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Search / Trial NCT03066076

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

Launched by MEDICAL UNIVERSITY OF VIENNA · Feb 22, 2017

Trial Information

Current as of April 28, 2025

Unknown status

Keywords

ClinConnect 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 out...

Gender

ALL

Eligibility 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

About Medical University Of Vienna

The Medical University of Vienna is a leading research institution dedicated to advancing healthcare through innovative clinical research and education. Renowned for its commitment to excellence in medical science, the university fosters interdisciplinary collaboration among researchers, clinicians, and academic professionals. Its clinical trials encompass a wide range of medical disciplines, aiming to develop cutting-edge therapies and improve patient outcomes. With state-of-the-art facilities and a strong emphasis on ethical standards, the Medical University of Vienna is at the forefront of transforming scientific discoveries into practical applications that enhance global health.

Locations

Vienna, , Austria

Patients applied

0 patients applied

Trial Officials

Philipp Riss, MD

Principal Investigator

Medical University Vienna

Guido Dorner, MD

Principal Investigator

Medical University Vienna

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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