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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
  Purpose

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


Condition Intervention
Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity
 Procedure: intravitreal injection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • best corrected visual acuity [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • central macular thickness by optical coherence tomography [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months 12months ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053858

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

No publications provided

ClinicalTrials.gov Identifier: NCT01053858     History of Changes
Other Study ID Numbers: 2009_10_12
Study First Received: January 14, 2010
Last Updated: January 20, 2010
Health Authority: Korea: Food and Drug Administration

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
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013