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Clinical Trials in the UK / NCT07064759
Recruiting Phase 3

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

NCT07064759 · tracked via the Priya Life Science UK tracker
Sponsor
4D Molecular Therapeutics
Phase
Phase 3
Started
2025-07-22
Last updated
2026-04-16

Condition(s) studied

Neovascular Age-Related Macular Degeneration (nAMD)

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 * 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

Primary outcome measure(s)

Trial sites (94)

FacilityCityRegionStatus
Research Network Arizona Scottsdale Arizona Recruiting
Barnet Dulaney Perkins Eye Center Sun City Arizona Recruiting
Retina Associates Tucson Arizona Recruiting
Retinal Diagnostic Center Campbell California Recruiting
Retina Consultants of Orange County Fullerton California Recruiting
Northern California Retina Vitreous Associates Mountain View California Recruiting
Retinal Consultants Medical Group Inc. Sacramento California Recruiting
Retinal Consultants Medical Group Sacramento California Recruiting
West Coast Retina Medical Group San Francisco California Recruiting
Bay Area Retina Associates Walnut Creek California Recruiting
Retina Consultants of Southern Colorado P.C. Colorado Springs Colorado Recruiting
Southwest Retina Consultants Durango Colorado Recruiting
ClearVista Clinical Research Hudson Florida Recruiting
Florida Retina Institute Orlando Florida Recruiting
Retina Specialty Institute Pensacola Florida Recruiting
Retina Vitreous Associates of Florida St. Petersburg Florida Recruiting
East Florida Eye Institute Stuart Florida Recruiting
Retina Vitreous Associates of Florida Tampa Florida Recruiting
Thomas Eye Group Sandy Springs Georgia Recruiting
Retina Associates, Ltd. Elmhurst Illinois Recruiting
University Retina and Macula Associates, PC Oak Forest Illinois Recruiting
Illinois Retina Associates Oak Park Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Retina Partners Midwest, PC Carmel Indiana Recruiting
The Retina Care Center Baltimore Maryland Recruiting
Cumberland Valley Retina Consultants Hagerstown Maryland Recruiting
Mid Atlantic Retina Specialist Hagerstown Maryland Recruiting
New England Retina Consultants Springfield Massachusetts Recruiting
Foundation for Vision Research Grand Rapids Michigan Recruiting
Sierra Eye Associates Reno Nevada Recruiting
Envision Ocular, LLC Bloomfield New Jersey Recruiting
Retina Vitreous Surgeons of CNY PC Liverpool New York Recruiting
New York Presbyterian Hospital - Columbia University Medical Center New York New York Recruiting
Vitreoretinal Consultants of NY Westbury New York Recruiting
North Carolina Retina Associates Cary North Carolina Recruiting
North Carolina Retina Associates Wake Forest North Carolina Recruiting
Cincinnati Eye Institute Cincinnati Ohio Recruiting
Verum Research, LLC Eugene Oregon Recruiting
EyeHealth Northwest Portland Oregon Recruiting
Erie Retina Research Erie Pennsylvania Recruiting

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

Other trials for the same condition

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 NCT07064759 on ClinicalTrials.gov ↗ ← All trials in the UK