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Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

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ClinicalTrials.gov Identifier: NCT01053858
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Sponsor:
Information provided by:
Hallym University Medical Center

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.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity Procedure: intravitreal injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Active Comparator: bevacizumab
intravitreal bevacizumab or triamcinolone determined by single physician
Procedure: intravitreal injection
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection

Active Comparator: triamcinolone Procedure: intravitreal injection
intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection




Primary Outcome Measures :
  1. best corrected visual acuity [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months ]

Secondary Outcome Measures :
  1. central macular thickness by optical coherence tomography [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months 12months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053858


Locations
Korea, Republic of
keoung ik Na
Chuncheon, Anyang, Korea, Republic of, 135-060
Sponsors and Collaborators
Hallym University Medical Center

ClinicalTrials.gov Identifier: NCT01053858     History of Changes
Other Study ID Numbers: 2009_10_12
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010

Keywords provided by Hallym University Medical Center:
bevacizumab,triamcinolone, intravitreal injection

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action