AuthorisedTherapeutic confirmatory (Phase III)Interventional

A phase III, randomized, controlled, open label, no profit, single-center intervention study to compare the effect of a conservative (antithyroid drugs) and an ablative approach (radioiodine or total thyroidectomy) for the treatment of hyperthyroidism in patients with Graves’ disease and moderate-to-severe and active Graves’ Orbitopathy (GO) treated with intravenous glucocorticoids (ABLAGO Study)

This research study is for people in the UK who have Graves' disease, which causes an overactive thyroid, and also have an eye condition called Graves' Orbitopathy (GO). We want to understand which treatment approach is most effective for improving these eye symptoms. The study compares two main ways of treating the thyroid: taking anti-thyroid tablets, or having a treatment that permanently reduces thyroid activity, like radioactive iodine or an operation to remove the thyroid gland. All participants will also be receiving steroid medication for their eye condition. By comparing these methods, we hope to find out which one gives the best outcome for people's eyes 24 weeks after starting the study.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Ospedaliero Universitaria Pisana

Enrolment target

Start

19 Nov 2024

Graves' disease and Graves' orbitophaty

What is this study about?

This study focuses on people who have two related health problems: Graves' disease, which makes your thyroid gland overactive, and Graves' Orbitopathy (GO), an eye condition linked to it. The overactive thyroid can cause symptoms like weight loss, a fast heartbeat, and nervousness, while GO can lead to bulging eyes, double vision, and discomfort. Currently, there are different ways to treat an overactive thyroid, but it's not always clear which one works best for improving the eye condition, especially for those receiving steroid treatment for their eyes.

Researchers want to compare two main approaches for treating the thyroid: a 'conservative' approach using anti-thyroid tablets (like Tapazole) that you take regularly, or a 'definitive' approach that aims to permanently reduce thyroid activity. This permanent approach could be either a dose of radioactive iodine (Sodio Ioduro, I131), which shrinks the thyroid, or a surgery to completely remove the thyroid gland. All participants in this study would also be receiving intravenous (given into a vein) steroid medication, which is a common treatment for active and severe Graves' Orbitopathy.

By comparing these treatments, the study aims to see which method leads to the best improvement in the eye condition 24 weeks after starting the study. They will measure various aspects of the eyes, such as how wide the eyelids open, how much the eyes bulge, how well the eyes can move, and your vision. The findings will help doctors make better decisions about treating people with both Graves' disease and significant eye problems.

Key takeaways

Compares different thyroid treatments for Graves' disease with eye problems.
Looks at anti-thyroid tablets versus radioactive iodine or surgery.
Main goal is to see which works best for improving eye symptoms.
Study participants will also be receiving steroid treatment for their eyes.
Aims to improve future care for people with Graves' disease and eye involvement.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part. You must have been diagnosed with both Graves' disease, which causes an overactive thyroid, and an active, moderate-to-severe form of an eye condition called Graves' Orbitopathy (GO).

Crucially, you would also need to be receiving steroid medication given into a vein (intravenous glucocorticoids) for your eye condition as part of your treatment plan. The study is designed to compare thyroid treatments in people who are already getting this specific eye treatment.

There might be other health requirements or circumstances that would make someone unsuitable for the study, which your doctor would discuss with you. Always talk to your healthcare team to understand if this study is a good fit for your individual situation.

Quick self-check

Are you 18 years old or older?
Do you have Graves' disease (an overactive thyroid)?
Do you have moderate-to-severe Graves' Orbitopathy (eye disease)?
Are you currently receiving steroids into a vein for your eye condition?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of the treatment groups: either continuing with anti-thyroid tablets (like Tapazole) or undergoing a more permanent treatment like radioactive iodine or thyroid surgery. You would continue to receive your intravenous steroid treatment for your eye condition as planned. Throughout the study, you would have regular appointments where a doctor, who specialises in eyes, will examine your eyes to check for any changes. This will involve measuring things like how wide your eyelids are, how much your eyes bulge, how well they move, and your vision using a standard eye chart.

These assessments will happen at specific times, with a key check-up 24 weeks after you join the study, to see how well the treatment is working for your eye condition. The exact number of visits, tests, and follow-ups will be explained in detail by the study team. The overall duration you would be actively involved in the study and having these assessments tracked would be at least 24 weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit here is contributing to our understanding of which thyroid treatment works best for Graves' eye disease, potentially improving care for others in the future. You might also receive close monitoring of your condition. However, there's no guarantee that the treatment you receive in the study will be more effective for you personally than standard care. Potential risks depend on the treatment assigned; for example, radioactive iodine has risks associated with radiation exposure, and surgery has risks like infection and anaesthesia complications. Anti-thyroid drugs can have side effects. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is Graves' disease?

Graves' disease is an autoimmune condition where your immune system mistakenly attacks your thyroid gland, making it produce too many hormones, leading to an 'overactive' thyroid.

What is Graves' Orbitopathy (GO)?

GO is an eye condition that can occur with Graves' disease, causing inflammation and swelling behind the eyes, which can lead to bulging eyes, double vision, and discomfort.

What does 'randomized' mean?

It means you would be put into a treatment group by chance, like flipping a coin, to ensure a fair comparison between the different treatments.

What are 'anti-thyroid drugs'?

These are medications, usually tablets, that reduce the amount of thyroid hormone your body produces, helping to control an overactive thyroid.

What is 'radioactive iodine'?

This is a treatment where you take a small dose of iodine containing radiation. The thyroid gland absorbs it, which then slowly shrinks the gland and reduces hormone production.