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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05811351
Registration number
NCT05811351
Ethics application status
Date submitted
7/03/2023
Date registered
13/04/2023
Titles & IDs
Public title
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)
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Scientific title
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
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Secondary ID [1]
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81201887MDG2001
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Secondary ID [2]
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CR109236
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-81201887
Treatment: Drugs - Prednisone
Other interventions - Placebo
Treatment: Drugs - Triamcinolone
Other interventions - Sham Procedure
Experimental: Arm A: JNJ-81201887 Low Dose - Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Experimental: Arm B: JNJ-81201887 High dose - Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
Sham comparator: Arm C: Sham Procedure - Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
Treatment: Drugs: JNJ-81201887
JNJ-81201887 will be administered as intravitreal injection.
Treatment: Drugs: Prednisone
Prednisone will be administered as oral capsule.
Other interventions: Placebo
Prednisone matching placebo will be administered as oral capsule.
Treatment: Drugs: Triamcinolone
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
Other interventions: Sham Procedure
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
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Assessment method [1]
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Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
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Timepoint [1]
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Baseline and Month 18
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Secondary outcome [1]
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Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
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Assessment method [1]
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Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
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Timepoint [1]
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Baseline and Month 18
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Secondary outcome [2]
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Change From Baseline in Reading Speed at Month 18
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Assessment method [2]
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Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported.
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Timepoint [2]
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Baseline and Month 18
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Secondary outcome [3]
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Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18
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Assessment method [3]
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Change from baseline retinal sensitivity by MAIA will be reported.
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Timepoint [3]
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Baseline and Month 18
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Secondary outcome [4]
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Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18
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Assessment method [4]
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Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart at a starting distance of 4 meter.
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Timepoint [4]
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Baseline and Month 18
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Secondary outcome [5]
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Change From Baseline in Functional Reading Independence (FRI) Index at Month 18
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Assessment method [5]
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The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.
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Timepoint [5]
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Baseline and Month 18
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Secondary outcome [6]
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Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18
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Assessment method [6]
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The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
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Timepoint [6]
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Baseline and Month 18
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Eligibility
Key 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)
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Minimum age
60
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2023
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Date of last participant enrolment
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Date of last data collection
Anticipated
17/02/2026
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Adelaide Eye and Retina Centre - Adelaide
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Recruitment hospital [2]
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Centre for Eye Research Australia - East Melbourne
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Strathfield Retina Clinic - Strathfield
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Sydney Retina Clinic and Day Surgery - Sydney
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Sydney West Retina - Westmead
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5000 - Adelaide
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3002 - East Melbourne
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2135 - Strathfield
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2000 - Sydney
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2145 - Westmead
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT05811351
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for public queries
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Study Contact
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Address
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Phone
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844-434-4210
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05811351