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RECRUITING Phase 1

A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration

NCT06660667 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 66 participants
Start Date 2024-11-21
Est. Completion 2031-06-30
Phase Phase 1

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06660667

The ClinicalTrials.gov registry entry for NCT06660667 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06660667 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Texas, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06660667?

The interventions under investigation include: SAR402663 (BIOLOGICAL), Diluent (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06660667?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial