One-time treatment for 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
This study is testing a one-time injection to see if it can safely improve vision in adults with a type of age-related macular degeneration.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 18 sites (Phoenix, Arizona and 17 other locations) |
| Trial ID | NCT06660667 on ClinicalTrials.gov |
What this trial studies
This multicenter Phase 1/Phase 2 study evaluates the safety and efficacy of a single intravitreal dose of SAR402663 in adults with neovascular age-related macular degeneration. Participants will be enrolled in two parts: Part I focuses on dose escalation with multiple cohorts, while Part II involves randomization to one of two selected doses based on earlier results. Following treatment, participants will undergo regular assessments for 12 months, with an extended follow-up phase lasting up to five years to evaluate safety and clinical activity durability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 90 with a diagnosis of macular neovascularization secondary to age-related macular degeneration who are currently receiving anti-VEGF treatment.
Not a fit: Patients with conditions that may prevent visual acuity improvement or those with a history of active ocular infections or uncontrolled glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients suffering from neovascular age-related macular degeneration.
How similar studies have performed: Other studies have shown promise with similar approaches in treating neovascular age-related macular degeneration, but this specific treatment is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 17 other locations
- Site # 8400011 — Phoenix, Arizona, United States (Recruiting)
- Site # 8400028 — Scottsdale, Arizona, United States (Recruiting)
- Site # 8400023 — Beverly Hills, California, United States (Recruiting)
- Site # 8400004 — Gainesville, Florida, United States (Recruiting)
- Site # 8400002 — St. Petersburg, Florida, United States (Recruiting)
- Site # 8400010 — Augusta, Georgia, United States (Recruiting)
- Site # 8400005 — Lemont, Illinois, United States (Recruiting)
- Site # 8400003 — Hagerstown, Maryland, United States (Recruiting)
- Site # 8400009 — Boston, Massachusetts, United States (Recruiting)
- Site # 8400021 — Reno, Nevada, United States (Recruiting)
- Site # 8400017 — Eugene, Oregon, United States (Recruiting)
- Site # 8400016 — Ladson, South Carolina, United States (Recruiting)
- Site # 8400018 — Germantown, Tennessee, United States (Recruiting)
- Site # 8400008 — Abilene, Texas, United States (Recruiting)
- Site # 8400015 — Austin, Texas, United States (Recruiting)
- Site # 8400007 — Austin, Texas, United States (Recruiting)
- Site # 8400006 — Dallas, Texas, United States (Recruiting)
- Site # 8400030 — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.