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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)
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
Recruiting
Enrollment Count
72
Results Posted
Not Available
Therapy Information
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
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
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
15
Locations
Puerto Rico,United States
Regulatory Information
Has US IND
True
FDA Designations
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
SEC Form 10-Q: 4D Molecular Therapeutics, Inc. Q3 2024