UMIN-CTR Clinical Trial

Public title

Effects of orally taken kallidinogenase on retinal blood flow among patients with central retinal vein occlusion (CRVO)

Acronym

Effects of orally taken kallidinogenase on retinal blood flow among patients with central retinal vein occlusion (CRVO)

Scientific Title

Effects of orally taken kallidinogenase on retinal blood flow among patients with central retinal vein occlusion (CRVO)

Scientific Title:Acronym

Effects of orally taken kallidinogenase on retinal blood flow among patients with central retinal vein occlusion (CRVO)

Region

Japan

Condition

Macular edema associated with CRVO

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate systemic effects of oral administration of kallidinogenase on retinal blood flow of patients who were previously administered anti VEGF for treating macular edema associated with CRVO in a comparative research of two groups

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in volume of retinal blood flow from pretreatment to a month after the final treatment or to the last visit

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are included in this study.
1. At 20 years of age or older
2. Male or female
3. Treated with anti VEGF for a year or longer at our hospital (Nagasaki University Hospital)
4. The first anti VEGF treatment at our hospital was between June, 2010 and June, 30, 2014

Key exclusion criteria

Patients who fall into any of the following criteria are excluded from participating in the study.
1. Anti VEGF treatment at our hospital lasts less than a year
2. Ischemic CRVO
3. Others whom an investigator determined to be inappropriate to include in the study

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Kitaoka

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Ophthalmology and Visual Sciences

Zip code

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki

TEL

095-819-7345

Email

tkitaoka@nagasaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Makiko Matsumoto , Fumito Akiyama

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Ophthalmology and Visual Sciences

Zip code

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki

TEL

095-819-7345

Homepage URL

Email

makimaki@nagasaki-u.ac.jp

Institute

Nagasaki University Hospital

Institute

Department

Personal name

Organization

Sanwa Kagaku Kenkyusho Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

長崎大学病院 / Nagasaki University Hospital

Date of disclosure of the study information

2015

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://medicalfinder.jp/doi/abs/10.11477/mf.1410211838

Number of participants that the trial has enrolled

Results

This retrospective study was based on 56 patients previously treated with anti VEGF intravitreal administration several times for macular edema associated with CRVO. Of 26 patients prescribed with oral kallidinogenase by their physicians continued the treatment regimen and the rest of the 30 patients without being administered with kallidinogenase were followed for one year.

Mean visual acuity was significantly improved (P< 0.01) and the mean foveal thickness was significantly reduced (P< 0.01). However, there was no significant difference between the two groups. Blood circulation observed in major retinal vessels in the disc area was significantly improved in the kallidinogenase administered group (167 plus or minus 73%), as well as in the other group without kallidinogenase treatment (125 plus or minus 37%). The improvement was significantly greater in the group with kallidinogenase treatment (P< 0.05) compared to the group treated without kallidinogenase.

We conclude that use of kallidinogenase is effective in treating disease such as CRVO affecting optic nerve blood flow especially in improving chorioretinal blood flow and suppressing VEGF.

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

05

Month

27

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

It is a retrospective study of comparing retinal blood flow of patients who did or did not use kallidinogenase after using anti VEGF for treating macular edema associated with CRVO.

Registered date

2015

Year

09

Month

16

Day

Last modified on

2016

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021987