Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
Primary Purpose
Graves Disease, Graves Ophthalmopathy, Graves' Ophthalmopathy Worsened
Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Antithyroid Drug
Total thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Graves Disease
Eligibility Criteria
Inclusion Criteria:
- GD and GO onset < 12 months
- no previous GD treatment other than antithyroid drugs (ATD)
- first relapse after decrease of antithyroid medication within 4-6 months
- GO treatment with glucocorticoids based on the Kahaly scheme
- patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
- clinically active inflammation according to CAScore (>3/7)
- informed consent
Exclusion Criteria:
- GD and GO onset > 12 months
- more than one relapse of GO longer than 6 months from diagnosis
- previous GD treatment by RAI or surgery
- SNI greater than 7.0
- urgent orbital decompression surgery
- loss of vision
- loss of visual field
- loss of color vision
- patients not receiving glucocorticoids for GO
- cytological findings of postsurgical histopathological results suspicious for malignancy
- pregnancy or breast-feeding
- contraindication to GC
- halt of GC therapy
- Patients with diabetes mellitus
- age below 18 years
- no informed consent
Sites / Locations
- Department of Surgery and Department of Ophthalmology Medical University ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thyroidectomy
Antithyroid drug
Arm Description
Total thyroidectomy
Thiamazol, Propylthiouracil
Outcomes
Primary Outcome Measures
Muscle index (MI) from ultrasound measurements
Muscle index (MI) from ultrasound measurements
Thyroid antibodies
Thyroid antibodies
Secondary Outcome Measures
CAScore/NOSPECS score
CAScore/NOSPECS score
Superonasal index measurements via ultrasound
Superonasal index measurements via ultrasound
Quality of life score
Quality of life score
Full Information
NCT ID
NCT03066076
First Posted
January 27, 2017
Last Updated
February 22, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03066076
Brief Title
Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease, Graves Ophthalmopathy, Graves' Ophthalmopathy Worsened
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Observer blinded analysis
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thyroidectomy
Arm Type
Active Comparator
Arm Description
Total thyroidectomy
Arm Title
Antithyroid drug
Arm Type
Active Comparator
Arm Description
Thiamazol, Propylthiouracil
Intervention Type
Drug
Intervention Name(s)
Antithyroid Drug
Other Intervention Name(s)
Thiamazol, Propylthiouracil
Intervention Description
Antithyroid drug
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy
Intervention Description
Operation
Primary Outcome Measure Information:
Title
Muscle index (MI) from ultrasound measurements
Description
Muscle index (MI) from ultrasound measurements
Time Frame
12 months
Title
Thyroid antibodies
Description
Thyroid antibodies
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CAScore/NOSPECS score
Description
CAScore/NOSPECS score
Time Frame
12 months
Title
Superonasal index measurements via ultrasound
Description
Superonasal index measurements via ultrasound
Time Frame
12 months
Title
Quality of life score
Description
Quality of life score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
GD and GO onset < 12 months
no previous GD treatment other than antithyroid drugs (ATD)
first relapse after decrease of antithyroid medication within 4-6 months
GO treatment with glucocorticoids based on the Kahaly scheme
patients under ATD with normal thyroid function or subclinical hyperthyroid function and moderate-to-severe GO
clinically active inflammation according to CAScore (>3/7)
informed consent
Exclusion Criteria:
GD and GO onset > 12 months
more than one relapse of GO longer than 6 months from diagnosis
previous GD treatment by RAI or surgery
SNI greater than 7.0
urgent orbital decompression surgery
loss of vision
loss of visual field
loss of color vision
patients not receiving glucocorticoids for GO
cytological findings of postsurgical histopathological results suspicious for malignancy
pregnancy or breast-feeding
contraindication to GC
halt of GC therapy
Patients with diabetes mellitus
age below 18 years
no informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Brammen, MD
Phone
+4314040056210
Email
lindsay.brammen@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Riss, MD
Phone
+4314040056210
Email
philipp.riss@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Riss, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guido Dorner, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery and Department of Ophthalmology Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Brammen, MD
Phone
+4314040056210
Email
lindsay.brammen@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Philipp Riss, MD
Phone
+4314040056210
Email
philipp.riss@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Philipp Riss, MD
First Name & Middle Initial & Last Name & Degree
Guido Dorner, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing
Learn more about this trial
Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy
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