Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)

NCTID	NCT01301443 (View at clinicaltrials.gov)
Description	The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration. (Show More)
Development Status	Inactive
Indication	Neovascular (Wet) Age-Related Macular Degeneration
Disease Ontology Term	DOID:10871
Compound Name	RetinoStat
Compound Alias	OXB-201
Compound Description	CMV-hEndo-IRES-hAngio-WPRE
Sponsor	Oxford BioMedica
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	21 (ACTUAL)
Results Posted	Not Available

Target Gene/Variant	COL18A1+PLG
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Genetic delivery of therapeutic protein
Route of Administration	Subretinal
Drug Product Type	Viral vector
Target Tissue/Cell
Delivery System	Viral transduction
Vector Type	EIAV
Editor Type	none
Dose 1	2.4E4 TU (n=3)
Dose 2	2.4E5 TU (n=5)
Dose 3	8.0E5 TU (n=15)
Dose 4
Dose 5

No.of Trial Sites	3
Locations	United States

Has US IND	True
FDA Designations
Recent Updates	Oxford Biomedica announced they were discontinuing work on internal product development in 2H2023