NCT07867080 A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
| NCT ID | NCT07867080 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | 4D Molecular Therapeutics |
| Condition | Diabetic Macular Edema (DME) |
| Study Type | INTERVENTIONAL |
| Enrollment | 514 participants |
| Start Date | 2026-09-18 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 514 participants in total. It began in 2026-09-18 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07867080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema (DME). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07867080 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 514 participants.
Is NCT07867080 currently recruiting?
Yes, NCT07867080 is actively recruiting participants. Contact the research team at clinicaltrials@4DMT.com for enrollment information.
Where is the NCT07867080 trial being conducted?
This trial is being conducted at Scottsdale, United States, Encino, United States, Fullerton, United States, Huntington Beach, United States and 11 additional locations.
Who is sponsoring the NCT07867080 clinical trial?
NCT07867080 is sponsored by 4D Molecular Therapeutics. The trial plans to enroll 514 participants.