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Diabetic Macular Edema (DME)Phase 34SIGHTNCT07867080

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

A Phase 3 study testing 4D-150 IVT (3x10^10 vg) and EYELEA ® (aflibercept) Injection 2 mg (0.05mL) in people with Diabetic Macular Edema (DME), run by 4D Molecular Therapeutics at 92 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
4D-150 IVT (3x10^10 vg) and EYELEA ® (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
514 participants
Where
92 sitesin 4 countries
Study dates
18 Sep 2026to Jan 2030
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

92 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

4DMT Patient Advocacy contact

(888) 748-8881

clinicaltrials@4DMT.com

4SIGHT Medical Monitoring Distribution List contact

4D150C005_MM@4dmt.com

92 sites in 4 countries

United States57 sites, 56 recruiting

  • West Texas Retina Consultants

    Abilene, Texas, 79606

    Not yet recruiting

  • Asheville Eye Associates - Retina Division

    Asheville, North Carolina, 28803

    Recruiting

  • Retina Specialists of Colorado - Aurora

    Aurora, Colorado, 80012

    Recruiting

  • Austin Research Center for Retina

    Austin, Texas, 78705

    Not yet recruiting

  • Austin Retina Associates

    Austin, Texas, 78705

    Not yet recruiting

  • Austin Clinical Research

    Austin, Texas, 78750

    Recruiting

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

    Withdrawn

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

    Recruiting

  • Midwest Eye Institute

    Carmel, Indiana, 46032

    Not yet recruiting

  • North Carolina Retina Associates - Cary Office

    Cary, North Carolina, 27511

    Not yet recruiting

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

    Not yet recruiting

  • Retina Consultants of Southern Colorado P.C.

    Colorado Springs, Colorado, 80909

    Not yet recruiting

  • Texas Retina Associate

    Dallas, Texas, 75231

    Recruiting

  • Southwest Retina Consultants

    Durango, Colorado, 81303

    Recruiting

  • NJ Retina

    Edison, New Jersey, 08820

    Not yet recruiting

  • Retina Vitreous Center

    Edmund, Oklahoma, 73013

    Recruiting

  • Retina Associates, Ltd.

    Elmhurst, Illinois, 60126

    Recruiting

  • The Retina Partners

    Encino, California, 91436

    Recruiting

  • The Retina Group of Washington

    Fairfax, Virginia, 22031

    Recruiting

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

    Not yet recruiting

  • Retina Consultants of Orange County

    Fullerton, California, 92835

    Not yet recruiting

  • Coastal Eye- Greenwich

    Greenwich, Connecticut, 06830

    Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

    Not yet recruiting

  • Mid Atlantic Retina Specialist

    Hagerstown, Maryland, 21740

    Not yet recruiting

  • Texas Retina Center

    Houston, Texas, 77030

    Recruiting

  • Retina Associates of Southern California

    Huntington Beach, California, 90266

    Not yet recruiting

  • Retina Consultants of Texas - Katy

    Katy, Texas, 77494

    Not yet recruiting

  • University Retina and Macula Associates, PC - Lemont

    Lemont, Illinois, 60439

    Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

    Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

    Not yet recruiting

  • Retina Associates of Cleveland

    Middleburg Heights, Ohio, 44130

    Not yet recruiting

  • Tennessee Retina

    Nashville, Tennessee, 37203

    Not yet recruiting

  • NYU Langone Health

    New York, New York, 10017

    Not yet recruiting

  • Retina Vitreous Surgeons of CNY, PC

    New York, New York, 13088

    Recruiting

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

    Not yet recruiting

  • Florida Retina Institute

    Orlando, Florida, 32806

    Not yet recruiting

  • Retinal Specialty Institute

    Pensacola, Florida, 32503

    Recruiting

  • Mid Atlantic Retina - Philadelphia

    Philadelphia, Pennsylvania, 19107

    Not yet recruiting

  • Fort Lauderdale Eye Institute (FLEI)-Plantation

    Plantation, Florida, 33324

    Not yet recruiting

  • EyeHealth Northwest

    Portland, Oregon, 97233

    Not yet recruiting

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

    Recruiting

  • Sierra Eye Associates

    Reno, Nevada, 89502

    Recruiting

  • Retinal Consultants Medical Group Inc.

    Sacramento, California, 95825

    Not yet recruiting

  • Retina Consultants San Diego

    San Diego, California, 92064

    Not yet recruiting

  • Retina Institute of New England

    San Mateo, California, 94401

    Not yet recruiting

  • Research Network Arizona

    Scottsdale, Arizona, 85255

    Recruiting

  • Deep Blue Retina Clinical Research, PLLC

    Southaven, Mississippi, 38671

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62703

    Not yet recruiting

  • The Retina Institute

    St Louis, Missouri, 63128

    Not yet recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33607

    Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

    Not yet recruiting

  • Tyler Retina Consultants

    Tyler, Texas, 75703

    Recruiting

  • North Carolina Retina Associates- Wake Forest

    Wake Forest, North Carolina, 27587

    Not yet recruiting

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California, 94598

    Not yet recruiting

  • Retina Institute of New England, PC

    Waterford, Connecticut, 06385

    Not yet recruiting

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 55403

    Not yet recruiting

  • Vitreoretinal Consultants of New York (VRCNY)

