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

Not Applicable

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: NCT07064759
• 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

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-11
• Study Completion: 2029-02-01

Recruitment & Eligibility

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

Inclusion Criteria

• ≥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:

  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 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

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

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

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 (3)

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

Cumberland Valley Retina Consultants; 🇺🇸 Hagerstown, Maryland, United States

Tennessee Retina, PC; 🇺🇸 Nashville, Tennessee, United States