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Active, not recruiting Phase 3

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

NCT06864988 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-03-03
Last updated
2026-10-26

Condition(s) studied

Macular Neovascularization Secondary to Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

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

4D-150 IVT (3E10 vg/eye): If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1

EYLEA® (aflibercept) Injection 2 mg (0.05mL): Eylea (aflibercept) will be administered at applicable visits

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean change from baseline in BCVA ETDRS letter score at Week 52 — 52 Weeks

Trial sites (94)

FacilityCityRegionStatus
Barnet Dulaney Perkins Eye Center Phoenix Arizona
Retinal Research Institute, LLC Scottsdale Arizona
Retina Partners of Northwest Arkansas Springdale Arkansas
California Retina Consultants Bakersfield California
Retina Vitreous Associates Medical Group Beverly Hills California
The Retina Partners Encino California
Retina Associates of Southern California Huntington Beach California
Northern California Retina Vitreous Associates Mountain View California
Retina Consultants of San Diego Poway California
Kaiser Permanente-Riverside Medical Center Riverside California
Retinal Consultants Medical Group Inc Sacramento California
Retinal Consultants Medical Group Inc Sacramento California
Orange County Retina Medical Group Santa Ana California
California Retina Consultants - Santa Barbara Santa Barbara California
Bay Area Retina Associates Walnut Creek California
University of Colorado, Denver Aurora Colorado
Retina Consultants of Southern Colorado Colorado Springs Colorado
RSC Research, LLC Denver Colorado
Connecticut Eye Consultants Danbury Connecticut
Retina Group of Florida Fort Lauderdale Florida
Vitreo Retinal Associates Gainesville Florida
Florida Retina Institute - Jacksonville Jacksonville Florida
Florida Retina Consultants Lakeland Florida
Florida Retina Institute Orlando Florida
Retina Specialty Institute Pensacola Florida
Retina Associates of Sarasota Sarasota Florida
Retina Vitreous Associates of Florida St. Petersburg Florida
East Florida Eye Institute Stuart Florida
Southeast Retina Center Augusta Georgia
Georgia Retina PC Marietta Georgia
Retina Consultants of Hawaii ‘Aiea Hawaii
University of Chicago Chicago Illinois
Retina Associates - Elmhurst Elmhurst Illinois
University Retina and Macula Associates, PC Lemont Illinois
Illinois Retina Associates Oak Park Illinois
Springfield Clinic Springfield Illinois
Midwest Eye Institute Carmel Indiana
Retina Associates of Kentucky Lexington Kentucky
Maine Eye Center Portland Maine
Retina Group of Washington, Chevy Chase Chevy Chase Maryland

+ 54 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864988 on ClinicalTrials.gov ↗ ← All trials in the USA