- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370422
Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
March 12, 2007 updated by: Shahid Beheshti University of Medical Sciences
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of, 16666
- Hamid Ahmadieh, MD
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Visual acuity
|
Central macular thickness
|
Secondary Outcome Measures
Outcome Measure |
---|
Intraocular pressure
|
Anterior chamber reaction
|
Cataract progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
August 30, 2006
First Submitted That Met QC Criteria
August 30, 2006
First Posted (Estimate)
August 31, 2006
Study Record Updates
Last Update Posted (Estimate)
March 13, 2007
Last Update Submitted That Met QC Criteria
March 12, 2007
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Triamcinolone
Other Study ID Numbers
- 8412 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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