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Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

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ClinicalTrials.gov Identifier: NCT00561236
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
avraham ishay, HaEmek Medical Center, Israel

Brief Summary:
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 or disease
Secondary Adrenal Insufficiency

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.

Study Type : Observational
Actual Enrollment : 28 participants
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
Study Start Date : April 2007
Primary Completion Date : December 2007
Study Completion Date : January 2008






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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00561236


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

Responsible Party: avraham ishay, Dr, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00561236     History of Changes
Other Study ID Numbers: 002507EMC
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
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