UnknownPhase 3

A Conservative vs an Ablative Approach for Treatment of Hyperthyroidism in Patients With Graves' Orbitopathy

Italy52 participantsStarted 2023-03-02

Plain-language summary

Graves' disease (GD) is the most frequent cause of hyperthyroidism in iodine sufficient countries and Graves' orbitopathy (GO) is its most common extrathyroidal manifestation. Restoration and maintenance of euthyroidism are imperative in Graves' disease patients with GO. The main treatment options for Graves' hyperthyroidism are antithyroid drugs, radioactive iodine (RAI), and surgery. Whether one or the other therapy for Graves' hyperthyroidism offers the best protection against GO is not established. The study is aimed at comparing the effects of a conservative approach (antithyroid drugs, ATDs, experimental arm) vs an ablative approach (radioiodine or total thyroidectomy) of thyroid treatment on the overall outcome of GO in patients with GD and moderate-to-severe and active GO treated with intravenous glucocorticoids.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients willing and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
✓. A diagnosis of Graves' disease based on the presence of hyperthyroidism associated with detectable anti-thyrotropic hormone (TSH) receptor autoantibodies (TRAb). Patients must be euthyroid under control on stable medical regimen and every effort will be made to maintain the euthyroid status for the entire duration of the clinical trial.
✓. Duration of Graves' disease shorter than 18 months
✓. A moderate-to-severe GO, defined as the presence of at least one of the following criteria in the most affected eye: an exophthalmos ≥2 mm compared with normal values for sex and race; presence of inconstant to constant diplopia; a lid retraction ≥2 mm
✓. Active GO: CAS ≥ 3 out of 7 points in the most affected eye. Taking into account severity (moderate-to-severe) and activity (CAS ≥ 3/7) of GO, patients are eligible for methylprednisolone treatment according to clinical practice.
✓. Duration of GO shorter than 18 months
✓. Male and female patients of age 18-75 years
✓. Compliant patient, regular follow-up possible

Exclusion criteria

What they're measuring

Overall GO outcome

Timeframe: 24 weeks

Trial details

NCT IDNCT04776993

SponsorUniversity of Pisa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

Contact for this trial

Michele Marino

+39050997346 michele.marino@med.unipi.it

View on ClinicalTrials.gov More Graves' Orbitopathy trials