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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.
(Show More)
Development Status
Active
Indication
Geographic Atrophy
Disease Ontology Term
DOID:10871
Compound Name
JNJ-1887
Compound Description
AAVCAGsCD59
Sponsor
Janssen Research & Development, LLC
Funder Type
Industry
Recruitment Status
Active not recruiting
Enrollment Count
305 (ACTUAL)
Results Posted
Not Available
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
none
Dose 1
3.56E10 vg/eye
Dose 2
1.071E11 vg/mL
Dose 3
3.56E11 vg/eye
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2023-03-07
Completion Date
2026-02-26
Last Update
2025-11-07
Participation Criteria
Eligible Age
>=60 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
162
Locations
Hungary,United States,Czechia,United Kingdom,Portugal,Switzerland,Spain,Canada,Netherlands,Sweden,Belgium,Turkey (Türkiye),Denmark,Poland,Italy,Australia,Germany
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Resources/Links
Clinical Publications
(Abstract) Pooled safety analysis of a single intravitreal injection of JNJ-1887 (gene therapy, AAVCAGsCD59) in patients with age-related macular degeneration (AMD) - ARVO 2023
Phase 1 Study of JNJ-81201887 Gene Therapy in Geographic Atrophy Secondary to Age-Related Macular Degeneration
(Abstract) Phase 1 Study of JNJ-81201887 Gene Therapy in Geographic Atrophy (GA) Due to Age-related Macular Degeneration (AMD) - EURETINA 2023
News and Press Releases
CLINICAL TRIAL DOWNLOAD: Data on a Gene Therapy for Dry and Wet AMD
Related NCTID
Phase 1: NCT03585556 (with anti-VEGF for Wet AMD)
Phase 1: NCT03144999 (for Dry AMD)