RECRUITING

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

Conditions

Macular Neovascularization Secondary to Age-Related Macular Degeneration Age-related macular degeneration AMD Exudative AMD Neovascular AMD Exudative age-related macular degeneration Neovascular age-related macular degeneration Wet age-related macular degeneration Wet macular degeneration Wet AMD WAMD nAMD Retinal gene therapy Intravitreal gene therapy Genetic Medicine Ocular Gene Therapy Gene Therapy 4FRONT 4FRONT-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Quick Facts

Study Start:2025-07

Study Completion:2029-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07064759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye * 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

Inclusion Criteria

Exclusion 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

* 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
* Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye
* 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

Contacts and Locations

Study Contact

4DMT Patient Advocacy

CONTACT

(888) 748-8881

clinicaltrials@4DMT.com

Principal Investigator

Julie Tsai, MD

STUDY_DIRECTOR

4D Molecular Therapeutics

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, 85351

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740

United States

Tennessee Retina, PC

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: 4D Molecular Therapeutics

Julie Tsai, MD, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2029-02

Study Record Updates

Study Start Date2025-07

Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

Age-related macular degeneration
AMD
Exudative AMD
Neovascular AMD
Exudative age-related macular degeneration
Neovascular age-related macular degeneration
Wet age-related macular degeneration
Wet macular degeneration
Wet AMD
WAMD
nAMD
Retinal gene therapy
Intravitreal gene therapy
Genetic Medicine
Ocular Gene Therapy
Gene Therapy
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4FRONT-2

Additional Relevant MeSH Terms

Macular Neovascularization Secondary to Age-Related Macular Degeneration