Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO
CRVO
Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)
1 other identifier
interventional
30
1 country
1
Brief Summary
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 16, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedMarch 19, 2014
March 1, 2014
2.4 years
March 16, 2014
March 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Best-corrected visual acuity
12 months
Study Arms (1)
Intravitreal injection of Ranibizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Macular edema associated with central retinal vein occlusion
- Best corrected visual acuity \< 20/30
- Central macular thickness \> 300
- Period from symptom onset to treatment \< 12 months
You may not qualify if:
- Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mie Universitylead
Study Sites (1)
Mie University Hospital
Tsu, Aichi-ken, 514-8507, Japan
Related Publications (2)
Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9.
PMID: 20381871BACKGROUNDBhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
PMID: 23415775BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mineo Kondo, MD, PhD
Mie University Hospital
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
- MD. PhD.
Study Record Dates
First Submitted
March 16, 2014
First Posted
March 19, 2014
Study Start
December 1, 2013
Primary Completion
May 1, 2016
Last Updated
March 19, 2014
Record last verified: 2014-03