A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Drug: Diluent
- Registration Number
- NCT06660667
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part I - SAR402663 open-label (OL) SAR402663 Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants. Part I - SAR402663 open-label (OL) Diluent Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants. Part II - SAR402663 Dose A SAR402663 Participants will receive a single dose of SAR402663 on Day 1. Part II - SAR402663 Dose A Diluent Participants will receive a single dose of SAR402663 on Day 1. Part II - SAR402663 Dose B SAR402663 Participants will receive a single dose of SAR402663 on Day 1. Part II - SAR402663 Dose B Diluent Participants will receive a single dose of SAR402663 on Day 1.
- Primary Outcome Measures
Name Time Method Incidence and severity of ocular treatment emergent adverse event (TEAEs) Day 1 to Week 52 Incidence and severity of ocular treatment emergent serious adverse event (TESAEs) Day 1 to Week 52 Incidence and severity of non-ocular TEAEs Day 1 to Week 52 Incidence and severity of non-ocular TESAEs Day 1 to Week 52 Number of participants with any clinically significant changes in laboratory variables Day 1 to Week 52 Number of participants with any clinically significant changes in vital signs Day 1 to Week 52
- Secondary Outcome Measures
Name Time Method Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy Day 1 to Week 52 and Week 8 to Week 52 Annualized injection rates of anti-VEGF therapy Day 1 to Week 52 Change from baseline in BCVA using the ETDRS letter score Baseline, Week 52 Visual function of the study eye was assessed at a distance of 4 meters using the best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score. BCVA scale range is 0 (worst score) to 100 (best score).
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline Baseline, Week 52 Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT) Baseline, Week 52
Trial Locations
- Locations (9)
Site # 8400023
🇺🇸Beverly Hills, California, United States
Site # 8400017
🇺🇸Eugene, Oregon, United States
Site # 8400021
🇺🇸Reno, Nevada, United States
Site # 8400018
🇺🇸Germantown, Tennessee, United States
Site # 8400011
🇺🇸Phoenix, Arizona, United States
Site # 8400006
🇺🇸Dallas, Texas, United States
Site # 8400004
🇺🇸Gainesville, Florida, United States
Site # 8400005
🇺🇸Lemont, Illinois, United States
Site # 8400015
🇺🇸Austin, Texas, United States