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Completed

NCT Number: NCT01342159

Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

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

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Key information

Conditions

Diabetic Macular Edema

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JiWon Lim

Chuncheon, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Visual acuity

    Time frame: baseline, 1 month, 3 months, 6month, 9 month, 12 month

Secondary outcomes

  1. Central macular thickness

    Time frame: baseline, 1 month, 3 months, 6 months, 12months

    analyzed by optical coherence tomography

Sponsors and collaborators

Lead sponsor

Hallym University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2011
Registry last updated
Apr 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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