Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

This study has been completed.

Sponsor:

Information provided by:

Hallym University Medical Center

ClinicalTrials.gov Identifier:

NCT01053858

First received: January 14, 2010

Last updated: January 20, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 14, 2010
Last Updated Date	January 20, 2010
Start Date ^ICMJE	January 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 2010)	best corrected visual acuity [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01053858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 20, 2010)	central macular thickness by optical coherence tomography [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months 12months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
Intervention ^ICMJE	Procedure: intravitreal injection intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection
Study Arm (s)	Active Comparator: bevacizumab intravitreal bevacizumab or triamcinolone determined by single physician Intervention: Procedure: intravitreal injection Active Comparator: triamcinolone Intervention: Procedure: intravitreal injection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	38
Completion Date	January 2010
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01053858
Other Study ID Numbers ^ICMJE	2009_10_12
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Hallym University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hallym University Medical Center
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top