Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing 4D-150 IVT (3x10^10 vg) for Diabetic Macular Edema (DME)

A Phase 3, randomly assigned, Double-Masked, Active-Controlled Trial to measure the Safety, how well it works, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)

Official registry: https://clinicaltrials.gov/study/NCT07867080 · 4D Molecular Therapeutics · enrollment listed as 514

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 4D-150 IVT (3x10^10 vg), or EYELEA ® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. A Phase 3, randomly assigned, Double-Masked, Active-Controlled Trial to measure the Safety, how well it works, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)

They plan to enroll about 514 people at 94 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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)

Interventions: 4D-150 IVT (3x10^10 vg), EYELEA ® (aflibercept) Injection 2 mg (0.05mL)

Primary outcome (registry wording): Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Individuals eligible to participate in the trial must meet the following who can join:
  • General who can join
  • Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment
  • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  • 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 who can join
  • 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

Public study contact (from the registry)

4DMT Patient Advocacy

(888) 748-8881

clinicaltrials@4DMT.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

94 listed

+ 35 sites outside the US on the same record

FAQ about this NCT record

Is NCT07867080 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07867080?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07867080?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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