UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021943
Receipt number R000025309
Scientific Title A pilot study of intravitreal injection of methotrexate for intraocular lymphoma
Date of disclosure of the study information 2016/04/20
Last modified on 2016/05/02 19:23:38

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Basic information

Public title

A pilot study of intravitreal injection of methotrexate for intraocular lymphoma

Acronym

A pilot study of intravitreal injection of methotrexate for intraocular lymphoma

Scientific Title

A pilot study of intravitreal injection of methotrexate for intraocular lymphoma

Scientific Title:Acronym

A pilot study of intravitreal injection of methotrexate for intraocular lymphoma

Region

Japan


Condition

Condition

Intraocular lymphoma

Classification by specialty

Ophthalmology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims at investigating the efficacy and safety of intravitreal injection of methotrexate to establish more effective therapy for intraocular lymphoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Remission of the intraocular lesions, visual acuity, cytokine levels in intraocular fluids, and recurrence rate in two years.

Key secondary outcomes

Rate of adverse events, and relapse rate (central nerve system and other lesion)


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

Perform intravitreal MTX (400 ug/100 ul) injection weekly for the eyes that were diagnosed as intraocular lymphoma until the lymphoma lesions are resolved.

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

A. Patients of intraocular lymphoma diagnosed according to the following criteria:
1) positive for characteristic ocular symptoms and findings of lymphoma
2) pathologically diagnosed as lymphoma
3) positive for IgH gene clonality detected by PCR assay or flow cytometry
1 with 2 or 3
B. Patients whose written informed consent can be obtained.

Key exclusion criteria

(1) Eyes with severe intraocular infectious disease
(2) History of serious adverse reactions by methotrexate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Takase

Organization

Tokyo Medical and Dental University

Division name

Department of Ophthalmology & Visual Science

Zip code


Address

1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan

TEL

+81-3-5803-5302

Email

h.takase.oph@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Takase

Organization

Tokyo Medical and Dental University

Division name

Department of Ophthalmology & Visual Science

Zip code


Address

1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan

TEL

+81-3-5803-5302

Homepage URL


Email

h.takase.oph@tmd.ac.jp


Sponsor or person

Institute

Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 04 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Date of protocol fixation

2007 Year 11 Month 05 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 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

2016 Year 04 Month 17 Day

Last modified on

2016 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name