Development of Visual Function Evaluation Method

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Meguro-ku, Tokyo, Japan
      • Site JP00001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retinitis pigmentosa, healthy volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Retinitis pigmentosa; Visual function evaluation
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: CRE170041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No