritis in either eye
• 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 patient's potential participation in a clinical trial.

Egyéb

• Active uncontrolled glaucoma in the study eye

• 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