4D-150 gene therapy injected into the eye for adults with diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial is randomized, double-masked, and active-controlled, comparing a single intravitreal injection of 4D-150 to aflibercept in adults with DME. It aims to assess safety, efficacy, and how long the effect lasts. Participants will receive injections in one study eye and will be followed over time to monitor vision and retinal outcomes. The study is conducted at selected sites in Arizona and California under a sponsor-led program.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Network Arizona
  Scottsdale, Arizona, United States Recruiting
• The Retina Partners
  Encino, California, United States Recruiting
• Retina Specialists of Colorado - Aurora
  Aurora, Colorado, United States Recruiting
• Southwest Retina Consultants
  Durango, Colorado, United States Recruiting
• Coastal Eye- Greenwich
  Greenwich, Connecticut, United States Recruiting
• Retinal Specialty Institute
  Pensacola, Florida, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: 4DMT Patient Advocacy
• Email: clinicaltrials@4DMT.com
• Phone: (888) 748-8881

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.