Inherited Retinal DiseasesEYERD RegistryNCT05957276
Global Patient Registry of Inherited Retinal Diseases
An observational study of Inherited Retinal Diseases, run by Janssen Research & Development, LLC at 75 sites in 18 countries.
Trial summary
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Inherited Retinal Diseases
- How many people
- 886 participants
- Where
- 75 sitesin 18 countries
- Study dates
- 31 Aug 2023to 2 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Child, Adult, Older adult
Study population: Study population includes adult and pediatric participants with a documented genetic diagnosis of XLRP or ACHM and any signs or symptoms of disease.
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
75 sites in 18 countries.
75 sites in 18 countries
United States18 sites
Univ of Michigan Medical Center
Ann Arbor, Michigan, 48105
Emory University
Atlanta, Georgia, 30322
John Hopkins Hospital
Baltimore, Maryland, 212051832
Retina Consultants of Texas
Bellaire, Texas, 77401
University of Alabama Birmingham
Birmingham, Alabama, 35294
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Houston
Houston, Texas, 77204
University of Iowa
Iowa City, Iowa, 52242
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Southern California
Los Angeles, California, 90033
Bascom Palmer Eye Institute
Miami, Florida, 33136
University Of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Ochsner Medical Center
New Orleans, Louisiana, 70121
UPMC
Pittsburgh, Pennsylvania, 15213
Oregon Health And Science University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
UCSF
San Francisco, California, 94143
China8 sites
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
Beijing Tongren Hospital CMU
Beijing, 100730
Peking Union Medical College Hospital
Beijing, 100730
Sun YatSen University, Zhongshan Ophthalmic Center
Guangzhou, 510060
Eye and ENT Hospital of Fudan University 1
Shanghai, 200031
Shanghai General Hospital
Shanghai, 200080
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Shanghai Aier Eye Hospital
Shanghai, 200336
Italy7 sites
Arcispedale S. Anna Ferrara
Ferrara, 44124
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Ospedale San Raffaele
Milan, 20132
ASST Santi Paolo e Carlo
Milan, 20142
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, 80131
Policlinico Universitario Agostino Gemelli
Roma, 00168
IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS
Roma, 00198
Spain6 sites
Hosp. Univ. de Bellvitge
Barcelona, 08907
Hosp. Sant Joan de Deu
Barcelona, 08950
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Virgen Macarena
Seville, 41009
United Kingdom6 sites
University Hospital Wales
Cardiff, CF244LU
Hull University Teaching Hospitals NHS Trust
Hull, HU32JZ
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Royal Liverpool University Hospital
Liverpool, L7 8XP
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
Sunderland Eye Infirmary
Sunderland, SR29HP
France5 sites
CHU Montpellier
Montpellier, 34295
CHU Nantes
Nantes, F44093
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Hôpital Necker-Enfants Malades
Paris, 75015
Hopitaux universitaires de Strasbourg
Srasbourg, 67091
Brazil4 sites
INRET Clínica e Centro de Pesquisa
Belo Horizonte, 30150-270
On Oftalmologia LTDA
Pinheiros, 05406-900
Clinica Oftalmologica Sao Lucas
São Paulo, 01427-002
Instituto De Genetica Ocular
São Paulo, 04023-061
Japan4 sites
Kyushu University Hospital
Fukuoka, 812-8582
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152 8902
Nagoya University Hospital
Nagoya, 466-8560
Mie University Hospital
Tsu, 514 8507
Australia3 sites
Centre for Eye Research Australia
East Melbourne, 3002
Lions Eye Institute
Nedlands, 6009
Sydney Children's Hospital
Westmead, 2145
South Korea3 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
Austria2 sites
Kepler Universitatsklinikum GmbH
Linz, 4021
Medizinische Universitaet Wien
Vienna, A-1090
Israel2 sites
The Chaim Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Switzerland2 sites
University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical
Basel, 4031
Universite de Lausanne, Hopital ophtalmique Jules-Gonin
Lausanne, 1004
About this study
Official title: NOPRODRPG0002: NOPRODRPG0002 - IRD_RPGR Patient Registry
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.
