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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
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 🔄
Completed
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
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

Study Record Dates


Current Stage Phase2
Submit Date 2023-03-07
Completion Date 🔄 2026-02-23
Last Update 🔄 2026-03-13

Participation Criteria


Eligible Age >=60 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: * Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm\^2) to 17.5 mm\^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT) * If GA is multifocal, at least one focal lesion must be greater than or equal to (\>=) 1.25 mm\^2 (0.5- disc area), as assessed by the CRC * GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC * Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better * Man or woman (according to their reproductive organs and functions assigned by chromosomal complement) Exclusion Criteria: * History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye * Any prior thermal laser in the macular region, regardless of indication * History of retinal detachment (with or without repair) * Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis * Any sign of diabetic retinopathy or central serous chorioretinopathy
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

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