Major and Macular Branched Retinal Venous Occlusion
Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion
1 other identifier
interventional
46
1 country
1
Brief Summary
Although it is important in the clinical management to classify BRVO into subtypes based on the location of the occlusion (major or macular), few studies have provided such information\[8,9\]. The aim of this study was to evaluate the outcome of patients with macular edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Typical duration 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
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 10, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedOctober 13, 2010
October 1, 2010
11 months
October 10, 2010
October 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of intravitreal bevacizumab
the number on intravitreal bevacizumab during follow-up
baseline and 12 months after initial injection
Secondary Outcomes (1)
cytokine levels in aqueous humor
before intravitreal injection
Study Arms (2)
major branched retinal venous occlusion
ACTIVE COMPARATORmacular branched retinal venous occlusion
ACTIVE COMPARATORInterventions
Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ㎖) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.
Eligibility Criteria
You may qualify if:
- macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm
You may not qualify if:
- previous vitreoretinal surgery, intravitreal injections or laser treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ji Won Lim
Chuncheon, Gangwon-do, 200-704, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ji Won Lim, Prof
Hallym Medical center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2010
First Posted
October 13, 2010
Study Start
March 1, 2008
Primary Completion
February 1, 2009
Study Completion
August 1, 2010
Last Updated
October 13, 2010
Record last verified: 2010-10