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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 3

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

514 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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)

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (94)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

94 locations

Study team and timeline

Lead sponsor

4D Molecular Therapeutics

Study start

Sep 18, 2026 Actual

Primary completion

2029-01 Estimated

Study completion

2030-01 Estimated

First posted

Oct 9, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts