Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
4FRONT-2
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
1 other identifier
interventional
480
14 countries
94
Brief Summary
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Typical duration for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedStudy Start
First participant enrolled
July 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 16, 2026
April 1, 2026
3.3 years
July 7, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in Best Corrected Visual Accuity (BCVA) Early Treatment for Diabetic Retinopathy (ETDRS) letter score at Week 52
52 Weeks
Secondary Outcomes (5)
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
104 Weeks
Mean change from baseline in Central Subfield Thickness (CST) over time through Weeks 52 and 104
104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
104 Weeks
Study Arms (2)
4D-150 IVT (3E10 vg/eye)
EXPERIMENTALAflibercept (AFLB) 2 mg IVT
ACTIVE COMPARATORInterventions
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) will be administered at applicable visits
Eligibility Criteria
You may qualify if:
- ≥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:
- Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Research Network Arizona
Scottsdale, Arizona, 85255, United States
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, 85351, United States
Retina Associates
Tucson, Arizona, 85704, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retinal Consultants Medical Group Inc.
Sacramento, California, 95825, United States
Retinal Consultants Medical Group
Sacramento, California, 95841, United States
West Coast Retina Medical Group
San Francisco, California, 94109, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado, 80909, United States
Southwest Retina Consultants
Durango, Colorado, 81303, United States
ClearVista Clinical Research
Hudson, Florida, 34667, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617, United States
Thomas Eye Group
Sandy Springs, Georgia, 30328, United States
Retina Associates, Ltd.
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Retina Partners Midwest, PC
Carmel, Indiana, 46032, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, 21740, United States
New England Retina Consultants
Springfield, Massachusetts, 01107, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, 13088, United States
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032, United States
Vitreoretinal Consultants of NY
Westbury, New York, 11590, United States
North Carolina Retina Associates
Cary, North Carolina, 27511, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Verum Research, LLC
Eugene, Oregon, 947401, United States
EyeHealth Northwest
Portland, Oregon, 97233, United States
Erie Retina Research
Erie, Pennsylvania, 16505, United States
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina, 29910, United States
Carolina Eyecare
Mt. Pleasant, South Carolina, 29464, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Southwest Retina Specialist - Panhandle Eye group, LLP
Amarillo, Texas, 79106, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Texas Retina Associate
Dallas, Texas, 75231, United States
Tyler Retina Consultants
Tyler, Texas, 75703, United States
Strategic Clinical Research
Willow Park, Texas, 76087, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
Pacific Northwest Retina
Silverdale, Washington, 98383, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403, United States
Grupo Láser Visión
Rosario, Santa Fe Province, 2000, Argentina
Microcirugia Ocular Rosario
Rosario, Santa Fe Province, 2000, Argentina
Centro Privado de Ojos
Buenos Aires, 1033, Argentina
Charles Research Center
Buenos Aires, 1116, Argentina
OFTALMOS
Buenos Aires, 1830, Argentina
Centrovisión
Mendoza, 5500, Argentina
Adelaide Eye and Retina Centre
Adelaide, SA 5000, Australia
Eye Clinic Albury Wodonga
Albury, NSW 2640, Australia
Strathfield Retina Clinic
Strathfield, NSW 2135, Australia
Sydney Retina Clinic and Day Surgery
Sydney, NSW 2000, Australia
Zora Eye Hospital
Sofia, Bulgaria
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, Germany
Augenzentrum Frankfurt
Frankfurt, 60549, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, 17036, Germany
Bajcsy-Zsilinszky Kórház
Budapest, 1106, Hungary
Budapest Retina Associates
Budapest, Hungary
Semmelweis Egyetem - Szemészeti Klinika
Budapest, Hungary
DE KK Ophthalmology Clinic
Debrecen, Hungary
Ganglion Medical Center
Pécs, Hungary
SzTE SZAKK Szemeszeti Klinika
Szeged, Hungary
AOU delle Marche
Ancona, 60126, Italy
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845, Japan
University of the Ryukyus Hospital
Ginowan, Okinawa, 901-2725, Japan
Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital
Fukuoka, 811-0213, Japan
Hayashi Eye Hospital
Fukuoka, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, 152-8902, Japan
P.Stradins University Hospital
Riga, Latvia
Riga East University hospital
Riga, Latvia
Ziemekurzemes Regionala Slimnica
Ventspils, Latvia
Hospital of Lithuanian University of Health Sciences
Kaunas, LT-50161, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Aibili - Cec
Coimbra, Portugal
Singapore Eye Research Institute (SERI)
Singapore, Singapore
Tan Tock Seng Hospital TTSH
Singapore, Singapore
Miranza Instituto Gomez-Ulla
Santiago de Compostela, Spain, 15706, Spain
Clinica Bonanova de Cirugía Ocular
Barcelona, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Bradford Royal Infirmary
Bradford, UK, BD9 6TB, United Kingdom
The Retina Clinic London
London, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julie Tsai, MD
4D Molecular Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2025
First Posted
July 15, 2025
Study Start
July 22, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Data obtained through this study may be provided, after deidentification, to qualified researchers with academic interest in AMD in compliance with ICMJE policy. Data or samples shared will be coded, with no Protected Health Information included. Additionally, descriptions of the study protocol, Statistical Analysis Plan (SAP), informed consent and clinical study report may be shared publicly. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting after final Clinical Study Report and the data will be made accessible for a duration determined by the Sponsor, and in accordance with ICMJE policy. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and execution of a Data Sharing Agreement (DSA).