- Conditions
- Inherited Retinal Diseases
- Being tested
- Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (VA)
VA is a measure of the sharpness of vision. The test uses a chart with letters or symbols of different sizes, at a specific distance, and is reported using various scales, such as fraction, decimal, minimum angle of resolution (MAR), logMAR. When a participant is unable to read a chart, visual acuity can be measured by counting fingers, hand motion, or light perception.
Measured: Baseline up to 8 years
Visual Field (VF)
VF is used to determine scope of vision, including central and peripheral vision. It can determine place, size, and shape of scotoma in vision.
Measured: Baseline up to 8 years
Secondary outcomes (25)
Association Between Inherited Retinal Disease (IRD) Genotype and Visual Acuity
Association between IRD genotype and visual acuity will be reported as incidence of visual acuity for given IRD genotype.
Measured: Baseline up to 8 years
Association Between IRD Genotype and Visual Field
Association between IRD genotype and visual field will be reported as incidence of visual field for given IRD genotype.
Measured: Baseline up to 8 years
Association Between IRD Genotype and Change in Visual Acuity
Association between IRD genotype and change in visual acuity will be reported as change in visual acuity for given IRD genotype.
Measured: Baseline up to 8 years
Association Between IRD Genotype and Change in Visual Field
Association between IRD genotype and change in visual field will be reported as change in visual field for given IRD genotype.
Measured: Baseline up to 8 years
Family History and Inheritance Pattern
Number and relationship with family members diagnosed with IRD will be described.
Measured: Baseline up to 8 years
IRD Variants and Subtypes
Number and distribution of IRD variants and subtypes will be described.
Measured: Baseline up to 8 years
Demographic Characteristics of Participants: Age
Demographic characteristics of participants (age) will be reported.
Measured: Baseline
Demographic Characteristics of Participants: Sex
Demographic characteristics of participants (sex) will be reported.
Measured: Baseline
Demographic Characteristics of Participants: Race
Demographic characteristics of participants (race) will be reported.
Measured: Baseline
Number of Participants With Comorbidities
Number of participants with comorbidities will be reported.
Measured: Baseline
Number of Participants With Various Signs and Symptoms
Number of participants with various signs and symptoms (for example: amblyopia, blindness, corneal disease/dystrophy) will be reported.
Measured: Baseline
Number of Participants With Other Ocular Events
Number of participants with other ocular events will be reported. Other ocular events of interest including cystoid macular edema, macular hole, epiretinal membrane formation, intraocular inflammation, cataracts, glaucoma, chorioretinal atrophy will be described.
Measured: Baseline up to 8 years
Number and Type of Healthcare Professional Visits Prior to Confirmed IRD Diagnosis
Participant diagnostic pathway prior to diagnosis including number and type of healthcare professional visits will be described.
Measured: Baseline up to 8 years
Number and Type of Hospital/Clinic Visit After IRD Diagnosis
Participant management after diagnosis including number and type of hospital/clinic visit will be described.
Measured: Baseline up to 8 years
Medical Resource Utilization
Number and type of hospital/clinic visit, use of assistive device, supportive care, adaptation, and service will be described.
Measured: Baseline up to 8 years
Clinician Global Impression of Severity (CGIS)
CGIS score will be reported for participants with X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM) separately. CGIS is a generic, global, 5-point clinician-administered (observer-rated) scale that assesses illness severity. The score ranging from 1 (no symptoms) through 5 (very severe) to assess disease severity. A higher score indicates more severe disease.
Measured: Baseline up to 8 years
Clinical Global Impression of Change (CGIC)
CGIC score will be reported for XLRP participants. CGIC is a global, generic, 7-point clinician-administered (observer-rated) scale that assesses change in illness severity. The score ranging from 1 (very much improved) through 7 (very much worse). A higher score indicates worsening of disease.
Measured: First post-baseline visit up to 8 years
Participant Global Impression of Severity (PGIS)
The PGIS is a 5-point scale to assess disease severity, for participants with XLRP and ACHM separately. The XLRP PGIS measures participant reported disease severity and impact of XLRP on daily activities, items include: daily activities, mobility, mobility under low luminance/at night, and global rating of severity. A higher score indicates more severe disease. The ACHM PGIS measures participant reported disease severity and impact of ACHM on daily activities, items include: photo aversion (indoors and outdoors), impact on daily activities, and global rating of severity. A higher score indicates more severe disease.
Measured: Baseline up to 8 years
Participant Global Impression of Change (PGIC)
PGIC is a 5-point scale to assess the patient-reported change in disease severity. The XLRP PGIC assesses participant reported perceived change in disease severity and impact of XLRP on daily activities, items include: daily activities, mobility, mobility under low luminance/at night, and global rating of change in severity. A higher score indicates worsening of disease.
Measured: First post-baseline visit up to 8 years
Modified Low Luminance Questionnaire (mLLQ)
The mLLQ is a modified version of the original low luminance questionnaire developed for use in eye diseases to assess self-reported task difficulty under low luminance and at night. The mLLQ uses 5-point or 6-point Likert scales, consists of 6 domains: driving, extreme lighting, mobility, emotional distress, general dim lighting, and peripheral vision. There are 3 age versions: the adult (greater than or equal to [>=] 18 years) version includes 30 items, the adolescent (12-17 years) version includes 22 items, and the caregiver (3-11 years) version includes 19 items. Each domain has a score range of 0-100, with higher scores reflecting a higher level of functioning. Scores will be described per age class separately only for participants with XLRP.
Measured: Baseline up to 8 years
Achromatopsia (ACHM) Vision Impact Questionnaire (AVIQ)
The AVIQ was developed to assess the impact of ACHM on functional vision in children and adults. The AVIQ uses 5-point or 6-point Likert scales. There are 3 age versions: the adult/adolescent (>= 12 years) version includes 15 items, the child (8-11 years) version includes 8 items, and the caregiver (5-7 years) version includes 5 items. Scores will be described per age class separately.
Measured: Baseline up to 8 years
Achromatopsia (ACHM) Symptom and Impact Diary
The ACHM symptom and impact diary assesses the severity of key symptoms of photosensitivity and impaired visual acuity, contrast sensitivity, and color vision. There are 3 age versions: the adult/adolescent (>=12 years) version includes 9 items, the child (8-11 years) version includes 9 items, and the caregiver (5-7 years) version includes 16 items. Scores will be described per age class separately.
Measured: Baseline up to 8 years
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item questionnaire to assess the presence of anxiety and depression in individuals aged 16-65 years, using 4-point Likert scales. Summary scores are reported for the 2 domains. Each domain has a score range of 0-21, with higher scores reflecting increased anxiety or depression.
Measured: Baseline up to 8 years
Work Productivity and Activity Impairment (WPAI)
The WPAI is a 6-item questionnaire that measures the effects of IRD symptoms on work productivity and absenteeism and activity impairment outside of work, using dichotomous (Yes/No) and 0-10 numerical rating scale. The productivity loss would be the total work impairment; the sum of absenteeism and presenteeism. Scores are expressed as impairment percentages, with higher scores reflecting more impairment. This questionnaire will be answered by both study participants and caregiver participants.
Measured: Baseline up to 8 years
Caregiver Burden Score
The caregiver burden score is a 14-item questionnaire developed to assess the impact of IRDs on caregivers of children (ages 3-17 years) with an IRD diagnosis, using 4-point or 6-point Likert scales. It measures caregiver burden in terms of perception of their physical and emotional health, relationships, social life, work, and finances. This questionnaire applies to caregivers of minors only.
