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Major and Macular Branched Retinal Venous Occlusion

Primary Purpose

Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intravitreal bevacizumab
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring macular edema secondary to retinal benous occlusion

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ji Won Lim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

major branched retinal venous occlusion

macular branched retinal venous occlusion

Arm Description

Outcomes

Primary Outcome Measures

efficacy of intravitreal bevacizumab
the number on intravitreal bevacizumab during follow-up

Secondary Outcome Measures

cytokine levels in aqueous humor
cytokine levels in aqueous humor before bevacizumab injection

Full Information

First Posted
October 10, 2010
Last Updated
October 12, 2010
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01219205
Brief Title
Major and Macular Branched Retinal Venous Occlusion
Official Title
Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
macular edema secondary to retinal benous occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
major branched retinal venous occlusion
Arm Type
Active Comparator
Arm Title
macular branched retinal venous occlusion
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intravitreal bevacizumab
Intervention Description
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 Outcome Measure Information:
Title
efficacy of intravitreal bevacizumab
Description
the number on intravitreal bevacizumab during follow-up
Time Frame
baseline and 12 months after initial injection
Secondary Outcome Measure Information:
Title
cytokine levels in aqueous humor
Description
cytokine levels in aqueous humor before bevacizumab injection
Time Frame
before intravitreal injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Won Lim, Prof
Organizational Affiliation
Hallym Medical center
Official's Role
Study Chair
Facility Information:
Facility Name
Ji Won Lim
City
Chuncheon-si
State/Province
Kangwon-do
ZIP/Postal Code
200-704
Country
Korea, Republic of

12. IPD Sharing Statement

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Major and Macular Branched Retinal Venous Occlusion

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