Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342159
• Other study ID #: IVBITA
• Secondary ID: 20090321
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: April 26, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Procedure:
• Intravitreal injection
Intravitreal Injections were done under sterile conditions with topical anesthesia and insertion of a lid speculum. For the bevacizumab group, 1.25 mg (0.05 cc) bevacizumab (Avastin, made for F. Hoffmann-La Roche Ltd Basel, Switzerland by Genentech Inc., San Francisco, CA, USA) was injected intravitreally with a 30-gauge needle through the superotemporal quadrant. For the bevacizumab with triamcinolone group, in addition to intravitreal bevacizumab, 2 mg(0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally through the inferotemporal quadrant. For triamcinolone group, 2 mg (0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally.

Locations

Country	Name	City	State
Korea, Republic of	JiWon Lim	Chuncheon

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		baseline, 1 month, 3 months, 6month, 9 month, 12 month	Yes
Secondary	Central macular thickness	analyzed by optical coherence tomography	baseline, 1 month, 3 months, 6 months, 12months	Yes