An observational study in Retinitis Pigmentosa, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Astellas Pharma Inc · Observational
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
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.
Retinitis pigmentosa, healthy volunteers
Inclusion Criteria for patients with retinitis pigmentosa:
Inclusion Criteria for healthy Volunteers:
Exclusion Criteria:
Retinitis pigmentosa patients with severe visual impairment
Retinitis pigmentosa patients with severe visual impairment
Retinitis pigmentosa patients with severe visual impairment
Healthy volunteers
Slit-lamp microscopy in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
Slit-lamp microscopy in Part 1B and 3
To assess the visual function
Time frame: Day 1
Optical Coherence Tomography (OCT) test in Part 1A and 2
To assess the visual function
Time frame: Day 1
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
Visual acuity test with ETDRS in Part 1B
To assess the visual function
Time frame: 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)
Time frame: 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
Time frame: Up to week 8
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
To assess the psychological adjustment
Time frame: Up to week 8
Daily living task dependent on vision (DLTV) in Part 1A and 2
To assess QOL
Time frame: Up to week 8
Table test in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
Metropsis test in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
Low vision evaluator (LoVE) in Part 1A
To assess the visual function
Time frame: Up to week 8
White flash visual evoked potential (VEP) test in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
White flash VEP test in Part 1B and 3
To assess the visual function
Time frame: Day 1
Color flash VEP test in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
Color flash VEP test in Part 1B and 3
To assess the visual function
Time frame: Day 1
Electrically evoked response (EER) test in Part 1A and 2
To assess the visual function
Time frame: Up to week 8
EER test in Part 1B and 3
To assess the visual function
Time frame: Day 1
White flash electroretinography test in Part 1A, 1B, 2 and 3
To assess the visual function
Time frame: Day 1
Pupillary function test in Part 2
To assess the visual function
Time frame: Up to week 8
Pupillary function test in Part 1B and 3
To assess the visual function
Time frame: Day 1
Full field stimulus threshold testing (FST) in Part 2
To assess the visual function
Time frame: Up to week 8
FST in Part 1B
To assess the visual function
Time frame: Day 1
Plan to share: 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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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc