Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)

4D Molecular Therapeutics (4DMT)

Status and phase: Enrolling; Phase 3

Conditions: Macular Neovascularization Secondary to Age-Related Macular Degeneration

Treatments: Biological: 4D-150 IVT (3E10 vg/eye); Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07064759

4D-150-C004

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups

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

Experimental group

Treatment:

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

Aflibercept (AFLB) 2 mg IVT

Active Comparator group

Treatment:

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