We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342159
First Posted: April 27, 2011
Last Update Posted: April 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hallym University Medical Center
  Purpose
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

Condition Intervention
Diabetic Macular Edema Procedure: Intravitreal injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: baseline, 1 month, 3 months, 6month, 9 month, 12 month ]

Secondary Outcome Measures:
  • Central macular thickness [ Time Frame: baseline, 1 month, 3 months, 6 months, 12months ]
    analyzed by optical coherence tomography


Enrollment: 80
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravitreal bevacizumab injection 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.
Active Comparator: Intravitreal Triamcinolone injection 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.
Active Comparator: intravitreal bavacizumab with triamcinolone 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.

Detailed Description:
Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342159


Locations
Korea, Republic of
JiWon Lim
Chuncheon, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
  More Information

Responsible Party: Hallym Medical Center
ClinicalTrials.gov Identifier: NCT01342159     History of Changes
Other Study ID Numbers: IVBITA
20090321 ( Other Identifier: Hallym Medical Center )
First Submitted: April 25, 2011
First Posted: April 27, 2011
Last Update Posted: April 27, 2011
Last Verified: March 2009

Keywords provided by Hallym University Medical Center:
bevacizumab, diabetic macular edema, triamcinolone

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action