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Status unknownNCT03066076Updated Feb 28, 2017

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

A Phase 3 interventional study of Antithyroid Drug and Total thyroidectomy in Graves Disease, Graves Ophthalmopathy and Graves' Ophthalmopathy Worsened, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Medical University of Vienna · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Graves Disease
  • Graves Ophthalmopathy
  • Graves' Ophthalmopathy Worsened
03

In context

Graves Disease

150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 92 interventional studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Thyroidectomy

    Total thyroidectomy

    Drug: Antithyroid Drug

  • Active comparator
    Antithyroid drug

    Thiamazol, Propylthiouracil

    Procedure: Total thyroidectomy

Interventions

  • DrugAntithyroid Drug

    Antithyroid drug

    Also known as: Thiamazol, Propylthiouracil

  • ProcedureTotal thyroidectomy

    Operation

06

What researchers measure

Primary outcomes

  1. Muscle index (MI) from ultrasound measurements

    Muscle index (MI) from ultrasound measurements

    Time frame: 12 months

  2. Thyroid antibodies

    Thyroid antibodies

    Time frame: 12 months

Secondary outcomes

  1. CAScore/NOSPECS score

    CAScore/NOSPECS score

    Time frame: 12 months

  2. Superonasal index measurements via ultrasound

    Superonasal index measurements via ultrasound

    Time frame: 12 months

  3. Quality of life score

    Quality of life score

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Department of Surgery and Department of Ophthalmology Medical University Vienna
    Vienna, 1090, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No IPD sharing

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03066076
Lead sponsor
Medical University of Vienna
Responsible party
Philipp Riss (Professor, Medical University of Vienna) — Principal investigator
First posted
Feb 28, 2017
Start date
Mar 1, 2017 (estimated)
Primary completion
Feb 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Feb 28, 2017

Study contacts

Lindsay Brammen, MD
Contact
lindsay.brammen@meduniwien.ac.at
+4314040056210
Philipp Riss, MD
Contact
philipp.riss@meduniwien.ac.at
+4314040056210
Philipp Riss, MD
principal investigator · Medical University Vienna
Guido Dorner, MD
principal investigator · Medical University Vienna

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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