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Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT01342159
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : April 27, 2011
Sponsor:
Information provided by:
Hallym University Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Intravitreal injection Not Applicable

Detailed Description:
Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
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.


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

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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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
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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
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Korea, Republic of
JiWon Lim
Chuncheon, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
More Information
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Responsible Party: Hallym Medical Center
ClinicalTrials.gov Identifier: NCT01342159    
Other Study ID Numbers: IVBITA
20090321 ( Other Identifier: Hallym Medical Center )
First Posted: April 27, 2011    Key Record Dates
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:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases