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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
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)
Indication
Diabetic Macular Edema, Diabetic Retinopathy
Compound Name
4D-150
Sponsor
4D Molecular Therapeutics
Funder Type
Industry
Status
Recruiting
Enrollment Count
72
Therapy Information
Target Gene/Variant
MiVEGFC
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
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
Study Record Dates
Current Stage
Phase2
Submit Date
2023-06-26
Completion Date
2028-07-01
Last Update
2024-12-04
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Eligible Sex
ALL
Locations
No.of Trial Sites
15
Locations
Puerto Rico,United States
Regulatory Information
Has US IND
True
Recent Updates
52-week interim data update expected at a scientific conference in mid-2025
Resources/Links
Clinical Publications
(Corporate Presentation) DME Clinical Trial: Part I, Interim 32-week Results - January 2025
News and Press Releases
4DMT Focuses Pipeline to Prioritize 4D-150 in Wet AMD & DME