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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
NCTID
NCT05811351
(View at clinicaltrials.gov)
Description
The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
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Indication
Geographic Atrophy
Compound Name
JNJ-1887 (AAVCAGsCD59)
Sponsor
Janssen Research & Development, LLC
Funder Type
Industry
Status
Active not recruiting
Enrollment Count
305
Therapy Information
Target Gene/Variant
CD59
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Intravitreal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV2
Editor Type
Dose 1
3.56 x 10^11 vg/eye
Dose 2
1.071 x 10^12 vg/mL
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2023-03-07
Completion Date
2026-03-08
Last Update
2024-10-24
Participation Criteria
Eligible Age
>=60 Years
Standard Ages
Adult, Older adult
Eligible Sex
ALL
Locations
No.of Trial Sites
162
Locations
Hungary,United States,Czechia,United Kingdom,Portugal,Switzerland,Spain,Canada,Netherlands,Sweden,Turkey,Belgium,Denmark,Poland,Italy,Australia,Germany
Regulatory Information
Has US IND
True
Recent Updates
Resources/Links
Patents
WO2023089564A1
Clinical Publications
PMID: 38909914
https://euretina.softr.app/amsterdam-abstract?recordId=recSojB3Cs4Bx4GBD
https://iovs.arvojournals.org/article.aspx?articleid=2786197
https://retinalphysician.com/issues/2020/april/clinical-trial-download-data-on-a-gene-therapy-for-dry-and-wet-amd/