Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
January 20, 2010 updated by: Hallym University Medical Center
To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anyang
-
Chuncheon, Anyang, Korea, Republic of, 135-060
- keoung ik Na
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: triamcinolone
|
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
|
|
Active Comparator: bevacizumab
intravitreal bevacizumab or triamcinolone determined by single physician
|
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
best corrected visual acuity
Time Frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months
|
baseline, 1 month, 2 months, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
central macular thickness by optical coherence tomography
Time Frame: baseline, 1 month, 2 months, 3 months, 6 months 12months
|
baseline, 1 month, 2 months, 3 months, 6 months 12months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
January 14, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 22, 2010
Last Update Submitted That Met QC Criteria
January 20, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009_10_12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.