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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
  Purpose

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.


Condition
Secondary Adrenal Insuffisency

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Low Dose (1mcg ) ACTH Stimulation Test for Assessment of the Hypothalamo- Pituitary- Adrenal Axis in Patients Treated With Intravitreal Injection of Triamcinolone Acetonide

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Study Completion Date: January 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospital-based ophtalmologic clinic

Criteria

Inclusion Criteria:

  • patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

  • patients receiving steroids in any form, except by intravitreous administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561236

Contacts
Contact: Avraham Ishay, MD 97246495556 ishay_av@clalit.org.il
Contact: Rafael Luboshitzky, MD 97245553 luboshitzky_r@clalit.org.il

Locations
Israel
Haemek Medical Center Recruiting
Afula, Israel, 18101
Principal Investigator: Avraham Ishay, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Avraham Ishay, MD Haemek Medical Center , Endocrine Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00561236     History of Changes
Other Study ID Numbers: 002507EMC
Study First Received: November 18, 2007
Last Updated: November 18, 2007
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013