Major and Macular Branched Retinal Venous Occlusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion

Conditions
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Macular Edema

Intervention / Treatment
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* Procedure: intravitreal bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: major branched retinal venous occlusion<br> | Procedure: intravitreal bevacizumab<br>* 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.<br>|
| Active Comparator: macular branched retinal venous occlusion<br> | Procedure: intravitreal bevacizumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of intravitreal bevacizumab | the number on intravitreal bevacizumab during follow-up | baseline and 12 months after initial injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine levels in aqueous humor | cytokine levels in aqueous humor before bevacizumab injection | before intravitreal injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema secondary to retinal benous occlusion