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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05957276




Registration number
NCT05957276
Ethics application status
Date submitted
29/06/2023
Date registered
24/07/2023

Titles & IDs
Public title
Global Patient Registry of Inherited Retinal Diseases
Scientific title
Global Patient Registry of Inherited Retinal Disease
Secondary ID [1] 0 0
NOPRODRPG0002
Secondary ID [2] 0 0
CR109326
Universal Trial Number (UTN)
Trial acronym
EYERD Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inherited Retinal Diseases 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Standard of Care

Participants With Inherited Retinal Diseases (IRDs) - Adult and pediatric (greater than or equal to \[\>=\] 3 years) participants with a documented genetic diagnosis of X-linked retinitis pigmentosa (XLRP) or Achromatopsia (ACHM) and any signs or symptoms of IRD or documented retinal changes detected by imaging or electrophysiology.


Other interventions: Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual Acuity (VA)
Timepoint [1] 0 0
Baseline up to 8 years
Primary outcome [2] 0 0
Visual Field (VF)
Timepoint [2] 0 0
Baseline up to 8 years
Secondary outcome [1] 0 0
Association Between Inherited Retinal Disease (IRD) Genotype and Visual Acuity
Timepoint [1] 0 0
Baseline up to 8 years
Secondary outcome [2] 0 0
Association Between IRD Genotype and Visual Field
Timepoint [2] 0 0
Baseline up to 8 years
Secondary outcome [3] 0 0
Association Between IRD Genotype and Change in Visual Acuity
Timepoint [3] 0 0
Baseline up to 8 years
Secondary outcome [4] 0 0
Association Between IRD Genotype and Change in Visual Field
Timepoint [4] 0 0
Baseline up to 8 years
Secondary outcome [5] 0 0
Family History and Inheritance Pattern
Timepoint [5] 0 0
Baseline up to 8 years
Secondary outcome [6] 0 0
IRD Variants and Subtypes
Timepoint [6] 0 0
Baseline up to 8 years
Secondary outcome [7] 0 0
Demographic Characteristics of Participants: Age
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Demographic Characteristics of Participants: Sex
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Demographic Characteristics of Participants: Race
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Number of Participants With Comorbidities
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Number of Participants With Various Signs and Symptoms
Timepoint [11] 0 0
Baseline
Secondary outcome [12] 0 0
Number of Participants With Other Ocular Events
Timepoint [12] 0 0
Baseline up to 8 years
Secondary outcome [13] 0 0
Number and Type of Healthcare Professional Visits Prior to Confirmed IRD Diagnosis
Timepoint [13] 0 0
Baseline up to 8 years
Secondary outcome [14] 0 0
Number and Type of Hospital/Clinic Visit After IRD Diagnosis
Timepoint [14] 0 0
Baseline up to 8 years
Secondary outcome [15] 0 0
Medical Resource Utilization
Timepoint [15] 0 0
Baseline up to 8 years
Secondary outcome [16] 0 0
Clinician Global Impression of Severity (CGIS)
Timepoint [16] 0 0
Baseline up to 8 years
Secondary outcome [17] 0 0
Clinical Global Impression of Change (CGIC)
Timepoint [17] 0 0
First post-baseline visit up to 8 years
Secondary outcome [18] 0 0
Participant Global Impression of Severity (PGIS)
Timepoint [18] 0 0
Baseline up to 8 years
Secondary outcome [19] 0 0
Participant Global Impression of Change (PGIC)
Timepoint [19] 0 0
First post-baseline visit up to 8 years
Secondary outcome [20] 0 0
Modified Low Luminance Questionnaire (mLLQ)
Timepoint [20] 0 0
Baseline up to 8 years
Secondary outcome [21] 0 0
Achromatopsia (ACHM) Vision Impact Questionnaire (AVIQ)
Timepoint [21] 0 0
Baseline up to 8 years
Secondary outcome [22] 0 0
Achromatopsia (ACHM) Symptom and Impact Diary
Timepoint [22] 0 0
Baseline up to 8 years
Secondary outcome [23] 0 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [23] 0 0
Baseline up to 8 years
Secondary outcome [24] 0 0
Work Productivity and Activity Impairment (WPAI)
Timepoint [24] 0 0
Baseline up to 8 years
Secondary outcome [25] 0 0
Caregiver Burden Score
Timepoint [25] 0 0
Baseline up to 8 years

Eligibility
Key inclusion criteria
For Participant Selection:

* Participant has any clinically documented sign(s) and/or symptom(s) consistent with an Inherited Retinal Disease (IRD), or asymptomatic with documented retinal changes detected by imaging or electrophysiology
* Participant has documented genetic variant(s) (known pathogenic, likely pathogenic, or variants of uncertain significance) in relevant genes for any of the following IRDs: X-Linked Retinitis Pigmentosa (XLRP) and/or Achromatopsia (ACHM)
* Participant or legally acceptable representative has provided informed consent (and participant assent, when applicable) in accordance with local requirements
* Participant is able to have relevant visual and/or retinal assessments performed

For Caregiver Selection:

* Caregiver has consent from the associated participant to participate in the study, or participant assent and consent from their legally acceptable representative
* Male or female aged greater than or equal to (>=)18 years
* Identified by an enrolled participant (or their legally acceptable representative*) as a primary caregiver
* Caregiver has provided informed consent in accordance with local requirements
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Participant Selection:

- Participant has received a treatment in an IRD-related interventional trial, or is being screened for an IRD-related interventional trial

For Caregiver Selection:

- Caregiver has an IRD diagnosis and presents with symptoms (visual impairment)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/05/2031
Actual
Sample size
Target
7000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Brazil
State/province [16] 0 0
Belo Horizonte
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
Denmark
State/province [21] 0 0
Glostrup
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Nantes
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
Germany
State/province [26] 0 0
Bonn
Country [27] 0 0
Israel
State/province [27] 0 0
Ramat Gan
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Gyeonggi-do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Donostia-San Sebastián
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Switzerland
State/province [37] 0 0
Basel
Country [38] 0 0
Switzerland
State/province [38] 0 0
Lausanne
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Cardiff
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Hull
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Leeds
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Liverpool
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Southampton
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Sunderland

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)?
No
No/undecided IPD sharing reason/comment


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/NCT05957276