Contact SCGE




Gene Therapy Trial Report

Summary

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


NCTID NCT01301443 (View at clinicaltrials.gov)
Description
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

Therapy Information


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
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)

Study Record Dates


Current Stage Phase1
Submit Date 2011-02-21
Completion Date 2015-05
Last Update 2017-04-05

Participation Criteria


Eligible Age >=50 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of AMD with active CNV that shows evidence of leakage. * BCVA less than or equal to 20/200 in the study eye for dose escalation phase. * BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase. Exclusion Criteria: * Significant ocular abnormalities that prevent retinal assessment. * Treatment with steroids within three months of screening. * Treatment with anti-VEGF therapy to either eye within one month of screening. * Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay abnormalities.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 3
Locations United States

Regulatory Information


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

Resources/Links