Development of Visual Function Evaluation Method

Retinitis Pigmentosa Clinical Trial

Official title:

Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281005
• Other study ID #: CRE170041
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: November 21, 2019

Study information

• Verified date: March 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
Japan	Site JP00001	Meguro-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slit-lamp microscopy in Part 1A and 2	To assess the visual function	Up to week 8
Primary	Slit-lamp microscopy in Part 1B and 3	To assess the visual function	Day 1
Primary	Optical Coherence Tomography (OCT) test in Part 1A and 2	To assess the visual function	Day 1
Primary	Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2	To assess the visual function	Up to week 8
Primary	Visual acuity test with ETDRS in Part 1B	To assess the visual function	Day 1
Primary	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
Primary	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
Primary	Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2	To assess the psychological adjustment	Up to week 8
Primary	Daily living task dependent on vision (DLTV) in Part 1A and 2	To assess QOL	Up to week 8
Primary	Table test in Part 1A and 2	To assess the visual function	Up to week 8
Primary	Metropsis test in Part 1A and 2	To assess the visual function	Up to week 8
Primary	Low vision evaluator (LoVE) in Part 1A	To assess the visual function	Up to week 8
Primary	White flash visual evoked potential (VEP) test in Part 1A and 2	To assess the visual function	Up to week 8
Primary	White flash VEP test in Part 1B and 3	To assess the visual function	Day 1
Primary	Color flash VEP test in Part 1A and 2	To assess the visual function	Up to week 8
Primary	Color flash VEP test in Part 1B and 3	To assess the visual function	Day 1
Primary	Electrically evoked response (EER) test in Part 1A and 2	To assess the visual function	Up to week 8
Primary	EER test in Part 1B and 3	To assess the visual function	Day 1
Primary	White flash electroretinography test in Part 1A, 1B, 2 and 3	To assess the visual function	Day 1
Primary	Pupillary function test in Part 2	To assess the visual function	Up to week 8
Primary	Pupillary function test in Part 1B and 3	To assess the visual function	Day 1
Primary	Full field stimulus threshold testing (FST) in Part 2	To assess the visual function	Up to week 8
Primary	FST in Part 1B	To assess the visual function	Day 1