Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Edema
Intervention: Triamcinolone, Bevacizumab (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Shaheed Beheshti Medical University Official(s) and/or principal investigator(s):
Hamid Ahmadieh, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
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.
Clinical Details
Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Visual acuityCentral macular thickness
Secondary outcome: Cataract progressionIntraocular pressure Anterior chamber reaction
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hamid Ahmadieh, MD, Tehran 16666, Iran, Islamic Republic of
Additional Information
Starting date: November 2005
Ending date: September 2006
Last updated: March 12, 2007
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