Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion
Study on the Correlation Between the Treatment Effectiveness of Ranibizumab and the Role of the Cytokines in Macular Edema With Retinal Vein Occlusion
1 other identifier
interventional
100
1 country
2
Brief Summary
The purpose of this study is to evaluate the efficacy of intravitreal ranibizumab by determining the pathogenesis of macular edema, which cause a direct effect on visual function. In particular, we focus on the correlation between the treatment effectiveness of ranibizumab and the role of the cytokines involved in the cause of macular edema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 23, 2014
June 1, 2014
2 years
June 13, 2014
June 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual function by ranibizumab in macular edema with retnal vein occlusion
Mean change in central retinal thickness (CRT) and best corrected visual acuity (BCVA) at month 12
one year
Secondary Outcomes (1)
Cytokine levels by ranibizumab in macular edema with retnal vein occlusion
one year
Study Arms (1)
ranibizumab
EXPERIMENTALExperimental: Intravitreal injection of Ranibizumab
Interventions
intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
Eligibility Criteria
You may qualify if:
- Foveal thickness \> 300 μm
- Best corrected visual acuity \< 20/30
You may not qualify if:
- History of retinal diseases other than BRVO, glaucoma, uveitis, diabetes mellitus, rubeosis iridis, ocular infections, laser photocoagulation, and intraocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hachioji Medical Center, Tokyo Medical University
Tokyo, 193-0998, Japan
Hachioji Medical Center, Tokyo Medical University
Tokyo, 193-0998, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hidetaka Noma, MD
Hachioji Medical Center, Tokyo Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Ophthalmology, Hachioji Medical Center
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 23, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 23, 2014
Record last verified: 2014-06