UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of intravitreal injection of methotrexate for intraocular lymphoma
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroshi Takase
Organization	Tokyo Medical and Dental University
Division name	Department of Ophthalmology & Visual Science
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	Hiroshi Takase
Organization	Tokyo Medical and Dental University
Division name	Department of Ophthalmology & Visual Science
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
Institute	Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2007 Year 11 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025309