Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Sponsor||Shahid Beheshti Medical University|
|Start date||November 2005|
|End date||September 2006|
|Trial identifier||NCT00370422, 8412|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Central macular thickness
Anterior chamber reaction
Male or female participants of any age.
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
|Principal investigator||Hamid Ahmadieh, MD|
|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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