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NCT06660667 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
A Phase 1 study of Neovascular Age-related Macular Degeneration, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 18
- Study locations
NCT06660667: Recruiting Phase 1 study of Neovascular Age-related Macular Degeneration, sponsored by Sanofi.
NCT06660667 is a Phase 1 study of Neovascular Age-related Macular Degeneration that is actively recruiting participants, run by Sanofi. The registered enrollment target is 66 participants, below the 407-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (84% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06660667, a Phase 1 study of Neovascular Age-related Macular Degeneration, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 18
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL SAR402663
- DRUG Diluent
Study Locations (18)
Texas
- Site # 8400008 - Abilene
- Site # 8400015 - Austin
- Site # 8400007 - Austin
- Site # 8400006 - Dallas
- Site # 8400030 - San Antonio
Arizona
- Site # 8400011 - Phoenix
- Site # 8400028 - Scottsdale
Florida
- Site # 8400004 - Gainesville
- Site # 8400002 - St. Petersburg
California
- Site # 8400023 - Beverly Hills
Georgia
- Site # 8400010 - Augusta
Illinois
- Site # 8400005 - Lemont
Maryland
- Site # 8400003 - Hagerstown
Massachusetts
- Site # 8400009 - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2031-06-30 |
| Phase | Phase 1 |
What NCT06660667 shows while recruiting
NCT06660667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 407-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which SAR402663 is the first listed.
NCT06660667 lists 18 locations in 12 states (Texas, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT06660667 about?
NCT06660667 is a clinical study titled "A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration". 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 l...
What is the current status of trial NCT06660667?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2024-11-21. Estimated completion is 2031-06-30.
What conditions does trial NCT06660667 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT06660667?
The interventions under investigation include: SAR402663 (BIOLOGICAL), Diluent (DRUG).
Who is sponsoring clinical trial NCT06660667?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06660667 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06660667's enrollment target sits among peer trials
66 19th of 33 higher than 15 of 33 other Neovascular Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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