Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function

NCT ID: NCT00561236

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Adrenal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients receiving intravitreous injection of triamcinolone 4mg

Exclusion Criteria

* patients receiving steroids in any form, except by intravitreous administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

avraham ishay

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Avraham Ishay, MD

Role: PRINCIPAL_INVESTIGATOR

Haemek Medical Center , Endocrine Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haemek Medical Center

Afula, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002507EMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.