UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005604 |
|---|---|
| Receipt number | R000006623 |
| Scientific Title | Evaluation of intravitreal injection of Rituximab for intraocular lymphoma |
| Date of disclosure of the study information | 2011/05/15 |
| Last modified on | 2022/11/23 11:19:12 |
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Basic information
Public title
Evaluation of intravitreal injection of Rituximab for intraocular lymphoma
Acronym
Evaluation of intravitreal injection of Rituximab for intraocular lymphoma
Scientific Title
Evaluation of intravitreal injection of Rituximab for intraocular lymphoma
Scientific Title:Acronym
Evaluation of intravitreal injection of Rituximab for intraocular lymphoma
Region
| Japan |
Condition
Condition
intraocular lymphoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of intravitreal injection of Rituximab for intraocular lymphoma.
To investigate if the site of ocular lesions and prophylactic treatment in patients with primary vitreoretinal lymphoma (PVRL) are associated with the time to onset of central nervous system (CNS) involvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
best-corrected visual acuity, intraocular pressure, indirect ophthalmoscopy, and slit-lamp examination before and after every treatment
Key secondary outcomes
We also evaluated whether prophylactic treatment of systemic chemotherapy such as high-dose methotrexate (HD-MTX) and intrathecal MTX (IT-MTX) or topical ocular treatments such as intravitreal injections of MTX and rituximab inhibited the onset of CNS involvement in patients with PVRL without cerebral involvement.
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
Intravitreal injection of Rituximab
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
All patients had a history of biopsy-proven CD20-positive intraocular lymphoma that had been treated with repeated intravitreal injection of methotrexate; however, all patients discontinued treatment because of severe corneal epitheliopathy.
Key exclusion criteria
The patients who has history of myocardial infarction and brain infarction.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyasu |
| Middle name | |
| Last name | Hashida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
567-0871
Address
2-2 Yamadaoka, Suita city
TEL
06-6879-3456
nhashida@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyasu |
| Middle name | |
| Last name | Hashida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
567-0871
Address
2-2 Yamadaoka, Suita city
TEL
06-6879-3456
Homepage URL
nhashida@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2 E7, Yamada-oka
Tel
+81668793456
nhashida@ophthal.med.osaka-u.ac.jp
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
| 2011 | Year | 05 | Month | 15 | 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
Completed
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 11 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
