4D-150 in Patients with Neovascular (Wet) Age-Related Macular Degeneration

Last updated: November 1, 2024
Sponsor: 4D Molecular Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

4D-150 IVT

Aflibercept IVT

Clinical Study ID

NCT05197270
4D-150-C001
  • Ages > 50
  • All Genders

Study Summary

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥50 years of age

  • Diagnosed with macular CNV secondary to AMD

  • BCVA ETDRS Snellen equivalent for dose escalation between 20/32 and ~20/320, or fordose expansion and population extension between ~20/25 and20/200, for steroidoptimization between ~20/25 and ~20/640

  • Currently receiving anti-VEGF treatment in the study eye and has demonstrated aclinical response consistent with anti-VEGF activity within 12 months prior toscreening

Exclusion

Exclusion Criteria:

  • Any condition preventing visual acuity improvement in the study eye

  • Prior treatment with photodynamic therapy or retinal laser in the study eye

  • History of uveitis in either eye

  • Any other pre-existing eye conditions or surgical complications that would precludeparticipation in an interventional clinical trial or interfere with theinterpretation of study endpoints

Study Design

Total Participants: 215
Treatment Group(s): 2
Primary Treatment: 4D-150 IVT
Phase: 1/2
Study Start date:
December 09, 2021
Estimated Completion Date:
November 30, 2026

Study Description

This Phase 1/2 trial is a prospective, multicenter, Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment who have demonstrated a clinical response consistent with anti-VEGF activity. The trial consists of Dose Escalation, Dose Expansion, Steroid Optimization and Population Extension Cohorts.

After receiving one time administration of 4D-150 by intravitreal injection, subjects will undergo assessments at monthly intervals for 24 months to assess safety and efficacy outcomes. Only subjects that received 4D-150 will then enter a long-term follow-up (LTFU) period to assess long-term safety of 4D-150 gene therapy and duration of clinical activity through year 5 (60 months).

Connect with a study center

  • Emanuelli Research and Development Center, LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Barnet Delaney Perkins Eye Center

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • California Retina Consultants

    Oxnard, California 93036
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95841
    United States

    Active - Recruiting

  • Colorado Retina Associates

    Lakewood, Colorado 80288
    United States

    Active - Recruiting

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Vitreo Retinal Associates

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Eye Associates

    Melbourne, Florida 32901
    United States

    Active - Recruiting

  • Retinal Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • University Retina and Macula Associates

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Retina Partners Midwest

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Western Carolina Retinal Associates

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Verum Research, LLC

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Palmetto Retina Center, LLC

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Austin Clinical Research

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Valley Retina Institute, PA

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Pacific Northwest Retina LLC

    Bellevue, Washington 98004
    United States

    Active - Recruiting

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