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Study on Treating Graves’ Eye Disease with Diclofenac or Simvastatin for Patients with Mild to Moderate Symptoms

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What is this study about?

This clinical trial is focused on studying the treatment of Graves’ ophthalmopathy, a condition that affects the eyes and is associated with Graves’ disease, an autoimmune disorder that impacts the thyroid. The study will explore the effects of two medications: simvastatin, a drug commonly used to lower cholesterol, and diclofenac, a non-steroidal anti-inflammatory drug (NSAID) often used to relieve pain and inflammation. Some participants will receive one of these medications, while others will not receive any additional treatment, which is known as a placebo.

The purpose of the study is to evaluate how these treatments affect the activity and progression of Graves’ ophthalmopathy in patients who have mild to moderate symptoms. Participants will be involved in the study for a period of six months. During this time, the study will monitor changes in the condition’s activity and any progression to more severe forms. The study will also assess the quality of life of participants and examine specific markers related to the disease.

Throughout the study, participants will undergo various assessments to track the effects of the treatments. These assessments will include measuring the thickness of the conjunctiva, which is the clear tissue covering the white part of the eye, using a technique called optical coherence tomography. The study aims to provide valuable insights into the management of Graves’ ophthalmopathy and potentially improve treatment options for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, symptoms of Graves’ ophthalmopathy, and thyroid health status.

The assessment ensures that the condition is mild to moderate and that the disease duration is less than 18 months.

2 treatment allocation

Participants are randomly assigned to one of three groups: diclofenac, simvastatin, or no additional treatment.

This allocation determines the course of treatment for the duration of the trial.

3 medication administration

If assigned to the diclofenac group, take the medication orally as prescribed by the study team.

If assigned to the simvastatin group, take the medication orally as prescribed by the study team.

The frequency and dosage are determined by the study protocol and communicated by the study team.

4 regular follow-up visits

Attend regular follow-up visits as scheduled by the study team. These visits occur at specific intervals to monitor progress.

During these visits, assessments are conducted to evaluate the activity of Graves’ ophthalmopathy and any changes in symptoms.

5 midpoint evaluation

At the 3-month mark, a detailed evaluation is conducted to assess changes in symptoms and overall health.

This includes measuring conjunctival thickness and other markers of eye health.

6 final evaluation

After 6 months, a final evaluation is conducted to assess the overall effectiveness of the treatment.

This includes a comprehensive review of symptoms, quality of life, and any progression to severe Graves’ ophthalmopathy.

Who Can Join the Study?

  • Age between 18 and 70 years.
  • Have active mild to moderate Graves’ ophthalmopathy (GO), which is an eye condition related to thyroid disease, with at least one sign of mild GO. This is based on a specific classification system.
  • Have exophthalmos, which means bulging eyes, up to 24 mm, and the condition should have lasted less than 18 months.
  • Have Graves’ disease, a thyroid condition, and be in a state of euthyroidism, meaning normal thyroid function, under one of the following conditions:
    • After stopping treatment with anti-thyroid drugs (ATD).
    • After at least 2 months of treatment with ATD.
    • At least 6 months after treatment with radioiodine, a type of radiation therapy.
    • After having a total thyroidectomy, which is the surgical removal of the thyroid gland.

Who Cannot Join the Study?

  • Patients with other serious eye diseases cannot participate.
  • Patients who have had eye surgery in the last 6 months are not eligible.
  • Patients who are currently using other treatments for Graves’ ophthalmopathy cannot join the study.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients with severe allergies to diclofenac or simvastatin cannot take part.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients with severe liver or kidney disease cannot participate.
  • Patients with a history of heart attack or stroke in the last year are not eligible.
  • Patients who are participating in another clinical trial are not allowed to join.

Where you can join this trial?

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Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
02.01.2018

Trial locations

Investigated drugs:

Diclofenac is a medication that is commonly used to reduce inflammation and pain. In this clinical trial, it is being tested to see if it can help manage the symptoms of Graves’ ophthalmopathy, a condition that affects the eyes. The goal is to see if diclofenac can help reduce the activity of the disease and prevent it from becoming more severe.

Simvastatin is a medication that is usually used to lower cholesterol levels in the blood. However, in this trial, it is being studied for its potential benefits in treating Graves’ ophthalmopathy. Researchers want to find out if simvastatin can help control the disease and stop it from getting worse in patients with mild to moderate symptoms.

Graves’ ophthalmopathy – Graves’ ophthalmopathy is an autoimmune condition associated with thyroid disease, where the immune system attacks the tissues around the eyes. This leads to inflammation and swelling, causing symptoms such as bulging eyes, discomfort, and redness. As the disease progresses, patients may experience increased pressure in the eye socket, leading to restricted eye movement and double vision. The condition can vary in severity, with some individuals experiencing mild symptoms while others may develop more pronounced changes. Over time, the inflammation can lead to tissue remodeling and fibrosis, potentially affecting vision. The progression of the disease can be influenced by factors such as smoking and thyroid hormone levels.

Trial ID:
2024-517833-42-00
Protocol code:
GO-DS
NCT ID:
NCT03131726
Trial Phase:
Therapeutic use (Phase IV)

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