A Phase 3 interventional study of Methimazole and Radioiodine or thyroidectomy in Graves' Orbitopathy, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by University of Pisa · Phase 3, Interventional, and Treatment
Among 11 studies in Graves Ophthalmopathy by University of Pisa — 4 open to participants now, 4 under way, 2 of them phase 3. Graves Ophthalmopathy · University of Pisa.
Among the 11 studies in Graves Ophthalmopathy by University of Pisa, this one is one of 2 that started in 2023, is one of 2 in phase 3, and was the 9th registered.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 52 is below the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →4 of the 11 studies in Graves Ophthalmopathy by University of Pisa are open now, in 1 country. Each count lists the studies.
Of the 38 Graves Ophthalmopathy studies recruiting now, 8 (21%) set no upper age limit and 16 (42%) stop at 75 or younger; 1 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2023.
Median enrollment 88 across the 5 interventional studies, 65 across the 6 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Graves Ophthalmopathy by University of Pisa, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antithyroid drugs (at individualized dosage) for 72 weeks and a cumulative dose of 4.5 g of methylprednisolone divided into 12 weekly infusions
Drug: Methimazole
Radioiodine therapy or total thyroidectomy (according to ultrasound thyroid volume) and a cumulative dose of 4.5 g of methylprednisolone divided into 12 weekly infusions
Procedure: Radioiodine or thyroidectomy
Methimazole for 72 weeks
Also known as: MMI
Treatment with radioiodine or with thyroidectomy
Also known as: Thyroid ablation
Overall GO outcome
Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline): * Improvement in CAS by at least 2 points * Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) * Improvement in lid aperture by at least 2 mm * Improvement in diplopia (disappearance or change in the degree) * Improvement of visual acuity by at least 0.2/1 Patients meeting the improvement criteria will be considered as "responders". All other patients will be considered as "non-responders".
Time frame: 24 weeks
Overall GO outcome
Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline): * Improvement in CAS by at least 2 points * Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) * Improvement in lid aperture by at least 2 mm * Improvement in diplopia (disappearance or change in the degree) * Improvement of visual acuity by at least 0.2/1 Patients meeting the improvement criteria will be considered as "responders". All other patients will be considered as "non-responders".
Time frame: 48 weeks
Overall GO outcome
Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline): * Improvement in CAS by at least 2 points * Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) * Improvement in lid aperture by at least 2 mm * Improvement in diplopia (disappearance or change in the degree) * Improvement of visual acuity by at least 0.2/1 Patients meeting the improvement criteria will be considered as "responders". All other patients will be considered as "non-responders".
Time frame: 72 weeks
Response of individual GO parameters: proptosis, CAS, eyelid width, diplopia, and visual acuity
Improvement is defined as change in each of the following outcome measures in at least one eye, without deterioration in both eyes (compared to baseline): * Improvement in CAS by at least 2 points * Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) * Improvement in lid aperture by at least 2 mm * Improvement in diplopia (disappearance or change in the degree) * Improvement of visual acuity by at least 0.2/1 Patients meeting the improvement criteria will be considered as "responders". All other patients will be considered as "non-responders".
Time frame: 24, 48 and 72 weeks
Quality of life questionnaire
Comparison of a disease specific quality of life questionnaire (GO-QoL) at 24, 48 and 72 weeks. Positive response: an improvement in the questionnaire by at least 6/48 points. The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance. The minimal clinically important difference in scores is ≥ 10 points for invasive therapies, but a change of 6 is already perceived by patients as beneficial and is associated with an important change in daily functioning. The GO-QoL is well validated, widely used, and available in eight languages. The GO-QoL is recommended as an independent outcome measure in randomized clinical trials24.
Time frame: 24, 48 and 72 weeks
Plan to share: No
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Studies of the drug tested here: Methimazole