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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)
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)
Secondary ID [1] 0 0
81201887MDG2001
Secondary ID [2] 0 0
CR109236
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
Timepoint [1] 0 0
Baseline and Month 18
Secondary outcome [1] 0 0
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
Timepoint [1] 0 0
Baseline and Month 18
Secondary outcome [2] 0 0
Change From Baseline in Reading Speed at Month 18
Timepoint [2] 0 0
Baseline and Month 18
Secondary outcome [3] 0 0
Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18
Timepoint [3] 0 0
Baseline and Month 18
Secondary outcome [4] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18
Timepoint [4] 0 0
Baseline and Month 18
Secondary outcome [5] 0 0
Change From Baseline in Functional Reading Independence (FRI) Index at Month 18
Timepoint [5] 0 0
Baseline and Month 18
Secondary outcome [6] 0 0
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18
Timepoint [6] 0 0
Baseline and Month 18

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)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [2] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [3] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [4] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [5] 0 0
Sydney West Retina - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
2135 - Strathfield
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
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Oxford
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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