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Gene Therapy Trial Report

Summary

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


NCTID NCT07064759 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name 4D-150
Sponsor 4D Molecular Therapeutics
Funder Type Industry
Recruitment Status
Enrollment Count 480 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant Anti-VEGF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Intravitreal
Drug Product Type Viral vector
Delivery System Viral transduction
Vector Type AAV
Editor Type none
Dose 1 Phase 1/2 doses: 1E10 vg/eye, 3E10 vg/eye
Dose 2 Phase 3 dose: 3E10 vg/eye

Study Record Dates


Current Stage Phase3
Submit Date 2025-07-07
Completion Date 2029-02
Last Update 2026-02-12

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
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
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 43
Locations Argentina,Latvia,Singapore,Hungary,United States,Japan,United Kingdom,Bulgaria,Lithuania,Portugal,Germany,Spain

Regulatory Information


Has US IND True
FDA Designations Regenerative Medicine Advanced Therapy
Recent Updates 4D-150 is also being evaluated for the treatment of Diabetic macular edema in a Phase 2 trial (NCT05930561)

Resources/Links