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Major and Macular Branched Retinal Venous Occlusion

NCT ID: NCT01219205

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-08-31

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.

Conditions

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Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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major branched retinal venous occlusion

Group Type ACTIVE_COMPARATOR

intravitreal bevacizumab

Intervention Type 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.

macular branched retinal venous occlusion

Group Type ACTIVE_COMPARATOR

intravitreal bevacizumab

Intervention Type 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.

Interventions

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intravitreal bevacizumab

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hallym Medical center

Principal Investigators

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Ji Won Lim, Prof

Role: STUDY_CHAIR

Hallym Medical center

Locations

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Ji Won Lim

Chuncheon, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2009_128

Identifier Type: -

Identifier Source: org_study_id