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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 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.

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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

Neovascular Age-related Macular Degeneration

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

713 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, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (84% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.