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NCT Number: NCT01219205

Major and Macular Branched Retinal Venous Occlusion

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.

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ji Won Lim

Chuncheon, Gangwon-do, 200-704, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravitreal bevacizumab

Procedure

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.

Primary outcomes

  1. efficacy of intravitreal bevacizumab

    Time frame: baseline and 12 months after initial injection

    the number on intravitreal bevacizumab during follow-up

Secondary outcomes

  1. cytokine levels in aqueous humor

    Time frame: before intravitreal injection

    cytokine levels in aqueous humor before bevacizumab injection

Sponsors and collaborators

Lead sponsor

Hallym University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 13, 2010
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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