Development of Visual Function Evaluation Method

NCT03281005 | Completed

• 1 other identifier: CRE170041
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa; Visual function evaluation

Outcome Measures

Primary Outcomes (23)

• Slit-lamp microscopy in Part 1A and 2

  To assess the visual function

  Up to week 8

• Slit-lamp microscopy in Part 1B and 3

  To assess the visual function

  Day 1

• Optical Coherence Tomography (OCT) test in Part 1A and 2

  To assess the visual function

  Day 1

• Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2

  To assess the visual function

  Up to week 8

• Visual acuity test with ETDRS in Part 1B

  To assess the visual function

  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)

  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

  Up to week 8

• Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2

  To assess the psychological adjustment

  Up to week 8

• Daily living task dependent on vision (DLTV) in Part 1A and 2

  To assess QOL

  Up to week 8

• Table test in Part 1A and 2

  To assess the visual function

  Up to week 8

• Metropsis test in Part 1A and 2

  To assess the visual function

  Up to week 8

• Low vision evaluator (LoVE) in Part 1A

  To assess the visual function

  Up to week 8

• White flash visual evoked potential (VEP) test in Part 1A and 2

  To assess the visual function

  Up to week 8

• White flash VEP test in Part 1B and 3

  To assess the visual function

  Day 1

• Color flash VEP test in Part 1A and 2

  To assess the visual function

  Up to week 8

• Color flash VEP test in Part 1B and 3

  To assess the visual function

  Day 1

• Electrically evoked response (EER) test in Part 1A and 2

  To assess the visual function

  Up to week 8

• EER test in Part 1B and 3

  To assess the visual function

  Day 1

• White flash electroretinography test in Part 1A, 1B, 2 and 3

  To assess the visual function

  Day 1

• Pupillary function test in Part 2

  To assess the visual function

  Up to week 8

• Pupillary function test in Part 1B and 3

  To assess the visual function

  Day 1

• Full field stimulus threshold testing (FST) in Part 2

  To assess the visual function

  Up to week 8

• FST in Part 1B

  To assess the visual function

  Day 1

Study Arms (4)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retinitis pigmentosa, healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Meguro-ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 37895218 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: November 1, 2017
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: October 21, 2024

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)