A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME). (4SIGHT)

November 4, 2026 updated by: 4D Molecular Therapeutics

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

514

Phase

  • 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 Backup

Study Locations

  • China
      • Beijing, China, 100730
        • Not yet recruiting
        • Beijing Tongren Hospital
      • Changchun, China, 130041
        • Not yet recruiting
        • The Second Hospital of Jilin University
      • Changsha, China, 410300
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
      • Haerbin, China, 150001
        • Not yet recruiting
        • The Second Affiliated Hospital of Harbin Medical University
      • Hangzhou, China, 310015
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
      • Jinan, China, 250021
        • Not yet recruiting
        • Eye Hospital of Shandong First Medical University
      • Jinan, China, 450006
        • Not yet recruiting
        • Zhengzhou Second Peoples Hospital
      • Lanzhou, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
      • Nanchang, China, 330006
        • Not yet recruiting
        • Nanchang University Affiliated Eye Hospital
      • Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai First People's Hospital
      • Shanghai, China, 200031
        • Not yet recruiting
        • Fudan University - Eye & ENT Hospital
      • Taiyuan, China, 030032
        • Not yet recruiting
        • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital
      • Taizhou, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
      • Tianjin, China, 300384
        • Not yet recruiting
        • Tianjin Medical University Eye Hospital
      • Weifang, China, 261021
        • Not yet recruiting
        • Weifang Eye Hospital
      • Wuhan, China, 430014
        • Not yet recruiting
        • Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan
      • Wuhan, China, 430060
        • Not yet recruiting
        • Wuhan University Renmin Hospital (Hubei General Hospital)
      • Zhengzhou, China, 450003
        • Not yet recruiting
        • Henan Eye Hospital, Henan Provincial People's Hospital
  • Japan
      • Amagasaki-shi, Japan, 660-8550
        • Not yet recruiting
        • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Kyushu University Hospital
      • Fukuoka, Japan, 812-0011
        • Not yet recruiting
        • Hayashi Eye Hospital
      • Fukushima, Japan, 960-1295
        • Not yet recruiting
        • Fukushima Medical University Hospital
      • Hachioji-shi, Japan, 193-0998
        • Not yet recruiting
        • Tokyo Medical University Hachioji Medical Center
      • Kagoshima, Japan, 890-8520
        • Not yet recruiting
        • Kagoshima University Hospital
      • Kita-Gun, Japan, 761-0793
        • Not yet recruiting
        • Kagawa University Hospital
      • Kobe, Japan, 650-0047
        • Not yet recruiting
        • Kobe City Eye Hospital
      • Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Kyoto University Hospital
      • Mitaka-shi, Japan, 181-8611
        • Not yet recruiting
        • Kyorin University - Kyorin University Hospital - Mitaka
      • Miyazaki, Japan, 889-1692
        • Not yet recruiting
        • University of Miyazaki Hospital
      • Nagoya, Japan, 466-8560
        • Not yet recruiting
        • Nagoya University Hospital
      • Sakura-shi, Japan, 285-8741
        • Not yet recruiting
        • Toho University Sakura Medical Center
      • Tokyo, Japan, 152-8902
        • Not yet recruiting
        • National Hospital Organization Tokyo Medical Center
      • Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Juntendo University Hospital
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0845
        • Not yet recruiting
        • Kozawa Eye Hospital and Diabetes Center
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Not yet recruiting
        • Emanuelli Research & Development Center, LLC (ERD)
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Recruiting
        • Research Network Arizona
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • The Retina Partners
      • Fullerton, California, United States, 92835
        • Not yet recruiting
        • Retina Consultants of Orange County
      • Huntington Beach, California, United States, 90266
        • Not yet recruiting
        • Retina Associates of Southern California
      • Sacramento, California, United States, 95825
        • Not yet recruiting
        • Retinal Consultants Medical Group Inc.
      • San Diego, California, United States, 92064
        • Not yet recruiting
        • Retina Consultants San Diego
      • San Mateo, California, United States, 94401
        • Not yet recruiting
        • Retina Institute of New England
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • Bay Area Retina Associates - Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Retina Specialists of Colorado - Aurora
      • Colorado Springs, Colorado, United States, 80909
        • Not yet recruiting
        • Retina Consultants of Southern Colorado P.C.
      • Durango, Colorado, United States, 81303
        • Recruiting
        • Southwest Retina Consultants
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Coastal Eye- Greenwich
      • Waterford, Connecticut, United States, 06385
        • Not yet recruiting
        • Retina Institute of New England, PC
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Not yet recruiting
        • Retina Group of Florida
      • Orlando, Florida, United States, 32806
        • Not yet recruiting
        • Florida Retina Institute
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Retinal Specialty Institute
      • Plantation, Florida, United States, 33324
        • Not yet recruiting
        • Fort Lauderdale Eye Institute (FLEI)-Plantation
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Retina Vitreous Associates of Florida
    • Illinois
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Retina Associates, Ltd.
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina and Macula Associates, PC - Lemont
      • Oak Park, Illinois, United States, 60304
        • Not yet recruiting
        • Illinois Retina Associates
      • Springfield, Illinois, United States, 62703
        • Not yet recruiting
        • Springfield Clinic
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Not yet recruiting
        • Midwest Eye Institute
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Not yet recruiting
        • The Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Not yet recruiting
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Not yet recruiting
        • Mid Atlantic Retina Specialist
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Not yet recruiting
        • Mississippi Retina Associates
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Deep Blue Retina Clinical Research, PLLC
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Not yet recruiting
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Envision Ocular, LLC
      • Edison, New Jersey, United States, 08820
        • Not yet recruiting
        • NJ Retina
    • New York
      • New York, New York, United States, 10017
        • Not yet recruiting
        • NYU Langone Health
      • New York, New York, United States, 13088
        • Recruiting
        • Retina Vitreous Surgeons of CNY, PC
      • Westbury, New York, United States, 11590
        • Not yet recruiting
        • Vitreoretinal Consultants of New York (VRCNY)
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Eye Associates - Retina Division
      • Cary, North Carolina, United States, 27511
        • Not yet recruiting
        • North Carolina Retina Associates - Cary Office
      • Wake Forest, North Carolina, United States, 27587
        • Not yet recruiting
        • North Carolina Retina Associates- Wake Forest
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Not yet recruiting
        • Retina Associates of Cleveland
    • Oklahoma
      • Edmund, Oklahoma, United States, 73013
        • Recruiting
        • Retina Vitreous Center
    • Oregon
      • Portland, Oregon, United States, 97233
        • Not yet recruiting
        • EyeHealth Northwest
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Withdrawn
        • Mid Atlantic Retina
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Mid Atlantic Retina - Philadelphia
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Black Hills Regional Eye Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Tennessee Retina
    • Texas
      • Abilene, Texas, United States, 79606
        • Not yet recruiting
        • West Texas Retina Consultants
      • Austin, Texas, United States, 78750
        • Recruiting
        • Austin Clinical Research
      • Austin, Texas, United States, 78705
        • Not yet recruiting
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Not yet recruiting
        • Austin Research Center for Retina
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associate
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Retina Center
      • Katy, Texas, United States, 77494
        • Not yet recruiting
        • Retina Consultants of Texas - Katy
      • The Woodlands, Texas, United States, 77384
        • Not yet recruiting
        • Retina Consultants of Texas
      • Tyler, Texas, United States, 75703
        • Recruiting
        • Tyler Retina Consultants
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • The Retina Group of Washington
      • Lynchburg, Virginia, United States, 24502
        • Recruiting
        • Piedmont Eye Center
    • Wisconsin
      • Wausau, Wisconsin, United States, 55403
        • Not yet recruiting
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

