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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022686
Receipt No. R000026147
Scientific Title The Clinical Efficacy of Carbonic Anhydrase Inhibitors and Steroids in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
Date of disclosure of the study information 2016/07/01
Last modified on 2019/06/15

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Basic information
Public title The Clinical Efficacy of Carbonic Anhydrase Inhibitors and Steroids in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
Acronym The Clinical Efficacy in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
Scientific Title The Clinical Efficacy of Carbonic Anhydrase Inhibitors and Steroids in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
Scientific Title:Acronym The Clinical Efficacy in the Management of Cystoid Macular Edema in Patients with Retinitis Pigmentosa
Region
Japan

Condition
Condition retinitis pigmentosa
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of carbonic anhydrase inhibitors and steroids in cystoid macular edema associated with retinitis pigmentosa
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes retinal thickness
Key secondary outcomes best-corrected visual acuity, visual field, side effect

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1% dorzolamide eye drop three times daily in each eye
0.1% betamethasone sodium phosphate eye drop three times daily in each eye
oral 250mg acetazolamide two tablets daily
40mg triamcinolone acetonide into the sub-Tenon capsule
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) patients with retinitis pigmentosa
(2) BCVA >= 0.1
(3) patinets whose agreement was shown by him/herself
Key exclusion criteria (1) a past history of glaucoma or intraocular hypertension
(2) patients with another macular disorder, such as epiretinal membrane
(3) a past history of using the test drug within 6 months
(4) pregnant subjects, subjects suspected of being pregnant, or breast-feeding subjects
(5) patients with steroid induced intraocular hypertension
(6) hypersensitivity to these test drugs
(7) a past history of the entry into another clinical trial within 1 year
(8) inappropriate case judged by investigator or subinvestigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Ikeda
Organization Kyushu University Hospital
Division name Department of Ophthalmology
Zip code 8128582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Email ymocl@pathol1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Ikeda
Organization Kyushu University Hospital
Division name Department of Ophthalmology
Zip code 8128582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Homepage URL
Email ymocl@pathol1.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyushu University Certified Institutional Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 22
Results
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 Completed
Date of protocol fixation
2016 Year 06 Month 15 Day
Date of IRB
2016 Year 06 Month 15 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 09 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026147

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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