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)

4D Molecular Therapeutics

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 duratio…

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

Locations (82)

Research Network Arizona
Scottsdale, Arizona
The Retina Partners
Encino, California
Retina Consultants of Orange County
Fullerton, California
Retinal Consultants Medical Group Inc.
Sacramento, California
Retina Consultants San Diego
San Diego, California
Retina Institute of New England
San Mateo, California