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Trial record 18 of 8408 for:    Ophthalmopathy

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

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ClinicalTrials.gov Identifier: NCT03066076
Recruitment Status : Unknown
Verified February 2017 by Philipp Riss, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Philipp Riss, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Graves Disease Graves Ophthalmopathy Graves' Ophthalmopathy Worsened Drug: Antithyroid Drug Procedure: Total thyroidectomy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Observer blinded analysis
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thyroidectomy
Total thyroidectomy
Drug: Antithyroid Drug
Antithyroid drug
Other Names:
  • Thiamazol
  • Propylthiouracil

Active Comparator: Antithyroid drug
Thiamazol, Propylthiouracil
Procedure: Total thyroidectomy
Operation




Primary Outcome Measures :
  1. Muscle index (MI) from ultrasound measurements [ Time Frame: 12 months ]
    Muscle index (MI) from ultrasound measurements

  2. Thyroid antibodies [ Time Frame: 12 months ]
    Thyroid antibodies


Secondary Outcome Measures :
  1. CAScore/NOSPECS score [ Time Frame: 12 months ]
    CAScore/NOSPECS score

  2. Superonasal index measurements via ultrasound [ Time Frame: 12 months ]
    Superonasal index measurements via ultrasound

  3. Quality of life score [ Time Frame: 12 months ]
    Quality of life score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066076


Contacts
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Contact: Lindsay Brammen, MD +4314040056210 lindsay.brammen@meduniwien.ac.at
Contact: Philipp Riss, MD +4314040056210 philipp.riss@meduniwien.ac.at

Locations
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Austria
Department of Surgery and Department of Ophthalmology Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Lindsay Brammen, MD    +4314040056210    lindsay.brammen@meduniwien.ac.at   
Contact: Philipp Riss, MD    +4314040056210    philipp.riss@meduniwien.ac.at   
Principal Investigator: Philipp Riss, MD         
Principal Investigator: Guido Dorner, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Philipp Riss, MD Medical University Vienna
Principal Investigator: Guido Dorner, MD Medical University Vienna

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Responsible Party: Philipp Riss, Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03066076     History of Changes
Other Study ID Numbers: 1839/2015
2015-003515-38 ( EudraCT Number )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing

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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

Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Genetic Diseases, Inborn
Propylthiouracil
Antithyroid Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs