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

Primary Purpose

Diabetic Macular Edema

Status

Unknown status

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Triamcinolone, Bevacizumab

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal bevacizumab, Intravitreal triamcinolone, Macular thickness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hamid Ahmadieh, MD

Outcomes

Primary Outcome Measures

Visual acuity

Central macular thickness

Secondary Outcome Measures

Cataract progression

Intraocular pressure

Anterior chamber reaction

Full Information

NCT ID

NCT00370422

First Posted

August 30, 2006

Last Updated

March 12, 2007

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00370422

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2005

Overall Recruitment Status

Unknown status

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal bevacizumab, Intravitreal triamcinolone, Macular thickness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Triamcinolone, Bevacizumab

Primary Outcome Measure Information:

Title

Visual acuity

Title

Central macular thickness

Secondary Outcome Measure Information:

Title

Cataract progression

Title

Intraocular pressure

Title

Anterior chamber reaction

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Ahmadieh, MD

Organizational Affiliation

Ophthalmic Research Center of Shaheed Beheshti Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamid Ahmadieh, MD

City

Tehran

ZIP/Postal Code

16666

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

17917738

Citation

Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, Soheilian M, Keshavarzi G, Mohebbi MR. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2008 Apr;246(4):483-9. doi: 10.1007/s00417-007-0688-0. Epub 2007 Oct 5.

Results Reference

derived

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

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