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

May 28, 2026 updated by: 4D Molecular Therapeutics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 5H1
        • Retina Surgical Associates
    • Ontario
      • North York, Ontario, Canada, M5B 1W8
        • St. Michaels Hospital
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Institute of Ottawa, Inc.
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Barnet Dulaney Perkins Eye Center
      • Scottsdale, Arizona, United States, 85254
        • Retinal Research Institute, LLC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Retina Partners of Northwest Arkansas
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Encino, California, United States, 91436
        • The Retina Partners
      • Huntington Beach, California, United States, 92647
        • Retina Associates of Southern California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Poway, California, United States, 92064
        • Retina Consultants of San Diego
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside Medical Center
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group Inc
      • Sacramento, California, United States, 95840
        • Retinal Consultants Medical Group Inc
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants - Santa Barbara
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Denver, Colorado, United States, 80210
        • RSC Research, LLC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Gainesville, Florida, United States, 34481
        • Vitreo Retinal Associates
      • Jacksonville, Florida, United States, 32216
        • Florida Retina Institute - Jacksonville
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Sarasota, Florida, United States, 34232
        • Retina Associates of Sarasota
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Elmhurst, Illinois, United States, 60126
        • Retina Associates - Elmhurst
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates, PC
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Haik Humble Eye Center
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington, Chevy Chase
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants PC
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists - Hagerstown
      • Waldorf, Maryland, United States, 20745
        • MD Medical Research
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Mississippi Retina Associates
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63128
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
      • Edison, New Jersey, United States, 08820
        • NJ Retina
      • Teaneck, New Jersey, United States, 07666
        • NJ Retina
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Eye Associates of New Mexico Vision Research Center
    • New York
      • Liverpool, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central New York
      • New York, New York, United States, 10022
        • Vitreous Retina Macula Consultants of New York
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
      • Durham, North Carolina, United States, 27705
        • Duke Eye Center
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina (NC) Retina Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Piedmont Retina Specialists - Winston Salem Office
    • Ohio
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44122
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44195
        • Cole Eye Institute
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research, LLC
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest Peterkort
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Mid Atlantic Retina
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
      • Philadelphia, Pennsylvania, United States, 19104
        • The Scheie Eye Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Neuroscience Center
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37763
        • Southeastern Retina Associates
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Houston
      • Bellaire, Texas, United States, 77401
        • Retina & Vitreous of Texas, PLLC
      • Houston, Texas, United States, 77043
        • Texas Retina Center
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas PA
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas San Antonio
      • San Antonio, Texas, United States, 78251
        • RCTX - Westover Hills Retina Center
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Retina Group of Washington, Fairfax
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia
    • Wisconsin
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 4D-150 IVT (3E10 vg/eye)
Biological: 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
Active Comparator: Aflibercept (AFLB) 2 mg IVT
Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change from baseline in BCVA ETDRS letter score at Week 52
Time Frame: 52 Weeks
52 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm
Time Frame: 104 Weeks
104 Weeks
Mean change from baseline in CST over time through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks
Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104
Time Frame: 104 Weeks
104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4D Molecular Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hersh Patel, 4D Molecular Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4D-150-C003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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