Clinical Trials for Uveitis: Current Research and Treatment Options
Five clinical trials are currently investigating new treatment approaches for uveitis, an inflammatory eye condition. These studies are testing various medications including adalimumab, baricitinib, izokibep, and methotrexate across multiple European countries. The trials focus on both adult and pediatric patients with different forms of non-infectious uveitis, aiming to find more effective ways to control inflammation and reduce dependency on steroids.
Clinical trial locations
- Austria
- Czechia
- France
- Germany
- Italy
- Spain
- Study of Baricitinib and Adalimumab for Children Aged 2 to 17 with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
- Study on Izokibep for Patients with Non-infectious Uveitis
- Study on Methotrexate and Adalimumab for Non-Infectious Uveitis in Patients: Evaluating Effectiveness and Safety
Study Comparing Adalimumab and Mycophenolate Mofetil for Patients with Steroid-Dependent Non-Infectious Uveitis
This trial is comparing two different treatments for people with non-infectious uveitis who depend on steroid medications. The study focuses on patients whose eye inflammation requires ongoing steroid use and compares adalimumab, given as an injection under the skin, with mycophenolate mofetil, taken as a daily tablet.
Who can participate: Adults aged 18 and older with a confirmed diagnosis of non-infectious intermediate, posterior, or pan-uveitis are eligible. Participants must have experienced recent active inflammation in the last three months despite taking more than 7 mg of oral prednisone daily. A recent chest X-ray or CT scan showing no active tuberculosis, infection, or cancer is required. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control throughout the study.
Who cannot participate: People with other eye diseases that could affect the study results, those who have had recent eye surgery, anyone with an active infection, pregnant or breastfeeding women, those with a history of severe allergic reactions to the study medications, people currently in another clinical trial, those with drug or alcohol abuse history, and anyone with serious medical conditions that could affect their safety are excluded.
What the study involves: The trial runs for 36 weeks and aims to see which treatment better controls eye inflammation and reduces the need for steroids. Adalimumab is given as an 80 mg injection on the first day, followed by 40 mg every two weeks. Mycophenolate mofetil is taken as 2 grams daily by mouth. Researchers will monitor participants’ eye health, including visual acuity, inflammation levels, and retinal thickness at regular intervals.
Study of Baricitinib and Adalimumab for Children Aged 2 to 17 with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
This trial is specifically designed for children and teenagers with eye inflammation related to juvenile idiopathic arthritis or chronic anterior uveitis with positive antinuclear antibodies. The study is testing the safety and effectiveness of baricitinib, a medication taken by mouth.
Who can participate: Children aged 2 to 17 years with a diagnosis of juvenile idiopathic arthritis-associated uveitis or chronic anterior antibody-positive uveitis can join. Participants must have active anterior uveitis that persists despite adequate treatment with steroid eye drops and methotrexate. They must either not respond well to or be unable to tolerate methotrexate. Participants need to be using a stable dose of corticosteroid eye drops for at least two weeks before starting, with no more than four drops per day per eye. Those of childbearing age and their partners must agree to use two effective birth control methods during the study.
Who cannot participate: Children outside the age range of 2 to 17 years, those without the specific types of uveitis being studied, anyone unable to take oral medication, those with medical conditions that might interfere with the study, pregnant or breastfeeding participants, those in other clinical trials, people with allergic reactions to similar drugs, those with serious infections or health issues, and anyone unable to follow study procedures are excluded.
What the study involves: The treatment involves taking baricitinib tablets orally, with the dosage determined by the child’s age and medical condition. The study monitors how well the medication reduces eye inflammation over 24 weeks, with regular assessments including eye examinations and safety checks. The research continues until July 2028.
Study on Izokibep for Patients with Non-infectious Uveitis
This trial is testing a new medication called izokibep for treating non-infectious inflammation affecting the middle, back, or entire eye. The study compares izokibep injections with a placebo to determine how well it works in controlling eye inflammation.
Who can participate: Adults aged 18 to 75 years with non-infectious intermediate, posterior, or pan-uveitis are eligible. Participants must have active disease with inflammatory lesions visible on eye imaging despite taking a stable dose of oral corticosteroids for at least two weeks. They must have shown an inadequate response to adalimumab or be unable to take it for medical reasons. All participants need a negative tuberculosis test at screening, and women must use birth control and have a negative pregnancy test.
