Major and Macular Branched Retinal Venous Occlusion

Not Applicable

Completed

• Conditions: Macular Edema

• Registration Number: NCT01219205
• Lead Sponsor: Hallym University Medical Center

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.

Detailed Description

Branch retinal vein occlusion is the second most frequent major retinal vascular disease after diabetic retinopathy. One of the main reasons for visual loss in BRVO is the development of macular edema. Treatment options for BRVO include grid laser treatment, intravitreal injection of steroids, surgical procedures, and off-label treatment with intravitreal anti-vascular endothelial growth factor (VEGF) agents. During recent years, intravitreal anti-VEGF treatment with bevacizumab has been shown to efficiently reduce macular edema and improve visual acuity in numerous case series and prospective or retrospective studies.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-02
• Study Completion: 2010-08
• Status Verified: 2010-10
• Study First Submitted: 2010-10-10
• Study First Submitted QC: 2010-10-12
• Last Update Submitted: 2010-10-12
• Study First Posted: 2010-10-13
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm

Exclusion Criteria

• previous vitreoretinal surgery, intravitreal injections or laser treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
efficacy of intravitreal bevacizumab	baseline and 12 months after initial injection	the number on intravitreal bevacizumab during follow-up

Secondary Outcome Measures

Name	Time	Method
cytokine levels in aqueous humor	before intravitreal injection	cytokine levels in aqueous humor before bevacizumab injection

Trial Locations

Locations (1)

Ji Won Lim; 🇰🇷 Chuncheon-si, Kangwon-do, Korea, Republic of

Ji Won Lim

🇰🇷Chuncheon-si, Kangwon-do, Korea, Republic of