Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00561236
First received: November 18, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 18, 2007
November 18, 2007
April 2007
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No Changes Posted
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Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function
Low Dose (1mcg ) ACTH Stimulation Test for Assessment of the Hypothalamo- Pituitary- Adrenal Axis in Patients Treated With Intravitreal Injection of Triamcinolone Acetonide

The use of intravitreal corticosteroids in the management ocular inflammatory diseases has recently gained widespread acceptance. The purpose of this study is to determine if the use of intravitreal triamcinolone is associated with suppression of endogenous cortisol production, as generally admitted for patients treated with oral or parenteral corticosteroid therapy.

The normalcy of hypothalamic- pituitary- adrenal axis (HPA axis) of enrolled subjects will will be assessed before intravitreal injection of 4mg of triamcinolone and again after one day, one week and two weeks. Patients with abnormal HPA axis will be re-tested after four weeks and later until the HPA axis function return to normal. The HPA axis will be assessed with low dose (1mcg) intravenous corticotropin(ACTH) stimulation test, in which cortisol levels will be sampled before , 30 minutes and 60 minutes after 1mcg ACTH IV injection.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

hospital-based ophtalmologic clinic

Secondary Adrenal Insuffisency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2008
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Inclusion Criteria:

  • patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

  • patients receiving steroids in any form, except by intravitreous administration
Both
18 Years to 75 Years
No
Contact: Avraham Ishay, MD 97246495556 ishay_av@clalit.org.il
Contact: Rafael Luboshitzky, MD 97245553 luboshitzky_r@clalit.org.il
Israel
 
NCT00561236
002507EMC
No
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HaEmek Medical Center, Israel
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Principal Investigator: Avraham Ishay, MD Haemek Medical Center , Endocrine Institute
HaEmek Medical Center, Israel
November 2007

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