Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy

Graves Disease Clinical Trial

Official title:

Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) Versus Thionamides (Anti-Thyroid Drugs) in Patients With Moderate-to-Severe Graves' Ophthalmopathy - a 1-year Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03066076
• Other study ID #: 1839/2015
• Secondary ID: 2015-003515-38
• Status: Recruiting
• Phase: Phase 3
• First received: January 27, 2017
• Last updated: February 22, 2017
• Start date: March 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2017
• Source: Medical University of Vienna
• Contact: Lindsay Brammen, MD
• Phone: +4314040056210
• Email: lindsay.brammen[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.

Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.

Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.

Description:

Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor (TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the extraocular muscles and an increase in retroorbital fat. There are currently three forms of therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's disease and GO.

Objective: To examine the difference in the outcome of GO in patients with moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse of GO or in which GO stays the same following the initial decrease in ATD therapy after 6 months.

Methods: This prospective randomized clinical trial with observer blinded analysis will analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery. Main outcome variables include: muscle index measurements via ultrasound and thyroid antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal index measurements via ultrasound and quality of life score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. GD and GO onset < 12 months

2. no previous GD treatment other than antithyroid drugs (ATD)

3. first relapse after decrease of antithyroid medication within 4-6 months

4. GO treatment with glucocorticoids based on the Kahaly scheme

5. patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO

6. clinically active inflammation according to CAScore (>3/7)

7. informed consent

Exclusion Criteria:

1. GD and GO onset > 12 months

2. more than one relapse of GO longer than 6 months from diagnosis

3. previous GD treatment by RAI or surgery

4. SNI greater than 7.0

5. urgent orbital decompression surgery

6. loss of vision

7. loss of visual field

8. loss of color vision

9. patients not receiving glucocorticoids for GO

10. cytological findings of postsurgical histopathological results suspicious for malignancy

11. pregnancy or breast-feeding

12. contraindication to GC

13. halt of GC therapy

14. Patients with diabetes mellitus

15. age below 18 years

16. no informed consent

Related Conditions & MeSH terms

• Eye Diseases
• Graves Disease
• Graves Ophthalmopathy
• Graves' Ophthalmopathy Worsened

Intervention

Drug:
• Antithyroid Drug
Antithyroid drug

Procedure:
• Total thyroidectomy
Operation

Locations

Country	Name	City	State
Austria	Department of Surgery and Department of Ophthalmology Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle index (MI) from ultrasound measurements	Muscle index (MI) from ultrasound measurements	12 months
Primary	Thyroid antibodies	Thyroid antibodies	12 months
Secondary	CAScore/NOSPECS score	CAScore/NOSPECS score	12 months
Secondary	Superonasal index measurements via ultrasound	Superonasal index measurements via ultrasound	12 months
Secondary	Quality of life score	Quality of life score	12 months