Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

Secondary Adrenal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561236
• Other study ID #: 002507EMC
• Status: Completed
• Phase: N/A
• First received: November 18, 2007
• Last updated: September 7, 2016
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

• patients receiving steroids in any form, except by intravitreous administration

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Secondary Adrenal Insufficiency

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,