UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021943
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
URL(English) https://upload.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


Contact us.