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

Recruiting now · Phase 3

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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

Key facts

Study ID

NCT07064759

Run by

4D Molecular Therapeutics

People needed

480

Starts

2025-07-22

Expected to finish

2029-02-01

Last updated by the study team

2026-04-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥50 years of age at time of consent
• MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
• Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
• Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
• 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
• CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center

You may not qualify 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
• 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 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Sun City, Arizona, United States (enrolling)
• Retina Associates — Tucson, Arizona, United States (enrolling)
• Retinal Diagnostic Center — Campbell, California, United States (enrolling)
• Retina Consultants of Orange County — Fullerton, California, United States (enrolling)
• Northern California Retina Vitreous Associates — Mountain View, California, United States (enrolling)
• Retinal Consultants Medical Group Inc. — Sacramento, California, United States (enrolling)
• Retinal Consultants Medical Group — Sacramento, California, United States (enrolling)
• West Coast Retina Medical Group — San Francisco, California, United States (enrolling)
• Bay Area Retina Associates — Walnut Creek, California, United States (enrolling)
• Retina Consultants of Southern Colorado P.C. — Colorado Springs, Colorado, United States (enrolling)
• Southwest Retina Consultants — Durango, Colorado, United States (enrolling)
• ClearVista Clinical Research — Hudson, Florida, United States (enrolling)
• Florida Retina Institute — Orlando, Florida, United States (enrolling)
• Retina Specialty Institute — Pensacola, Florida, United States (enrolling)
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (enrolling)
• East Florida Eye Institute — Stuart, Florida, United States (enrolling)
• Retina Vitreous Associates of Florida — Tampa, Florida, United States (enrolling)
• Thomas Eye Group — Sandy Springs, Georgia, United States (enrolling)
• Retina Associates, Ltd. — Elmhurst, Illinois, United States (enrolling)
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States (enrolling)
• Illinois Retina Associates — Oak Park, Illinois, United States (enrolling)
• Springfield Clinic — Springfield, Illinois, United States (enrolling)
• Retina Partners Midwest, PC — Carmel, Indiana, United States (enrolling)
• The Retina Care Center — Baltimore, Maryland, United States (enrolling)
• Research Network Arizona — Scottsdale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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