UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022686 |
|---|---|
| Receipt number | 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 11:50:19 |
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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
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
ymocl@pathol1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026147
