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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000433
Receipt No. R000000525
Scientific Title Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Date of disclosure of the study information 2006/06/30
Last modified on 2015/05/11

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Basic information
Public title Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Acronym Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Scientific Title Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Scientific Title:Acronym Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Region
Japan

Condition
Condition Patients with macular edema from branch retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Randamized clinical trial of pars plana vitrectomy and grid laser photocoagulation for patients with macular edema from branch retinal vein occlusion. Improvement of the visual outcome and foveal retinal thickness for the patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 12 months distant visual acuity
12 months foveal retinal thickness
Key secondary outcomes Course of distant visual acuity over treatment period
Course of foveal retinal thickness over treatment period
Ischemic maculopathy at 12 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group1: grid laser photocoagulation
Interventions/Control_2 Group2: pars plana vitrectomy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Participants must have center-involved macular edema secondary to branch retinal vein occlusion documented for at least 2 months and not longer 18 months

Visual acuity greater than or equal to 0.1 (logMAR1.0) and less than or equal to 0.5 (logMAR0.3)

Foveal retinal thickness greater than or equal to 250 microns of the optical coherence tomography (mean of 2 measurements).
Key exclusion criteria Ischemic maculopathy and macular degeneration

Presence of hemorrhage directly in the fovea

Additional ocular disease reducing the visual acuity

Sitting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg at the screening visit

History of systemic corticosteroids within 4 months prior to randomization

History of laser photocoaguration for macular edema

History of major ocular surgery within 6 months prior to randomization

History of peribulbar or retrobulbar or intravitreal corticosteroid use

History of pars plana vitrectomy

Aphakia

Pregnancy

History of allergy to fluorescein

uncontrollable systemic disease

participation in another trial

Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiji Sakamoto
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5402
Email tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiji Sakamoto
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5402
Homepage URL
Email tsakamot@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
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
2006 Year 06 Month 30 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 Terminated
Date of protocol fixation
2006 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 06 Month 20 Day
Last modified on
2015 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000525

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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