5.2 Inclusion Criteria

Individuals eligible to participate in the trial must meet the following inclusion criteria:

General Inclusion Criteria

  1. Signed informed consent before any protocol-specified assessment is performed
  2. Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
  3. ≥18 years of age at time of signing informed consent
  4. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  5. WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
  6. Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria
  7. Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
  8. Study eye amenable to IVT injection identified
  9. Presence of intraretinal fluid and/or subretinal fluid secondary to DME
  10. Decreased visual acuity attributable primarily to DME, as determined by the Investigator
  11. Demonstrated clinical response to aflibercept and functional stability in the study eye

Exclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:

Ocular Condition

  1. Macular conditions other than DME

  2. History or presence of moderate Proliferative Diabetic Retinopathy or worse

  3. History of retinal detachment in the study eye

  4. History or presence of active inflammation or infection in either eye

  5. History or presence of low Intraocular Pressure

  6. Uncontrolled glaucoma or intraocular hypertension

    Ocular Treatments/Interventions:

  7. Any prior concomitant treatment for DME

  8. History of prior significant ocular surgery or treatment

  9. Any prior investigational drug, agent, device, or gene therapy

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
Intervention / Treatment
Experimental: 4D-150 IVT (3x10^10 vg/eye)
Biological: 4D-150 IVT (3x10^10 vg)

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: Active Comparator (AFLB) 2mg IVT
Biological: EYELEA ® (aflibercept) Injection 2 mg (0.05mL)

EYLEA ® (aflibercept) will be administered at applicable visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
Time Frame: 52 weeks

The minimum and maximum values are: 0 to 100 The higher the value the better the result
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean annualized number of aflibercept injections after Week 4 through Week 52
Time Frame: Week 4 through Week 52

Minimum 0 maximum 12 One injection per visit, one visit every four weeks
Week 4 through Week 52
Proportion of participants with a ≥ 2-step improvement from baseline in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at Week 52
Time Frame: 52 weeks

ETDRS-DRSS is a visual acuity test Results are analyzing using a generalized estimating equations model
52 weeks

Collaborators and Investigators

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

Sponsor

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 Major Dates

Study Start (Actual)

September 18, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

October 5, 2026

First Submitted That Met QC Criteria

October 5, 2026

First Posted (Actual)

October 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4D-150-C005
  • 4SIGHT (Other Identifier: Sponsor)
  • 4D-150-C005 (Other Identifier: Sponsor)

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 DME 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

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.

Subscribe