NCT06660667 A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
| NCT ID | NCT06660667 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sanofi |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2027-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-11-21 with a primary completion date of 2027-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT06660667 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06660667 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06660667 currently recruiting?
Yes, NCT06660667 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT06660667 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Beverly Hills, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06660667 clinical trial?
NCT06660667 is sponsored by Sanofi. The trial plans to enroll 66 participants.