    Westbury, New York, 11590

    Not yet recruiting

Other trials in United States

China18 sites, 18 recruiting

  • Beijing Tongren Hospital

    Beijing, 100730

    Not yet recruiting

  • The Second Hospital of Jilin University

    Changchun, 130041

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 410300

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Haerbin, 150001

    Not yet recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310015

    Not yet recruiting

  • Eye Hospital of Shandong First Medical University

    Jinan, 250021

    Not yet recruiting

  • Zhengzhou Second Peoples Hospital

    Jinan, 450006

    Not yet recruiting

  • Lanzhou University Second Hospital

    Lanzhou, 730030

    Not yet recruiting

  • Nanchang University Affiliated Eye Hospital

    Nanchang, 330006

    Not yet recruiting

  • Fudan University - Eye & ENT Hospital

    Shanghai, 200031

    Not yet recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080

    Not yet recruiting

  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital

    Taiyuan, 030032

    Not yet recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317000

    Not yet recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin, 300384

    Not yet recruiting

  • Weifang Eye Hospital

    Weifang, 261021

    Not yet recruiting

  • Huazhong University of Science and Technology-Tongji Medical College-The Central Hospital of Wuhan

    Wuhan, 430014

    Not yet recruiting

  • Wuhan University Renmin Hospital (Hubei General Hospital)

    Wuhan, 430060

    Not yet recruiting

  • Henan Eye Hospital, Henan Provincial People's Hospital

    Zhengzhou, 450003

    Not yet recruiting

Other trials in China

Japan16 sites, 16 recruiting

  • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

    Amagasaki-shi, 660-8550

    Not yet recruiting

  • Hayashi Eye Hospital

    Fukuoka, 812-0011

    Not yet recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Not yet recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Not yet recruiting

  • Tokyo Medical University Hachioji Medical Center

    Hachioji-shi, 193-0998

    Not yet recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520

    Not yet recruiting

  • Kagawa University Hospital

    Kita-Gun, 761-0793

    Not yet recruiting

  • Kobe City Eye Hospital

    Kobe, 650-0047

    Not yet recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Not yet recruiting

  • Kyorin University - Kyorin University Hospital - Mitaka

    Mitaka-shi, 181-8611

    Not yet recruiting

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki, 310-0845

    Not yet recruiting

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

    Not yet recruiting

  • Nagoya University Hospital

    Nagoya, 466-8560

    Not yet recruiting

  • Toho University Sakura Medical Center

    Sakura-shi, 285-8741

    Not yet recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431

    Not yet recruiting

  • National Hospital Organization Tokyo Medical Center

    Tokyo, 152-8902

    Not yet recruiting

Other trials in Japan

Puerto Rico1 site, 1 recruiting

  • Emanuelli Research & Development Center, LLC (ERD)

    Arecibo, 00612

    Not yet recruiting

Other trials in Puerto Rico

About this study

Official title: 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)

Being tested
4D-150 IVT (3x10^10 vg), EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
Keywords
Diabetic Macular Edema, DME, Retinal gene therapy, Intravitreal gene therapy, Genetic Medicine, Ocular Gene Therapy, Eye Diseases, Intravitreal Injections, Aflibercept
Medical subject headings
Eye Diseases

What participants receive

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

  • 4D-150 IVT (3x10^10 vg)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

  • EYELEA ® (aflibercept) Injection 2 mg (0.05mL)Biological

    EYLEA ® (aflibercept) will be administered at applicable visits

Study groups in NCT07867080
Study groupRoleWhat they receive
4D-150 IVT (3x10^10 vg/eye)ExperimentalNot described
Receives: Biological: 4D-150 IVT (3x10^10 vg)
Active Comparator (AFLB) 2mg IVTActive comparatorNot described
Receives: Biological: EYELEA ® (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 Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52

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

    Measured: 52 weeks

Secondary outcomes (2)

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

    Minimum 0 maximum 12 One injection per visit, one visit every four weeks

    Measured: Week 4 through Week 52

  2. 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

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

    Measured: 52 weeks

Timeline

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

  1. First posted9 Oct 2026
  2. Study start18 Sep 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2030 (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
514 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07867080
Sponsor's protocol ID
4D-150-C005
Other IDs
4SIGHT, 4D-150-C005
Acronym
4SIGHT
Status last verified
Nov 2026
First submitted
5 Oct 2026
Last updated
5 Nov 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 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)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4D-150 IVT (3x10^10 vg) and EYELEA ® (aflibercept) Injection 2 mg (0.05mL) in people with Diabetic Macular Edema (DME), run by 4D Molecular Therapeutics at 92 sites in 4 countries.

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

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, China, Japan, Puerto Rico. 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?

Contact 4DMT Patient Advocacy ((888) 748-8881, clinicaltrials@4DMT.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity 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 NCT07867080.

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 5 Nov 2026.

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