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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Triamcinolone, Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00370422

8412

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind