UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019667
Receipt number R000022369
Scientific Title Methotrexate intravitreal injection to intraocular malignant lymphoma patients
Date of disclosure of the study information 2015/11/06
Last modified on 2015/11/24 13:32:51

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Basic information

Public title

Methotrexate intravitreal injection to intraocular malignant lymphoma patients

Acronym

Methotrexate intravitreal injection to intraocular malignant lymphoma patients

Scientific Title

Methotrexate intravitreal injection to intraocular malignant lymphoma patients

Scientific Title:Acronym

Methotrexate intravitreal injection to intraocular malignant lymphoma patients

Region

Japan


Condition

Condition

intraocular malignant lymphoma

Classification by specialty

Ophthalmology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the validity of the intravitrealinjection of methotrexate to a malignant lymphoma patienats.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The degree of improvement of the clinical presentation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

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

Injection of 400 ug of methotrexate into a vitreous cabity twice a week for 1 month as introduction therapy, once a week for 1 month as reinforcement therapy, and once a month for 1 year as maintenance therapy.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) patients that has a malignant lymphoma , have choroid infiltrate and vitreal opacity and isn't effectual for radiotherapy.
2) more than 20 years old, less than 90 years old in the time of the agreement
3) male and female
4) informed consented patients
5) hospitalizing and foreignness

Key exclusion criteria

1) the patient an overlap of other retina vitreous diseases fixes or doubts
2) the patient who can't have a doubtful point in a fixation check and get consent between the medical specialist
3) the patient who participated in a clinical clinical trial within 3 months of sample extraction
4) the patient who allowed a study responsibility doctor to be unsuitable

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Kimura

Organization

Yamaguchi university hospital

Division name

ophthalmology

Zip code


Address

Minami Kogushi1-1-1, Yamaguhi, Ube

TEL

0836-22-2278

Email

k.kimura@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Kimura

Organization

Yamaguchi university hospital

Division name

ophthalmology

Zip code


Address

Minami Kogushi1-1-1, Yamaguhi, Ube

TEL

0836-22-2278

Homepage URL


Email

k.kimura@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi university hospital

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi university hospital ophthalmology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 11 Month 06 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


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

Enrolling by invitation

Date of protocol fixation

2006 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2006 Year 12 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 06 Day

Last modified on

2015 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name