Diabetic Macular Edema
Conditions
Keywords
Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal bevacizumab, Intravitreal triamcinolone, Macular thickness
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.
Interventions
DRUGTriamcinolone, Bevacizumab
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | — |
| Central macular thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| Cataract progression | — |
| Intraocular pressure | — |
| Anterior chamber reaction | — |
Countries
Iran
Outcome results
None listed