Back to resultsRetinal Sensitivity in BRVO After Anti-VEGF Therapy
Primary Purpose
Branch Retinal Vein Occlusion
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab and laser
Sponsored by
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion
Eligibility Criteria
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.
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.
Sites / Locations
- Department of Ophthalmology, Fukushima Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ranibizumab
Ranibizumab and laser
Arm Description
After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
Outcomes
Primary Outcome Measures
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)
Secondary Outcome Measures
Full Information
NCT ID
NCT02527733
First Posted
June 29, 2015
Last Updated
August 17, 2015
Sponsor
Fukushima Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02527733
Brief Title
Retinal Sensitivity in BRVO After Anti-VEGF Therapy
Official Title
Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fukushima Medical University
4. Oversight
5. Study Description
Brief Summary
The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
Arm Title
Ranibizumab and laser
Arm Type
Active Comparator
Arm Description
After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab and laser
Primary Outcome Measure Information:
Title
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akira Ojima, M.D., Ph.D
Phone
+81-24-548-2111
Email
ao@fmu.ac.jp
Facility Information:
Facility Name
Department of Ophthalmology, Fukushima Medical University
City
Fukushima
ZIP/Postal Code
9601295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Ojima, M.D., Ph.D
Phone
+81-24-548-2111
Email
ao@fmu.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Retinal Sensitivity in BRVO After Anti-VEGF Therapy
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