Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

September 7, 2016 updated by: avraham ishay, HaEmek Medical Center, Israel

Low Dose (1mcg ) ACTH Stimulation Test for Assessment of the Hypothalamo- Pituitary- Adrenal Axis in Patients Treated With Intravitreal Injection of Triamcinolone Acetonide

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospital-based ophtalmologic clinic

Description

Inclusion Criteria:

  • patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Avraham Ishay, MD, Haemek Medical Center , Endocrine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 18, 2007

First Submitted That Met QC Criteria

November 18, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002507EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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