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Development of Visual Function Evaluation Method

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281005
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date September 11, 2017
First Posted Date September 13, 2017
Last Update Posted Date March 9, 2020
Actual Study Start Date November 1, 2017
Actual Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2018)
  • Slit-lamp microscopy in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Slit-lamp microscopy in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • Optical Coherence Tomography (OCT) test in Part 1A and 2 [ Time Frame: Day 1 ]
    To assess the visual function
  • 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
  • Visual acuity test with ETDRS in Part 1B [ Time Frame: Day 1 ]
    To assess the visual function
  • 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)
  • 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
  • Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the psychological adjustment
  • Daily living task dependent on vision (DLTV) in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess QOL
  • Table test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Metropsis test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Low vision evaluator (LoVE) in Part 1A [ Time Frame: Up to week 8 ]
    To assess the visual function
  • White flash visual evoked potential (VEP) test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • White flash VEP test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • Color flash VEP test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Color flash VEP test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • Electrically evoked response (EER) test in Part 1A and 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • EER test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • White flash electroretinography test in Part 1A, 1B, 2 and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • Pupillary function test in Part 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Pupillary function test in Part 1B and 3 [ Time Frame: Day 1 ]
    To assess the visual function
  • Full field stimulus threshold testing (FST) in Part 2 [ Time Frame: Up to week 8 ]
    To assess the visual function
  • FST in Part 1B [ Time Frame: Day 1 ]
    To assess the visual function
Original Primary Outcome Measures
 (submitted: September 11, 2017)
  • The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Up to week 8 ]
    To assess the visual function and the quality of life (QOL)
  • The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) [ Time Frame: Up to week 8 ]
    To assess the visual function and the quality of life (QOL)
  • Nottingham Adjustment Scale Japanese Version (NAS-J) [ Time Frame: Up to week 8 ]
    To assess the psychological adjustment
  • Daily living task dependent on vision (DLTV) [ Time Frame: Up to week 8 ]
    To assess the quality of life (QOL)
  • Table test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Low vision evaluator (LoVE) [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Metropsis test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Color flash visual evoked potential (VEP) test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Electrically evoked response (EER) test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Up to week 8 ]
    To assess the visual function
  • Optical Coherence Tomography (OCT) test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • White flash VEP test [ Time Frame: Up to week 8 ]
    To assess the visual function
  • White flash Electroretinography test [ Time Frame: Up to week 8 ]
    To assess the visual function
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of Visual Function Evaluation Method
Official Title Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
Brief Summary The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Retinitis pigmentosa, healthy volunteers
Condition Retinitis Pigmentosa
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 6, 2018)		 18
Original Estimated Enrollment
 (submitted: September 11, 2017)		 6
Actual Study Completion Date November 21, 2019
Actual Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03281005
Other Study ID Numbers CRE170041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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."
Current Responsible Party Astellas Pharma Inc
Original Responsible Party Same as current
Current Study Sponsor Astellas Pharma Inc
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date March 2020