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Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema

H

Hallym University

Status

Completed

Conditions

Diabetic Macular Edema

Treatments

Procedure: Intravitreal injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01342159
IVBITA
20090321 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment

80 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 3 patient groups

Intravitreal bevacizumab injection
Active Comparator group
Treatment:
Procedure: Intravitreal injection
Intravitreal Triamcinolone injection
Active Comparator group
Treatment:
Procedure: Intravitreal injection
intravitreal bavacizumab with triamcinolone
Active Comparator group
Treatment:
Procedure: Intravitreal injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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