A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Investigation of Safety and Efficacy of an Investigational Medication for Neovascular Age-related Macular Degeneration
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, 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.
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
- 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.
This study investigates the safety and effectiveness of a one-time intravitreal dose of an investigational medication in adults with neovascular age-related macular degeneration (nAMD). The study is conducted in two parts: Part I involves evaluating different dose levels in successive groups of participants, while Part II involves randomizing participants to receive one of two dose levels selected based on Part I data. In Part II, participants, investigators, and outcome assessors will not know which dose level is administered.
Participants will receive a one-time dose of the investigational medication and will undergo regular assessments over a 12-month period to monitor safety and clinical activity. After the initial assessment phase, participants will enter an extended follow-up phase to evaluate the long-term safety and effectiveness of the treatment through Year 5. This involves routine check-ups and monitoring to ensure the investigational medication's durability and safety over time.
- Who can participate: Adults aged between 50 and 90 years with neovascular age-related macular degeneration can participate. Key eligibility includes having a study eye with specific visual acuity ranges and a history of anti-VEGF treatment.
- Study details: Participants will receive a single intravitreal injection in one eye and will be monitored through regular eye assessments. The study involves two parts: dose escalation and dose expansion, with participants not knowing which dose they receive.
Find a study site near you
,
Send a message
Enter your contact details to connect with study team
Primary Contact
