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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007895
Receipt No. 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 2017/11/10

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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
Middle name
Last name Mitsuru Nakazawa
Organization Hirosaki University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 5 Zaihu-cho, Hirosaki, Japan
TEL 0172-39-5094
Email mitsuru@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Nakazawa
Organization Hirosaki University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 5 Zaihu-cho
TEL 0172-39-5094
Homepage URL
Email mitsuru@hirosaki-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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
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
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2001 Year 04 Month 01 Day
Date of IRB
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
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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