NCT07867080 · 4D Molecular Therapeutics
Phase 3 Study of Intravitreal 4D-150 in Adults With Diabetic Macular Edema (DME) (4D-150-C005)
(4SIGHT)
What this study is about
A Phase 3, randomly assigned, Double-Masked, Active-Controlled Trial to Evaluate the Safety, effectiveness, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)
View original scientific description
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)
Interventions
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
BIOLOGICAL
EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
EYLEA ® (aflibercept) will be administered at applicable visits
Primary outcome measures
Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
Time frame: 52 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals eligible to participate in the trial must meet the following inclusion criteria: General Inclusion Criteria
- Signed informed consent before any protocol-specified assessment is performed
- Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
- ≥18 years of age at time of signing informed consent
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation
- 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
- Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye
- Study eye amenable to IVT injection identified
- Presence of intraretinal fluid and/or subretinal fluid secondary to DME
- Decreased visual acuity attributable primarily to DME, as determined by the Investigator
- 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
- Macular conditions other than DME
- History or presence of moderate Proliferative Diabetic Retinopathy or worse
- History of retinal detachment in the study eye
- History or presence of active inflammation or infection in either eye
- History or presence of low Intraocular Pressure
- Uncontrolled glaucoma or intraocular hypertension Ocular Treatments/Interventions:
- Any prior concomitant treatment for DME
- History of prior significant ocular surgery or treatment
- Any prior investigational drug, agent, device, or gene therapy
Where
- Scottsdale, Arizona
- Encino, California
- Fullerton, California
- Sacramento, California
- San Diego, California
- San Mateo, California
- Walnut Creek, California
- Aurora, Colorado
- Colorado Springs, Colorado
- Durango, Colorado
- Greenwich, Connecticut
- Waterford, Connecticut
And 35 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations