Retinitis PigmentosaNCT03281005
Development of Visual Function Evaluation Method
An observational study of Retinitis Pigmentosa, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2017to 21 Nov 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retinitis pigmentosa, healthy volunteers
Who may be able to join
- Age: ≥ 20 years
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent
- Age: ≥ 35 and ≤ 75 years
- Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening
Who cannot join
- Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
- Pregnant women
- Subjects who are judged that continuation of the study is difficult during the study period
- Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
Read the detailed description
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Visual function evaluation
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retinitis pigmentosa in Part 1A | Retinitis pigmentosa patients with severe visual impairment | |
| Retinitis pigmentosa in Part 1B | Retinitis pigmentosa patients with severe visual impairment | |
| Retinitis pigmentosa in Part 2 | Retinitis pigmentosa patients with severe visual impairment | |
| Healthy volunteers in Part 3 | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit-lamp microscopy in Part 1A and 2
To assess the visual function
Measured: Up to week 8
Slit-lamp microscopy in Part 1B and 3
To assess the visual function
Measured: Day 1
Optical Coherence Tomography (OCT) test in Part 1A and 2
To assess the visual function
Measured: Day 1
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
To assess the visual function
Measured: Up to week 8
Visual acuity test with ETDRS in Part 1B
To assess the visual function
Measured: Day 1
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
To assess the visual function and the quality of life (QOL)
Measured: Up to week 8
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
To assess the visual function and QOL
Measured: Up to week 8
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
To assess the psychological adjustment
Measured: Up to week 8
Daily living task dependent on vision (DLTV) in Part 1A and 2
To assess QOL
Measured: Up to week 8
Table test in Part 1A and 2
To assess the visual function
Measured: Up to week 8
Metropsis test in Part 1A and 2
To assess the visual function
Measured: Up to week 8
Low vision evaluator (LoVE) in Part 1A
To assess the visual function
Measured: Up to week 8
White flash visual evoked potential (VEP) test in Part 1A and 2
To assess the visual function
Measured: Up to week 8
White flash VEP test in Part 1B and 3
To assess the visual function
Measured: Day 1
Color flash VEP test in Part 1A and 2
To assess the visual function
Measured: Up to week 8
Color flash VEP test in Part 1B and 3
To assess the visual function
Measured: Day 1
Electrically evoked response (EER) test in Part 1A and 2
To assess the visual function
Measured: Up to week 8
EER test in Part 1B and 3
To assess the visual function
Measured: Day 1
White flash electroretinography test in Part 1A, 1B, 2 and 3
To assess the visual function
Measured: Day 1
Pupillary function test in Part 2
To assess the visual function
Measured: Up to week 8
Pupillary function test in Part 1B and 3
To assess the visual function
Measured: Day 1
Full field stimulus threshold testing (FST) in Part 2
To assess the visual function
Measured: Up to week 8
FST in Part 1B
To assess the visual function
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Nov 2017
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281005
- Sponsor's protocol ID
- CRE170041
- Status last verified
- Mar 2020
- First submitted
- 11 Sep 2017
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Fujinami-Yokokawa Y, Yang L, Joo K, Tsunoda K, Liu X, Kondo M, Ahn SJ, Li H, Park KH, Tachimori H, Miyata H, Woo SJ, Sui R, Fujinami K. Occult Macular Dysfunction Syndrome: Identification of Multiple Pathologies in a Clinical Spectrum of Macular Dysfunction with Normal Fundus in East Asian Patients: EAOMD Report No. 5. Genes (Basel). 2023 Sep 26;14(10):1869. doi: 10.3390/genes14101869.
PubMed 37895218
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
- ClinicalTrials.gov ID
- NCT03281005
- Acronym / sponsor ID
- CRE170041
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Visual function evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 13 Sep 2017 (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 objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
Detailed description
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retinitis pigmentosa in Part 1A | – | –Retinitis pigmentosa patients with severe visual impairment |
| Retinitis pigmentosa in Part 1B | – | –Retinitis pigmentosa patients with severe visual impairment |
| Retinitis pigmentosa in Part 2 | – | –Retinitis pigmentosa patients with severe visual impairment |
| Healthy volunteers in Part 3 | – | –Healthy volunteers |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retinitis pigmentosa, healthy volunteers
Key inclusion criteria (4 listed)
- Age: ≥ 20 years
- Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent
- Age: ≥ 35 and ≤ 75 years
- Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening
Key exclusion criteria (5 listed)
- Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
- Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
- Pregnant women
- Subjects who are judged that continuation of the study is difficult during the study period
- Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Slit-lamp microscopy in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
Slit-lamp microscopy in Part 1B and 3
Time frame: Day 1
To assess the visual function
Optical Coherence Tomography (OCT) test in Part 1A and 2
Time frame: Day 1
To assess the visual function
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
Visual acuity test with ETDRS in Part 1B
Time frame: Day 1
To assess the visual function
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
Time frame: Up to week 8
To assess the visual function and the quality of life (QOL)
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
Time frame: Up to week 8
To assess the visual function and QOL
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
Time frame: Up to week 8
To assess the psychological adjustment
Daily living task dependent on vision (DLTV) in Part 1A and 2
Time frame: Up to week 8
To assess QOL
Table test in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
Metropsis test in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
Low vision evaluator (LoVE) in Part 1A
Time frame: Up to week 8
To assess the visual function
White flash visual evoked potential (VEP) test in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
White flash VEP test in Part 1B and 3
Time frame: Day 1
To assess the visual function
Color flash VEP test in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
Color flash VEP test in Part 1B and 3
Time frame: Day 1
To assess the visual function
Electrically evoked response (EER) test in Part 1A and 2
Time frame: Up to week 8
To assess the visual function
EER test in Part 1B and 3
Time frame: Day 1
To assess the visual function
White flash electroretinography test in Part 1A, 1B, 2 and 3
Time frame: Day 1
To assess the visual function
Pupillary function test in Part 2
Time frame: Up to week 8
To assess the visual function
Pupillary function test in Part 1B and 3
Time frame: Day 1
To assess the visual function
Full field stimulus threshold testing (FST) in Part 2
Time frame: Up to week 8
To assess the visual function
FST in Part 1B
Time frame: Day 1
To assess the visual function
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 21 Oct 2024.
- Derived from this study: PubMed 37895218Fujinami-Yokokawa Y, Yang L, Joo K, Tsunoda K, Liu X, Kondo M, Ahn SJ, Li H, Park KH, Tachimori H, Miyata H, Woo SJ, Sui R, Fujinami K. Occult Macular Dysfunction Syndrome: Identification of Multiple Pathologies in a Clinical Spectrum of Macular Dysfunction with Normal Fundus in East Asian Patients: EAOMD Report No. 5. Genes (Basel). 2023 Sep 26;14(10):1869. doi: 10.3390/genes14101869.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa, run by Astellas Pharma Inc at 1 site in Japan.
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 4 inclusion and 5 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Slit-lamp microscopy in Part 1A and 2 (time frame: Up to week 8). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281005, which also lists 1 linked publication.
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 21 Oct 2024.