Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Keywords

Macular Neovascularization Secondary to Age-Related Macular Degeneration, Age-related macular degeneration, AMD, Exudative AMD, Neovascular AMD, Exudative age-related macular degeneration, Neovascular age-related macular degeneration, Wet age-related macular degeneration, Wet macular degeneration, Wet AMD, wAMD, Retinal gene therapy, Intravitreal gene therapy, Genetic Medicine, Ocular Gene Therapy, nAMD, Neoplasm Metastasis, Macular Degeneration, Retinal Neovascularization, Pathologic Neovascularization, Aflibercept, 4D-150 IVT (3E10 vg/eye), EYLEA® (aflibercept) Injection 2 mg (0.05mL), Aflibercept (AFLB) 2 mg IVT

Eligibility

You can join if…

Open to people ages 50 years and up

  • ≥50 years of age at time of consent
  • Treatment naïve MNV secondary to nAMD in the study eye
  • Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT), in the study eye, at the Screening Visit confirmed by the Reading Center
  • Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
  • BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit

You CAN'T join if...

Ocular Conditions:

  • MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage 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 for control

Systemic Conditions and Considerations:

  • Major illness or major surgical procedure in the 28 days prior to the Screening Visit
  • Uncontrolled blood pressure
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
  • History of autoimmune condition that may predispose to the development of uveitis

Locations

  • Jules Stein Eye Institute not yet accepting patients
    Los Angeles California 90095 United States
  • Retina Vitreous Associates Medical Group not yet accepting patients
    Beverly Hills California 90211 United States
  • The Retina Partners not yet accepting patients
    Encino California 91436 United States
  • Sierra Eye Associates accepting new patients
    Reno Nevada 89502 United States
  • Austin Clinical Research accepting new patients
    Austin Texas 78750 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
4D Molecular Therapeutics
ID
NCT06864988
Phase
Phase 3 Macular Degeneration Research Study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated