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

This study is ongoing, but not recruiting participants.

First Received: August 30, 2006 Last Updated: March 12, 2007 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370422

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

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.

Eligibility

Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370422

Locations

Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Hamid Ahmadieh, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided by Shaheed Beheshti Medical University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, Soheilian M, Keshavarzi G, Mohebbi MR. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2008 Apr;246(4):483-9. Epub 2007 Oct 5.

Study ID Numbers:	8412
Study First Received:	August 30, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00370422 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Cystoid macular edema
Diabetic macular edema
Hard exudates

Intravitreal bevacizumab
Intravitreal triamcinolone
Macular thickness

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses

Triamcinolone
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010