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| Sponsored by: |
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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | January 2008 |
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 |
hospital-based ophtalmologic clinic
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Avraham Ishay, MD | 97246495556 | ishay_av@clalit.org.il |
| Contact: Rafael Luboshitzky, MD | 97245553 | luboshitzky_r@clalit.org.il |
| Israel | |
| Haemek Medical Center | Recruiting |
| Afula, Israel, 18101 | |
| Principal Investigator: Avraham Ishay, MD | |
| Principal Investigator: | Avraham Ishay, MD | Haemek Medical Center , Endocrine Institute |
More Information
| Study ID Numbers: | 002507EMC |
| Study First Received: | November 18, 2007 |
| Last Updated: | November 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00561236 |
| Health Authority: | Israel: Ethics Commission |
|
Triamcinolone Acetonide Triamcinolone Neoplasm Metastasis |
Triamcinolone diacetate Epinephrine Triamcinolone hexacetonide |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions |
