UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005014 |
|---|---|
| Receipt number | R000005964 |
| Scientific Title | Intravitreal bevacizumab injection versus subtreshold grid laser treatment for recurrent macular edema secondary to branch retinal vein occlusion |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2011/02/03 16:48:41 |
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Basic information
Public title
Intravitreal bevacizumab injection versus subtreshold grid laser treatment for recurrent macular edema secondary to branch retinal vein occlusion
Acronym
Intravitreal bevacizumab injection versus subtreshold grid laser treatment for recurrent macular edema secondary to branch retinal vein occlusion
Scientific Title
Intravitreal bevacizumab injection versus subtreshold grid laser treatment for recurrent macular edema secondary to branch retinal vein occlusion
Scientific Title:Acronym
Intravitreal bevacizumab injection versus subtreshold grid laser treatment for recurrent macular edema secondary to branch retinal vein occlusion
Region
| Europe |
Condition
Condition
Recurrent macular edema secondary to branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the effects of subthreshold grid laser treatment and intravitreal bevacizumab injection (IVBI) for the treatment of recurrent macular edema secondary to branch retinal vein occlusion.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reduction in the mean central retinal thickness evaluate on optical coherence tomography scan.
Key secondary outcomes
The mean best-corrected visual acuity changes over the follow-up and the proportion of eyes that gained at least 15 letters (approximately 3 lines) at the 12-month examination.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subthreshold grid laser treatment
Interventions/Control_2
intravitreal bevacizumab injections
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients affected by macular edema secondary to BRVO already undergone conventional grid laser photocoagulation
2. best corrected visual acuity (BCVA) between 20/400 and of 20/40 3. Central thickness greater than 250 microns on OCT
Key exclusion criteria
1. detection of retinal capillary non-perfusion more than 5 disc diameter on fluorescein angiography
coexistence of any other chorioretinal disease
2. presence of cataract or any other ocular conditions able to confound the results
3. uncontrolled systemic hypertension
4. peripheral vascular disease and history of thromboembolism, ischemic heart disease or stroke.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Francesco Bandello |
Organization
University Vita-Salute, Scientific Institute San Raffaele
Division name
Department of Ophthalmology
Zip code
Address
Via Olgettina 60. Milan, Italy, 20132
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Prof. Francesco Bandello |
Organization
University Vita-Salute, Scientific Institute San Raffaele
Division name
Department of Ophthalmology
Zip code
Address
Via Olgettina 60. Milan, Italy, 20132
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 02 | Month | 07 | 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
| 2009 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | 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
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2011 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005964
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
