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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00370422
• Collaborator: (none)
• Location: 1
• Duration (Months): 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Triamcinolone, Bevacizumab	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2005
• Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Visual acuity []

2. Central macular thickness []

Secondary Outcome Measures

1. Cataract progression []

2. Intraocular pressure []

3. Anterior chamber reaction []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamid Ahmadieh, MD	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Hamid Ahmadieh, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00370422
• Other Study ID Numbers: 8412
• First Posted: Aug 31, 2006
• Last Update Posted: Mar 13, 2007
• Last Verified: Oct 1, 2005

• Keywords provided by , ,: Cystoid macular edema; Diabetic macular edema; Hard exudates; Intravitreal bevacizumab; Intravitreal triamcinolone; Macular thickness
• Additional relevant MeSH terms: Macular Edema; Edema; Triamcinolone; Bevacizumab

Study Results

No Results Posted as of Mar 13, 2007