Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
NCT ID: NCT07064759
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-07-22
2029-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
NCT06864988
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
NCT02581891
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
NCT06398080
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
NCT00964795
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT02540954
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
4D-150 IVT (3E10 vg/eye)
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
Aflibercept (AFLB) 2 mg IVT
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
4D Molecular Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie Tsai, MD
Role: STUDY_DIRECTOR
4D Molecular Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States
Retina Associates
Tucson, Arizona, United States
Retinal Diagnostic Center
Campbell, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
West Coast Retina Medical Group
San Francisco, California, United States
Southwest Retina Consultants
Durango, Colorado, United States
ClearVista Clinical Research
Hudson, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
The Retina Care Center
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States
Vitreoretinal Consultants of NY
Westbury, New York, United States
North Carolina Retina Associates
Cary, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Verum Research, LLC
Eugene, Oregon, United States
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina, United States
Carolina Eyecare
Mt. Pleasant, South Carolina, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas, United States
Texas Retina Associate
Dallas, Texas, United States
Tyler Retina Consultants
Tyler, Texas, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
Pacific Northwest Retina
Silverdale, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4D-150-C004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.