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Development of Visual Function Evaluation Method

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ClinicalTrials.gov Identifier: NCT03281005
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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 Type : Observational
Estimated 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281005


Contacts
Contact: Clinical Development Administration Dept. astellas.registration@astellas.com

Locations
Japan
Site JP00001 Recruiting
Meguro, Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03281005     History of Changes
Other Study ID Numbers: CRE170041
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn