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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetic Macular Edema Drug: Intravitreal injection (triamcinolone acetonide) Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema
Study Start Date : July 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources




Primary Outcome Measures :
  1. Visual acuity, no of treatments, duration of efficacy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. intraocular pressure, retinal thickness [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00476918


Contacts
Contact: Ulrich HM Spandau, PhD MD +496213832242 ulrich.spandau@augen.ma.uni-heidelberg.de
Contact: Anne Wickenhaeuser, MD +496213832242 anne.wickenhäuser@augen.ma.uni-heidelberg.de

Locations
Germany
Dep of Ophthalmology, University of Mannheim Recruiting
Mannheim, Germany, 68167
Principal Investigator: Ulrich HM Spandau, PhD MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Study Director: Jost Jonas, PhD MD Dep of Ophthalmology, University of Mannheim

ClinicalTrials.gov Identifier: NCT00476918     History of Changes
Other Study ID Numbers: 21091968
Insurance no.: 20-770-968594
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: May 22, 2007
Last Verified: May 2007

Keywords provided by Heidelberg University:
diabetic macular edema
triamcinolone acetonide
intravitreal
steroid

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action