4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Phase 3

Recruiting

• Conditions: Macular Neovascularization Secondary to Age-Related Macular Degeneration
• Interventions: Biological: 4D-150 IVT (3E10 vg/eye); Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

• Registration Number: NCT06864988
• Lead Sponsor: 4D Molecular Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4D-150 IVT (3E10 vg/eye)	4D-150 IVT (3E10 vg/eye)	-
Aflibercept (AFLB) 2 mg IVT	EYLEA® (aflibercept) Injection 2 mg (0.05mL)	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in BCVA ETDRS letter score at Week 52	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104	104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104	104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm	104 Weeks
Mean change from baseline in CST over time through Weeks 52 and 104	104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104	104 Weeks

Trial Locations

Locations (95)

Barnet Dulaney Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Retinal Research Institute, LLC; 🇺🇸 Scottsdale, Arizona, United States

Retina Partners of Northwest Arkansas; 🇺🇸 Springdale, Arkansas, United States

California Retina Consultants; 🇺🇸 Bakersfield, California, United States

Retina Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

The Retina Partners; 🇺🇸 Encino, California, United States

Retina Associates of Southern California; 🇺🇸 Huntington Beach, California, United States

Loma Linda University Faculty Medical Clinics; 🇺🇸 Loma Linda, California, United States

Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

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