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Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT00370422
Recruitment Status : Unknown
Verified October 2005 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2006
Last Update Posted : March 13, 2007
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Triamcinolone, Bevacizumab Phase 3

Detailed Description:
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : November 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema




Primary Outcome Measures :
  1. Visual acuity
  2. Central macular thickness

Secondary Outcome Measures :
  1. Cataract progression
  2. Intraocular pressure
  3. Anterior chamber reaction


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

Exclusion Criteria:

  • Monocularity,
  • History of vitrectomy,
  • Glaucoma or ocular hypertension,
  • Significant media opacity,
  • Existence of traction on the macula

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): NCT00370422


Locations
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Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00370422     History of Changes
Other Study ID Numbers: 8412
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: October 2005
Keywords provided by Shahid Beheshti University of Medical Sciences:
Cystoid macular edema
Diabetic macular edema
Hard exudates
Intravitreal bevacizumab
Intravitreal triamcinolone
Macular thickness
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bevacizumab
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action