Measured: Baseline up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start31 Aug 2023
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957276
- Sponsor's protocol ID
- CR109326
- Other IDs
- NOPRODRPG0002
- Acronym
- EYERD Registry
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOPRODRPG0002: NOPRODRPG0002 - IRD_RPGR Patient Registry
- ClinicalTrials.gov ID
- NCT05957276
- Acronym / sponsor ID
- EYERD Registry / CR109326
- Conditions
- Inherited Retinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Inherited Retinal Diseases (IRDs) | – | Other: Standard of CareAdult 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Study population includes adult and pediatric participants with a documented genetic diagnosis of XLRP or ACHM and any signs or symptoms of disease.
Key inclusion criteria (10 listed)
- 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
- Caregiver has consent from the associated participant to participate in the study, or participant assent and consent from their legally acceptable representative
Key exclusion criteria (4 listed)
- Participant has received a treatment in an IRD-related interventional trial, or is being screened for an IRD-related interventional trial
- Caregiver has an IRD diagnosis and presents with symptoms (visual impairment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareParticipants will not receive any intervention in this study. Participants will receive standard of care therapy. | Other | Participants With Inherited Retinal Diseases (IRDs) |
Primary outcome
Visual Acuity (VA)
Time frame: Baseline up to 8 years
VA is a measure of the sharpness of vision. The test uses a chart with letters or symbols of different sizes, at a specific distance, and is reported using various scales, such as fraction, decimal, minimum angle of resolution (MAR), logMAR. When a participant is unable to read a chart, visual acuity can be measured by counting fingers, hand motion, or light perception.
Visual Field (VF)
Time frame: Baseline up to 8 years
VF is used to determine scope of vision, including central and peripheral vision. It can determine place, size, and shape of scotoma in vision.
25 secondary outcomes
Association Between Inherited Retinal Disease (IRD) Genotype and Visual Acuity
Time frame: Baseline up to 8 years
Association Between IRD Genotype and Visual Field
Time frame: Baseline up to 8 years
Association Between IRD Genotype and Change in Visual Acuity
Time frame: Baseline up to 8 years
Association Between IRD Genotype and Change in Visual Field
Time frame: Baseline up to 8 years
Family History and Inheritance Pattern
Time frame: Baseline up to 8 years
IRD Variants and Subtypes
Time frame: Baseline up to 8 years
Demographic Characteristics of Participants: Age
Time frame: Baseline
Demographic Characteristics of Participants: Sex
Time frame: Baseline
Demographic Characteristics of Participants: Race
Time frame: Baseline
Number of Participants With Comorbidities
Time frame: Baseline
Number of Participants With Various Signs and Symptoms
Time frame: Baseline
Number of Participants With Other Ocular Events
Time frame: Baseline up to 8 years
Number and Type of Healthcare Professional Visits Prior to Confirmed IRD Diagnosis
Time frame: Baseline up to 8 years
Number and Type of Hospital/Clinic Visit After IRD Diagnosis
Time frame: Baseline up to 8 years
Medical Resource Utilization
Time frame: Baseline up to 8 years
Clinician Global Impression of Severity (CGIS)
Time frame: Baseline up to 8 years
Clinical Global Impression of Change (CGIC)
Time frame: First post-baseline visit up to 8 years
Participant Global Impression of Severity (PGIS)
Time frame: Baseline up to 8 years
Participant Global Impression of Change (PGIC)
Time frame: First post-baseline visit up to 8 years
Modified Low Luminance Questionnaire (mLLQ)
Time frame: Baseline up to 8 years
Achromatopsia (ACHM) Vision Impact Questionnaire (AVIQ)
Time frame: Baseline up to 8 years
Achromatopsia (ACHM) Symptom and Impact Diary
Time frame: Baseline up to 8 years
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline up to 8 years
Work Productivity and Activity Impairment (WPAI)
Time frame: Baseline up to 8 years
Caregiver Burden Score
Time frame: Baseline up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
75 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inherited Retinal Diseases, run by Janssen Research & Development, LLC at 75 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, China, Italy, Spain, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (VA) (time frame: Baseline up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.