Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
892 participants
OBSERVATIONAL
2023-08-31
2026-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Interventions
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Standard of Care
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
\- 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)
3 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California
Los Angeles, California, United States
UCSF
San Francisco, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Univ of Michigan Medical Center
Ann Arbor, Michigan, United States
University Of Minnesota Medical Center
Minneapolis, Minnesota, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
UPMC
Pittsburgh, Pennsylvania, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Houston
Houston, Texas, United States
Centre for Eye Research Australia
East Melbourne, , Australia
Lions Eye Institute
Nedlands, , Australia
Sydney Children's Hospital
Westmead, , Australia
Kepler Universitatsklinikum GmbH
Linz, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
Ghent University Hospital
Ghent, , Belgium
INRET Clínica e Centro de Pesquisa
Belo Horizonte, , Brazil
On Oftalmologia LTDA
Pinheiros, , Brazil
Clinica Oftalmologica Sao Lucas
São Paulo, , Brazil
Instituto De Genetica Ocular
São Paulo, , Brazil
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Beijing Tongren Hospital CMU
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Sun YatSen University, Zhongshan Ophthalmic Center
Guangzhou, , China
Eye and ENT Hospital of Fudan University
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai Aier Eye Hospital
Shanghai, , China
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Helsingin Yliopistollinen Keskussairaala
Helsinki, , Finland
CHU Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hopitaux universitaires de Strasbourg
Srasbourg, , France
Universitatsklinikum Bonn
Bonn, , Germany
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Arcispedale S. Anna Ferrara
Ferrara, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST Santi Paolo e Carlo
Milan, , Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Napoli, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS
Roma, , Italy
Kyushu University Hospital
Fukuoka, , Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, , Japan
Nagoya University Hospital
Nagoya, , Japan
Mie University Hospital
Tsu, , Japan
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. Univ. de Bellvitge
Barcelona, , Spain
Hosp. Sant Joan de Deu
Barcelona, , Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Virgen Macarena
Seville, , Spain
University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical
Basel, , Switzerland
Universite de Lausanne, Hopital ophtalmique Jules-Gonin
Lausanne, , Switzerland
University Hospital Wales
Cardiff, , United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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Other Identifiers
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NOPRODRPG0002
Identifier Type: OTHER
Identifier Source: secondary_id
CR109326
Identifier Type: -
Identifier Source: org_study_id