Development of Visual Function Evaluation Method

• ClinicalTrials.gov Identifier: NCT03281005
• Recruitment Status: Completed
• First Posted: September 13, 2017
• Last Update Posted: March 9, 2020
• Sponsor: Astellas Pharma Inc
• Information provided by (Responsible Party): Astellas Pharma Inc

Study Description

Brief Summary:

The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient

Condition or disease
Retinitis Pigmentosa

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

• Study Type: Observational
• Actual Enrollment: 18 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: November 21, 2019
• Actual Study Completion Date: November 21, 2019

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

1. Slit-lamp microscopy in Part 1A and 2 [ Time Frame: Up to week 8 ]
   To assess the visual function
2. Slit-lamp microscopy in Part 1B and 3 [ Time Frame: Day 1 ]
   To assess the visual function
3. Optical Coherence Tomography (OCT) test in Part 1A and 2 [ Time Frame: Day 1 ]
   To assess the visual function
4. 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
5. Visual acuity test with ETDRS in Part 1B [ Time Frame: Day 1 ]
   To assess the visual function
6. 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)
7. 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
8. Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2 [ Time Frame: Up to week 8 ]
   To assess the psychological adjustment
9. Daily living task dependent on vision (DLTV) in Part 1A and 2 [ Time Frame: Up to week 8 ]
   To assess QOL
10. Table test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
11. Metropsis test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
12. Low vision evaluator (LoVE) in Part 1A [ Time Frame: Up to week 8 ]
    To assess the visual function
13. White flash visual evoked potential (VEP) test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
14. White flash VEP test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
15. Color flash VEP test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
16. Color flash VEP test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
17. Electrically evoked response (EER) test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
18. EER test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
19. White flash electroretinography test in Part 1A, 1B, 2 and 3 [ Time Frame: Day 1 ]
    To assess the visual function
20. Pupillary function test in Part 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
21. Pupillary function test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
22. Full field stimulus threshold testing (FST) in Part 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
23. FST in Part 1B [ Time Frame: Day 1 ]
    To assess the visual function

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Retinitis pigmentosa, healthy volunteers

Criteria

Inclusion Criteria for patients with retinitis pigmentosa:

• Age: ≥ 20 years
• Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent

Inclusion Criteria for healthy Volunteers:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Japan

Site JP00001

Meguro-ku, Tokyo, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

• Study Director: Medical Director; Astellas Pharma Inc

More Information

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT03281005
• Other Study ID Numbers: CRE170041
• First Posted: September 13, 2017
• Last Update Posted: March 9, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:

Retinitis pigmentosa; Visual function evaluation

Additional relevant MeSH terms:

Retinitis; Retinitis Pigmentosa; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Degeneration; Genetic Diseases, Inborn