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Clinical Trial Report

Gene Therapy Trial Report

Summary

Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration


NCTID NCT01494805 (View at clinicaltrials.gov)
Description
Development Status Inactive
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name RAAV.sFlt-1
Compound Description rAAV.CMV.sFlt-1
Sponsor Lions Eye Institute, Perth, Western Australia
Funder Type Other
Recruitment Status
Completed
Enrollment Count 40
Results Posted Not Available

Therapy Information


Target Gene/Variant Soluble VEGFR1
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 AAV
Editor Type
Dose 1 1E10 vg (n=3)
Dose 2 1E11 vg (n=3)
Dose 3 1E11 vg (n=21)
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2011-12-14
Completion Date 2017-08
Last Update 2017-09-01

Participation Criteria


Eligible Age >=55 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 1
Locations Australia

Regulatory Information


Has US IND
FDA Designations
Recent Updates Product was well tolerated, unable to determine efficacy

Resources/Links