UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000026147