4D-150 in Patients With Diabetic Macular Edema

NCTID	NCT05930561 (View at clinicaltrials.gov)
Description	Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME). (Show More)
Development Status	Active
Indication	Diabetic Macular Edema, Diabetic Retinopathy
Disease Ontology Term	DOID:9191
Compound Name	4D-150
Sponsor	4D Molecular Therapeutics
Funder Type	Industry
Recruitment Status	Active not recruiting
Enrollment Count	72 (ESTIMATED)
Results Posted	Not Available

Target Gene/Variant	Anti-VEGF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Genetic delivery of therapeutic protein
Route of Administration	Intravitreal
Drug Product Type	Viral vector
Target Tissue/Cell
Delivery System	Viral transduction
Vector Type	AAV R100
Editor Type	none
Dose 1	Dose range: 5E9 -3E10 vg/eye
Dose 2	Planned Phase 3 dose: 3E10 vg/eye
Dose 3
Dose 4
Dose 5

No.of Trial Sites	6
Locations	Puerto Rico,United States

Has US IND	True
FDA Designations	Regenerative Medicine Advanced Therapy
Recent Updates	52-week interim data update expected at a scientific conference in mid-2025