Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetic Macular Edema
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Locations
- 1
- Primary Endpoint
- Visual acuity
- Last Updated
- 19 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Visual acuity
Central macular thickness
Secondary Outcomes
- Cataract progression
- Intraocular pressure
- Anterior chamber reaction