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Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT00476918
Recruitment Status : Unknown
Verified May 2007 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
Sponsor:
Information provided by:
Heidelberg University

May 21, 2007
May 22, 2007
May 22, 2007
July 2006
Not Provided
Visual acuity, no of treatments, duration of efficacy [ Time Frame: 12 months ]
Same as current
No Changes Posted
intraocular pressure, retinal thickness [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema
Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
  • Diabetic Retinopathy
  • Diabetic Macular Edema
Drug: Intravitreal injection (triamcinolone acetonide)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2007
Not Provided

Inclusion Criteria:

  • diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria:

  • recent treatment with laser photocoagulation or intravitreal drugs
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00476918
21091968
Insurance no.: 20-770-968594
Yes
Not Provided
Not Provided
Not Provided
Heidelberg University
Not Provided
Study Director: Jost Jonas, PhD MD Dep of Ophthalmology, University of Mannheim
Heidelberg University
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP