Contact SCGE




Clinical Trial Report

Gene Therapy Trial Report

Summary

A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients

NCTID NCT06237777 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Diabetic Macular Edema
Disease Ontology Term DOID:9191
Compound Name SKG0106
Sponsor Wang Min
Funder Type Other
Recruitment Status
Recruiting
Enrollment Count 18
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
Dose 1 Undisclosed dose escalation, 3 levels
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1
Submit Date 2024-01-11
Completion Date 2026-01
Last Update 2024-04-30

Participation Criteria

Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 2
Locations China

Regulatory Information

Has US IND False
FDA Designations
Recent Updates IND for nAMD (2nd indication) was approved in June 2023

Resources/Links

Resources/Links

No External Links Available.