Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Last updated: July 7, 2025
Sponsor: 4D Molecular Therapeutics
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Diabetic Retinopathy

Geographic Atrophy

Treatment

4D-150 IVT (3E10 vg/eye)

EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Clinical Study ID

NCT07064759
4D-150-C004
  • Ages > 50
  • All Genders

Study Summary

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥50 years of age at time of consent

  • MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, definedas EITHER:

  1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR

  2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD andreceived diagnosis of nAMD no more than 6 months prior to the Screening VisitAND documented evidence of anatomical improvement and visualstability/improvement in response to previous IVT anti-VEGF treatment, asdetermined by the Investigator

  • Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflectivematerial, or leakage) identified by fluorescein angiography (FA) or spectral domainoptical coherence tomography (SD-OCT) , in the study eye, at the Screening Visitconfirmed by the Reading Center

  • Demonstrated clinical response to aflibercept and functional stability in the studyeye as confirmed by the Reading Center

  • BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) inthe study eye at the Screening Visit

  • CST less than or equal to 500 microns in the study eye at screening visit, confirmedby the central reading center

Exclusion

Exclusion Criteria:

Ocular Conditions:

  • MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinalhemorrhage in the foveal central subfield (1 mm diameter)

  • History of retinal detachment in the study eye

  • History of or presence of active inflammation in either eye

  • Glaucoma or intraocular hypertension requiring more than 2 topical medications forcontrol

Ocular Treatments/Interventions:

  • Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities,other than allowed prior IVT anti-VEGF in the study eye

Systemic Conditions and Considerations:

  • Major illness or major surgical procedure in the 28 days prior to the ScreeningVisit

  • Uncontrolled blood pressure

  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization,cerebrovascular accident, transient ischemic attack within 6 months of the ScreeningVisit

  • History of autoimmune condition that may predispose to the development of uveitis

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: 4D-150 IVT (3E10 vg/eye)
Phase: 3
Study Start date:
July 01, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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