Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) versus Anti-Thyroid Drugs (ATD) in Patients with Moderate-to-Severe Graves’ Ophthalmopathy - a 1-year Follow-up

Phase 1

• Conditions: Graves' disease, hyperthyroidism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-003515-38-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 6 months
4) GO treatment with glucocorticoids based on the Kahaly scheme
5) thyroid surgery indications: autoimmune disease in patients with/without diffuse or (multi)nodular goiter
6) patients under ATD with normal thyroid function or latent hyperthyroid function and moderate-to-severe GO
7) clinically active inflammation according to CAScore (>3/7)
8) informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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) age below 18 years
15) no informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified