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Clinical Trial Report

Gene Therapy Trial Report

Summary

4D-150 in Patients With Diabetic Macular Edema


NCTID NCT05930561 (View at clinicaltrials.gov)
Description
Indication Diabetic Macular Edema
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
Dose 1 Dose range: 5 x 10^9 -3 x 10^10 vg/eye
Dose 2 Planned Phase III dose: 3x10^10 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 2023-11-13

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 Interim Phase 2 analysis: Q4 2024

Resources/Links