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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005014
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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