Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

NCT01342159 | Completed DMC

• 2 other identifiers: IVBITA20090321
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema

Keywords

bevacizumab, diabetic macular edema, triamcinolone

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  baseline, 1 month, 3 months, 6month, 9 month, 12 month

Secondary Outcomes (1)

• Central macular thickness

  baseline, 1 month, 3 months, 6 months, 12months

Study Arms (3)

Intravitreal bevacizumab injection

ACTIVE COMPARATOR

Procedure: Intravitreal injection

Intravitreal Triamcinolone injection

ACTIVE COMPARATOR

Procedure: Intravitreal injection

intravitreal bavacizumab with triamcinolone

ACTIVE COMPARATOR

Procedure: Intravitreal injection

Interventions

Intravitreal injection PROCEDURE

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.

Intravitreal Triamcinolone injection; Intravitreal bevacizumab injection; intravitreal bavacizumab with triamcinolone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

JiWon Lim

Chuncheon, South Korea

Location

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 27, 2011

Record last verified: 2009-03

Locations

KR (1)