This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2005 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: August 30, 2006
Last updated: March 12, 2007
Last verified: October 2005
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 Intervention Phase
Diabetic Macular Edema Drug: Triamcinolone, Bevacizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Visual acuity
  • Central macular thickness

Secondary Outcome Measures:
  • Cataract progression
  • Intraocular pressure
  • Anterior chamber reaction

Study Start Date: November 2005
Estimated Study Completion Date: September 2006
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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00370422

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00370422     History of Changes
Other Study ID Numbers: 8412
Study First Received: August 30, 2006
Last Updated: March 12, 2007

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:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017