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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
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