AzTrials
AzTrials

Macular Neovascularization Secondary to Age-Related Macular DegenerationPhase 3NCT06864988

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

A Phase 3 study testing 4D-150 IVT (3E10 vg/eye) and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in people with Macular Neovascularization Secondary to Age-Related Macular Degeneration, run by 4D Molecular Therapeutics at 94 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 years and older
What is being tested?
4D-150 IVT (3E10 vg/eye) and EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
94 sitesin 2 countries
Study dates
3 Mar 2025to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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:
Show all 10Show fewer
  • 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

Trial locations and contacts

94 sites in 2 countries.

94 sites in 2 countries

United States90 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Eye Associates of New Mexico Vision Research Center

    Albuquerque, New Mexico, 87109

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research

    Austin, Texas, 78750

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina & Vitreous of Texas, PLLC

    Bellaire, Texas, 77401

  • Retina Consultants of Houston

    Bellaire, Texas, 77401

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Midwest Eye Institute

    Carmel, Indiana, 46290

  • Charleston Neuroscience Center

    Charleston, South Carolina, 29414

  • Retina Group of Washington, Chevy Chase

    Chevy Chase, Maryland, 20815

  • University of Chicago

    Chicago, Illinois, 60637

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44122

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130

  • Cole Eye Institute

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Connecticut Eye Consultants

    Danbury, Connecticut, 06810

  • RSC Research, LLC

    Denver, Colorado, 80210

  • Duke Eye Center

    Durham, North Carolina, 27705

  • NJ Retina

    Edison, New Jersey, 08820

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Retina Associates - Elmhurst

    Elmhurst, Illinois, 60126

  • The Retina Partners

    Encino, California, 91436

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • Retina Group of Washington, Fairfax

    Fairfax, Virginia, 22031

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Vitreo Retinal Associates

    Gainesville, Florida, 34481

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740

  • Texas Retina Center

    Houston, Texas, 77043

  • Retina Associates of Southern California

    Huntington Beach, California, 92647

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida, 32216

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37763

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Vitreous Retina Macula Consultants of New York

    New York, New York, 10022

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • The Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona, 85016

  • Maine Eye Center

    Portland, Maine, 04101

  • EyeHealth Northwest Peterkort

    Portland, Oregon, 97225

  • Retina Consultants of San Diego

    Poway, California, 92064

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Kaiser Permanente-Riverside Medical Center

    Riverside, California, 92505

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95840

  • Retina Associates of South Texas PA

    San Antonio, Texas, 78240

  • Retina Consultants of Texas San Antonio

    San Antonio, Texas, 78240

  • RCTX - Westover Hills Retina Center

    San Antonio, Texas, 78251

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants - Santa Barbara

    Santa Barbara, California, 93103

  • Retina Associates of Sarasota

    Sarasota, Florida, 34232

  • Retinal Research Institute, LLC

    Scottsdale, Arizona, 85254

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi, 38671

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas, 72764

  • Springfield Clinic

    Springfield, Illinois, 62703

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • NJ Retina

    Teaneck, New Jersey, 07666

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • North Carolina (NC) Retina Associates

    Wake Forest, North Carolina, 27587

  • MD Medical Research

    Waldorf, Maryland, 20745

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Piedmont Retina Specialists - Winston Salem Office

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada4 sites

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • Retina Surgical Associates

    New Westminster, British Columbia, V3L 5H1

  • St. Michaels Hospital

    North York, Ontario, M5B 1W8

  • Retina Institute of Ottawa, Inc.

    Ottawa, Ontario, K2B 7E9

Other trials in Canada

About this study

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

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

Being tested
4D-150 IVT (3E10 vg/eye), EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Keywords
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, Retinal gene therapy, Intravitreal gene therapy, Genetic Medicine, Ocular Gene Therapy, nAMD
Medical subject headings
Macular Degeneration, Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4D-150 IVT (3E10 vg/eye)Biological

    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)Biological

    Eylea (aflibercept) will be administered at applicable visits

Study groups in NCT06864988
Study groupRoleWhat they receive
4D-150 IVT (3E10 vg/eye)ExperimentalNot described
Receives: Biological: 4D-150 IVT (3E10 vg/eye)
Aflibercept (AFLB) 2 mg IVTActive comparatorNot described
Receives: Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in BCVA ETDRS letter score at Week 52

    Measured: 52 Weeks

Secondary outcomes (5)

  1. Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104

    Measured: 104 Weeks

  2. Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104

    Measured: 104 Weeks

  3. Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm

    Measured: 104 Weeks

  4. Mean change from baseline in CST over time through Weeks 52 and 104

    Measured: 104 Weeks

  5. Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104

    Measured: 104 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start3 Mar 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864988
Sponsor's protocol ID
4D-150-C003
Status last verified
Oct 2026
First submitted
4 Mar 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4D-150 IVT (3E10 vg/eye) and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in people with Macular Neovascularization Secondary to Age-Related Macular Degeneration, run by 4D Molecular Therapeutics at 94 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in BCVA ETDRS letter score at Week 52 (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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