UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007895 |
|---|---|
| Receipt number | R000009301 |
| Scientific Title | Effects of nilvadipine on the progression of visual field defects in patients with retinitis pigmentosa |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2021/07/02 11:37:49 |
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Basic information
Public title
Effects of nilvadipine on the progression of visual field defects in patients with retinitis pigmentosa
Acronym
Effects of nilvadipine on the progression of retinitis pigmentosa
Scientific Title
Effects of nilvadipine on the progression of visual field defects in patients with retinitis pigmentosa
Scientific Title:Acronym
Effects of nilvadipine on the progression of retinitis pigmentosa
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of oral administration of nilvadipine on the progression of central visual field defect in patients with retinitis pigmentosa
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To clarify if the degrees in progression of visual field defect are different between patients with retinitis pigmentosa who take nilvadipine for 30 months and those who do not.
Key secondary outcomes
To clarify if the degrees in progression of visual field defect are different between patients with retinitis pigmentosa who take nilvadipine for longer than 30 months and those who do not.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated group: oral administration of nilvadipine 4mg per day
Interventions/Control_2
Control group: herenien, tocoferol or no medication as patients' requests
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fundus examination showing typical features of retinitis pigmentosa.
Rod-cone degeneration type with rod-predominant degeneration shown on electroretinography and/or subjective symptomes.
Constriction of visual field defects evaluated by either Golfmann perimetry or a Humphrey Visual Field Analyzer.
Residual central visual field better than -35.0dB as evaluated by the 10-2 SITA FAST program
Best corrected visual acuity better than 0.1
Key exclusion criteria
Cataract extraction or other intraocular surgery during observation periods
Systolic blood pressure less than 110 mmHg
Presence of cataract or other media opacities that would disturb fundus examination and/or visual field examination
Use of other calcium antagonists to treat systemic illnesses
Pigmented retinal degeneration secondary to inflammation or presence of ocular diseases other than retinitis pignebtosa
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaihu-cho, Hirosaki, Japan
TEL
0172-39-5094
mitsuru@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaihu-cho
TEL
0172-39-5094
Homepage URL
mitsuru@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine, Committee of Ethics for Medical Researches
Address
5 Zaifu-cho, Hirosaki 036-8562, Japan
Tel
0172-39-5043
rinri@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
弘前大学医学部附属病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.med.hirosaki-u.ac.jp/~ophthal/
Publication of results
Published
Result
URL related to results and publications
http://www.med.hirosaki-u.ac.jp/~ophthal/
Number of participants that the trial has enrolled
50
Results
Mean regression coefficients calculated fronm averaged MD values in the 2 groups during initial 30 months were -035 (dB/y) in the treated group and -0.75 (dB/y) in the control group ( p<0.01, Mann-Whitney).
Results date posted
| 2021 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with retinitis pigmentosa and their systolic blood pressure is greater than 110mmHg
Participant flow
prescribed 20mg of nilvadipine a day and measured 10-2 Humphry's Fiels Analyzer
Adverse events
none
Outcome measures
MD slope
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2001 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2001 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2001 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 01 | Day |
Other
Other related information
published in the following paper
Nakazawa M, Ohguro H, Takeuchi K, Miyagawa Y, Ito T, Metoki T.
Effect of nilvadipine on central visual field in retinitis pigmentosa: a 30-month clinical trial. Ophthalmologica, 225: 120-126, 2011.
Nakazawa M, Suzuki Y, Ito T, Metoki T, Kudo T, Ohguro H.
Long-term effects of nilvadipine against progression of the central visual field defect in retinitis pigmentosa: An extended study. Biomed Res Int 2013; 2013:585729. Doi: 10.1155/585729. Epub 2013 Nov 12.
Management information
Registered date
| 2012 | Year | 05 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009301
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