UMIN-CTR Clinical Trial

Basic information
Public title	Retinal sensitivity in branch retinal vein occlusion after anti-VEGF therapy
Acronym	Retinal sensitivity in BRVO after anti-VEGF therapy
Scientific Title	Retinal sensitivity in branch retinal vein occlusion after anti-VEGF therapy
Scientific Title:Acronym	Retinal sensitivity in BRVO after anti-VEGF therapy
Region	Japan

Condition
Condition	Branch retinal vein occlusion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the changes in retinal sensitivity after ranibizumab therapy or combination theraphy of ranibizumab and laser photocoagulation in eyes with branch retinal vein occlusion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Retinal sensitivity at 12 months
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Ranibizumab (Lucentis) intravitreal injection is performed at baseline. Measurement of the best corrected visual acuity and foveal thickness using optical coherence tomography are performed monthly. Ranibizumab (Lucentis) intravitreal injection is performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
Interventions/Control_2	Ranibizumab (Lucentis) intravitreal injection is performed at baseline. Measurement of the best corrected visual acuity and foveal thickness using optical coherence tomography are performed monthly. Ranibizumab (Lucentis) intravitreal injection is performed when visual acuity is less than 1.0 and foveal thickness is more than 250micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250micrometers at month 3 and month 9.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.
Key exclusion criteria	Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection or severe inflammation will be excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Ojima
Organization	Fukushima Medical University
Division name	Department of Ophthalmology
Zip code
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-548-2111
Email	ao@fmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akira Ojima
Organization	Fukushima Medical University
Division name	Department of Ophthalmology
Zip code
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-548-2111
Homepage URL
Email	ao@fmu.ac.jp

Sponsor
Institute	Department of Ophthalmology, Fukushima Medical University
Institute
Department

Funding Source
Organization	Novartis Pharmaceuticals Japan
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 06 Month 19 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	2015 Year 06 Month 19 Day
Date of IRB	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 18 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019516