Contact SCGE




Gene Therapy Trial Report

Summary

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


NCTID NCT06864988 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Compound Name 4D-150
Sponsor 4D Molecular Therapeutics
Funder Type Industry
Recruitment Status 🔄
Active not recruiting
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 1E10 vg/eye
Dose 2 3E10 vg/eye (planned phase 3 dose)

Study Record Dates


Current Stage Phase3
Submit Date 2025-03-04
Completion Date 2028-06
Last Update 🔄 2026-03-25

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 * 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
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 🔄 100
Locations Canada,United States

Regulatory Information


Has US IND True
FDA Designations Regenerative Medicine Advanced Therapy
Recent Updates Phase III trial to begin Q1 2025

Resources/Links