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Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

Primary Purpose

Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity

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

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity focused on measuring bevacizumab,triamcinolone, intravitreal injection

Eligibility Criteria

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

Inclusion Criteria:

  • central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

Exclusion Criteria:

  • previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
  • Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
  • neovascularization on the disc or elsewhere or rubeosis

Sites / Locations

  • keoung ik Na

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bevacizumab

triamcinolone

Arm Description

intravitreal bevacizumab or triamcinolone determined by single physician

Outcomes

Primary Outcome Measures

best corrected visual acuity

Secondary Outcome Measures

central macular thickness by optical coherence tomography

Full Information

First Posted
January 14, 2010
Last Updated
January 20, 2010
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01053858
Brief Title
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
Keywords
bevacizumab,triamcinolone, intravitreal injection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Active Comparator
Arm Description
intravitreal bevacizumab or triamcinolone determined by single physician
Arm Title
triamcinolone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intravitreal injection
Intervention Description
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
Primary Outcome Measure Information:
Title
best corrected visual acuity
Time Frame
baseline, 1 month, 2 months, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
central macular thickness by optical coherence tomography
Time Frame
baseline, 1 month, 2 months, 3 months, 6 months 12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion Exclusion Criteria: previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders neovascularization on the disc or elsewhere or rubeosis
Facility Information:
Facility Name
keoung ik Na
City
Chuncheon
State/Province
Anyang
ZIP/Postal Code
135-060
Country
Korea, Republic of

12. IPD Sharing Statement

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Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

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