Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

This study is currently recruiting participants.

Verified by HaEmek Medical Center, Israel, November 2007

First Received: November 18, 2007 No Changes Posted

Sponsor:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00561236

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:	Case-Only, 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:

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Triamcinolone diacetate
Glucocorticoids

Hormones
Immunosuppressive Agents
Pharmacologic Actions
Triamcinolone hexacetonide
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone

ClinicalTrials.gov processed this record on February 08, 2010