Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Intravitreal injection

• Registration Number: NCT01342159
• Lead Sponsor: Hallym University Medical Center

Brief Summary

One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects

Detailed Description

Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-12
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Last Update Submitted: 2011-04-26
• Study First Posted: 2011-04-27
• Last Update Posted: 2011-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )

Exclusion Criteria

• history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)
• an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
• systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)
• major surgery within the prior 6 months or planned within the next 28 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravitreal bevacizumab injection	Intravitreal injection	-
Intravitreal Triamcinolone injection	Intravitreal injection	-
intravitreal bavacizumab with triamcinolone	Intravitreal injection	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	baseline, 1 month, 3 months, 6month, 9 month, 12 month

Secondary Outcome Measures

Name	Time	Method
Central macular thickness	baseline, 1 month, 3 months, 6 months, 12months	analyzed by optical coherence tomography

Trial Locations

Locations (1)

JiWon Lim; 🇰🇷 Chuncheon, Korea, Republic of