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

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 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

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

Value
https://center6.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