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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
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