Overview

This trial is active, not recruiting.

Condition diabetic macular edema
Treatment triamcinolone, bevacizumab
Phase phase 3
Sponsor Shahid Beheshti Medical University
Start date November 2005
End date September 2006
Trial identifier NCT00370422, 8412

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Visual acuity
time frame:
Central macular thickness
time frame:

Secondary Outcomes

Measure
Cataract progression
time frame:
Intraocular pressure
time frame:
Anterior chamber reaction
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2007.
Information provided to ClinicalTrials.gov by Shahid Beheshti Medical University.