UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015826 |
|---|---|
| Receipt number | R000018282 |
| Scientific Title | Intravitreal ranibizumab for the treatment of cystoid macular edema in central retinal vein occlusion with good visual acuity by PRN, phase 2 trial. |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2017/05/03 11:02:39 |
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Basic information
Public title
Intravitreal ranibizumab for the treatment of cystoid macular edema in central retinal vein occlusion with good visual acuity by PRN, phase 2 trial.
Acronym
Intravitreal ranibizumab for the treatment of cystoid macular edema in central retinal vein occlusion by PRN.
Scientific Title
Intravitreal ranibizumab for the treatment of cystoid macular edema in central retinal vein occlusion with good visual acuity by PRN, phase 2 trial.
Scientific Title:Acronym
Intravitreal ranibizumab for the treatment of cystoid macular edema in central retinal vein occlusion by PRN.
Region
| Japan |
Condition
Condition
Central retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of PRN therapy of intravitreal ranibizumab for the cystoid macular edema in central retinal vein occlusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
ETDRS chart and the change from the baseline at 12 months after injection.
Key secondary outcomes
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
Ranibizumab 0.5 mg/0.05 ml
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study eye Snellen equivalent BCVA of 20/20 to 20/400.
Mean central subfoveal thickness over 0.250mm.
Key exclusion criteria
Juvenile central retinal vein occlusion.
Hemi central retinal vein occlusion.
History of cerebral infarction or myocardial infarction.
History of vitrectomy.
History or presence of age-related macular degeneration or diabetic retinopathy.
Previous use of subtenon injection of corticosteroids, intravitreal injection of anti-VEGF drugs or panretinal photocoaguration within 4 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Manabe |
Organization
Nihon university hospital
Division name
department of ophthalmology
Zip code
Address
1-6, Kanda Surugadai, Chiyodaku, Tokyo
TEL
0332931711
ayumu.m76@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Manabe |
Organization
Nihon universty hospital
Division name
Department of ophthalmology
Zip code
Address
1-6, Kanda Surugadai, Chiyodaku, Tokyo
TEL
0332931711
Homepage URL
ayumu.m76@gmail.com
Sponsor or person
Institute
Department of ophthalmology of nihon university hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
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
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | 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
| 2014 | Year | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018282
