Phase 3Recruiting
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME). (4SIGHT)
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)
- Sponsor
- 4D Molecular Therapeutics (Industry)
- Enrolment
- 514 planned
- Conditions
- Diabetic Macular Edema (DME)
- Interventions
- 4D-150 IVT (3x10^10 vg); EYELEA ® (aflibercept) Injection 2 mg (0.05mL)
- Ages
- adults, older adults
- Registry
- NCT07867080
Full record on ClinicalTrials.gov
From the registry
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)
Primary outcomes
- Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started