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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

7 criteria

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 trial?

9 criteria

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.

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Region Skane Skanes Universitetssjukhus
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Lund, Sweden

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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.

What is already known about the treatment

Diclofenac
Diclofenac is typically administered orally in tablet form or applied topically as a gel or cream. It is a well-known medication in the medical field, primarily used for its anti-inflammatory and pain-relieving properties. In the context of this clinical trial, it is being evaluated for its effectiveness in treating Graves' ophthalmopathy, a condition affecting the eyes. Diclofenac works by inhibiting the production of substances in the body that cause inflammation and pain, specifically targeting enzymes known as cyclooxygenases. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).
Simvastatin
Simvastatin is usually taken orally in tablet form. It is widely recognized in medicine for its role in lowering cholesterol levels and reducing the risk of cardiovascular disease. In this clinical trial, simvastatin is being investigated for its potential benefits in treating Graves' ophthalmopathy, a condition that affects the eyes. Simvastatin works by blocking an enzyme in the liver that is responsible for making cholesterol, which may also have anti-inflammatory effects. It belongs to a class of drugs known as statins.

Investigated diseases

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.