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

Development of Visual Function Evaluation Method (2)



Sponsors

Lead Sponsor



Source

Astellas Pharma Inc

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

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

Overall Status

Not yet recruiting

Start Date

2018-08-01

Completion Date

2019-09-01

Primary Completion Date

2019-09-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

Slit-lamp-microscopy
Up to 3 months
Optical Coherence Tomography (OCT) test
Day 1
Early Treatment Diabetic Retinopathy Study (ETDRS)
Up to 3 months
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
Up to 3 months
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)
Up to 3 months
Nottingham Adjustment Scale Japanese Version (NAS-J)
Up to 3 months
Daily living task dependent on vision (DLTV) questionnaire
Up to 3 months
Table test
Up to 3 months
Monitor test
Up to 3 months
Pupillary function test
Up to 3 months
Full field stimulus threshold testing (FST)
Up to 3 months
White flash visual evoked potential (VEP) test
Up to 3 months
Color flash VEP test
Up to 3 months
Electrically evoked response (EER) test
Up to 3 months
White flash Electroretinography (ERG) test
Day 1
Multifocal ERG test
Up to 3 months

Number Of Groups

1

Enrollment

8

Condition


Eligibility

Study Pop

Retinitis pigmentosa

Sampling Method

Non-Probability Sample

Criteria

Inclusion Criteria:

- Subjects with severe visual disturbance (count-fingers or worse vision for severe
eyes) at the time of obtaining the consent and at screening

Exclusion Criteria:

- Subjects should not have participated in any other clinical trial or clinical study
involving visual function evaluation within 6 months

- 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

Gender

All

Minimum Age

20 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Medical Director
Study Director
Astellas Pharma Inc

Overall Contact

Last Name

Clinical Development Administration Dept.

Email



Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Retinitis pigmentosa

Description

Retinitis pigmentosa patients with severe visual impairment


Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No

Ipd Description

Access to anonymized individual patient 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 Information for Astellas."


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Only

Time Perspective

Prospective


Study First Submitted

August 8, 2018

Study First Submitted Qc

August 8, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 8, 2018

Last Update Submitted Qc

August 8, 2018

Last Update Posted

August 10, 2018


ClinicalTrials.gov processed this data on August 27, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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