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Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

This study has been completed.
Information provided by (Responsible Party):
avraham ishay, HaEmek Medical Center, Israel Identifier:
First received: November 18, 2007
Last updated: September 7, 2016
Last verified: September 2016
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.

Secondary Adrenal Insufficiency

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:

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

Enrollment: 28
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospital-based ophtalmologic clinic

Inclusion Criteria:

  • patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

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

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

Responsible Party: avraham ishay, Dr, HaEmek Medical Center, Israel Identifier: NCT00561236     History of Changes
Other Study ID Numbers: 002507EMC 
Study First Received: November 18, 2007
Last Updated: September 7, 2016
Health Authority: Israel: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016