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
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
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
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
