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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase 1/2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

SAR402663

Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection

DRUG

Diluent

Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection

Locations (18)

Site # 8400011
Phoenix, Arizona, United States
Site # 8400028
Scottsdale, Arizona, United States
Site # 8400023
Beverly Hills, California, United States
Site # 8400004
Gainesville, Florida, United States
Site # 8400002
St. Petersburg, Florida, United States
Site # 8400010
Augusta, Georgia, United States
Site # 8400005
Lemont, Illinois, United States
Site # 8400003
Hagerstown, Maryland, United States
Site # 8400009
Boston, Massachusetts, United States
Site # 8400021
Reno, Nevada, United States
Site # 8400017
Eugene, Oregon, United States
Site # 8400016
Ladson, South Carolina, United States
Site # 8400018
Germantown, Tennessee, United States
Site # 8400008
Abilene, Texas, United States
Site # 8400015
Austin, Texas, United States
Site # 8400007
Austin, Texas, United States
Site # 8400006
Dallas, Texas, United States
Site # 8400030
San Antonio, Texas, United States