Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06635148




Registration number
NCT06635148
Ethics application status
Date submitted
23/09/2024
Date registered
10/10/2024
Date last updated
12/09/2025

Titles & IDs
Public title
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Scientific title
Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies
Secondary ID [1] 0 0
81201887MDG3002
Secondary ID [2] 0 0
81201887MDG3002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-81201887
Other interventions - Sham Procedure

Experimental: Arm A: JNJ-81201887 Low Dose - Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.

Experimental: Arm B: JNJ-81201887 High dose - Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.

Sham comparator: Arm C: Sham Procedure - Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) may have the option to receive JNJ-81201887 open-label treatment under a separate protocol after unmasking of that study; and will enter this LTE study. No intervention will be administered as part of this study.


Treatment: Drugs: JNJ-81201887
No study intervention will be administered as part of this LTE study.

Other interventions: Sham Procedure
No study intervention will be administered as part of this LTE study.
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
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Upto 5 Years
Primary outcome [2] 0 0
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments
Timepoint [2] 0 0
Upto 5 Years
Primary outcome [3] 0 0
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
Timepoint [3] 0 0
Upto 5 Years

Eligibility
Key inclusion criteria
* Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
* Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
* Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* There are no exclusion criteria for this LTE study

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2030
Actual
Sample size
Target
311
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Belgium
State/province [23] 0 0
Genk
Country [24] 0 0
Belgium
State/province [24] 0 0
Ghent
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
Czechia
State/province [28] 0 0
Prague
Country [29] 0 0
Denmark
State/province [29] 0 0
Glostrup Municipality
Country [30] 0 0
Germany
State/province [30] 0 0
Göttingen
Country [31] 0 0
Germany
State/province [31] 0 0
Hanover
Country [32] 0 0
Germany
State/province [32] 0 0
Leipzig
Country [33] 0 0
Germany
State/province [33] 0 0
Ludwigshafen am Rhein
Country [34] 0 0
Germany
State/province [34] 0 0
Münster
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Pécs
Country [37] 0 0
Hungary
State/province [37] 0 0
Zalaegerszeg
Country [38] 0 0
Italy
State/province [38] 0 0
Milan
Country [39] 0 0
Italy
State/province [39] 0 0
Napoli
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Netherlands
State/province [41] 0 0
Nijmegen
Country [42] 0 0
Netherlands
State/province [42] 0 0
Rotterdam
Country [43] 0 0
Poland
State/province [43] 0 0
Bydgoszcz
Country [44] 0 0
Portugal
State/province [44] 0 0
Coimbra
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Burjassot
Country [48] 0 0
Spain
State/province [48] 0 0
Córdoba
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Majadahonda
Country [51] 0 0
Spain
State/province [51] 0 0
Pamplona
Country [52] 0 0
Spain
State/province [52] 0 0
Sant Cugat del Vallès
Country [53] 0 0
Spain
State/province [53] 0 0
Seville
Country [54] 0 0
Spain
State/province [54] 0 0
Zaragoza
Country [55] 0 0
Sweden
State/province [55] 0 0
Stockholm
Country [56] 0 0
Switzerland
State/province [56] 0 0
Bern
Country [57] 0 0
Turkey (Türkiye)
State/province [57] 0 0
Ankara
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Headington

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
[email protected]
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/NCT06635148