Who cannot participate: People with active infections, those who have had recent surgery or are planning surgery, pregnant or breastfeeding women, anyone with a history of severe allergic reactions to medications, those currently in another clinical trial, people with unrelated eye conditions, those who have recently used certain medications that might affect results, anyone with drug or alcohol abuse history, and people with certain medical conditions that could affect safety are excluded.
What the study involves: Participants receive either izokibep or placebo through subcutaneous injections. The study lasts up to 52 weeks with regular monitoring to assess treatment effectiveness. The main goal is to evaluate how long patients can go without treatment failure between weeks 10 and 52. Researchers monitor vision changes, retinal thickness, inflammation levels, and any side effects throughout the study period.
Study on Methotrexate and Adalimumab for Non-Infectious Uveitis in Patients: Evaluating Effectiveness and Safety
This Spanish trial is comparing three different treatment approaches for non-infectious uveitis: methotrexate alone, adalimumab alone, or a combination of both medications. The study aims to determine which option is most effective in managing eye inflammation.
Who can participate: Adults aged 18 years and older with non-infectious uveitis in at least one eye are eligible. Participants must have had at least one episode of active inflammation in the past 180 days and show active inflammation at the study start. This can include active retinal or vascular lesions, macular edema, inflammation cells in the front of the eye, or cloudiness in the vitreous. Participants must meet specific criteria related to chronic condition, bilateral disease with vision problems, or steroid-resistant inflammation. Women must either be unable to have children or agree to use birth control during the study and for 150 days after the last dose. All participants need negative tuberculosis testing and normal chest X-rays.
Who cannot participate: People with infectious eye conditions, those who have had eye surgery in the last three months, anyone using certain interfering medications, those with other serious health conditions, pregnant or breastfeeding women, those who participated in another trial within 30 days, people with drug or alcohol abuse history, and anyone unable to follow study procedures are excluded.
What the study involves: Participants are randomly assigned to one of three groups receiving methotrexate orally, adalimumab by intramuscular injection, or both medications combined. The study lasts 52 weeks with regular visits to monitor treatment response. The main goal is to achieve a good clinical response by week 16 that continues until week 52. Assessments include eye examinations, tests evaluating treatment effectiveness and safety, and monitoring for side effects.
Study on the Effectiveness of Baricitinib for Patients with Refractory Non-Infectious Uveitis
This French trial is studying baricitinib for people whose non-infectious non-anterior uveitis has not improved with other advanced treatments. The study focuses on difficult-to-treat cases that have failed to respond to two different types of biologic therapy.
Who can participate: Adults under 65 years old with non-infectious non-anterior uveitis that remains active or requires at least 10 mg of corticosteroids daily despite trying two biotherapies (anti-TNF alpha and tocilizumab) are eligible. Participants must stop using biotherapy and other immune-affecting medications for at least 10 days before joining. They must be part of a social security plan and able to understand and sign the consent form. Women of childbearing potential must use effective birth control for at least four weeks before starting, during the study, and for one week after stopping treatment, and have a negative pregnancy test. Participants need negative tests for latent tuberculosis within the last six months, a normal chest X-ray within three months, and recent tests showing no active HIV, hepatitis C, or hepatitis B infections.
Who cannot participate: Anyone with active non-anterior non-infectious uveitis who has not tried at least two biotherapy treatments (anti-TNF alpha and tocilizumab) cannot participate. The study specifically focuses on patients who have already tried these treatments without success.
What the study involves: Participants take baricitinib tablets orally, either 2 mg or 4 mg doses, along with prednisone tablets as needed. The study lasts six months with assessments at one month, three months, and six months. These evaluations include measuring visual acuity, inflammation levels in different parts of the eye, and retinal thickness using specialized imaging. The primary goal is to determine if baricitinib can help achieve partial remission of the condition at six months while potentially reducing the need for steroids.
Summary
These five clinical trials represent current research efforts to improve treatment options for various forms of uveitis across Europe. France is leading with three trials, while other countries including Germany, Spain, Italy, Austria, and Czechia are also participating in multiple studies. The trials show particular interest in testing baricitinib and adalimumab, with three studies investigating these medications either alone or in combination with other treatments.
The research spans different patient populations, including both adults and children, and addresses various types of non-infectious uveitis from steroid-dependent cases to difficult-to-treat forms that have not responded to conventional therapies. Most studies emphasize reducing dependency on steroids while maintaining effective control of eye inflammation. The trials typically run between six months and several years, with the longest expected to conclude in 2028.
All studies require careful screening for tuberculosis and other infections before participation, and women of childbearing potential must use effective contraception. These trials offer hope for people living with uveitis, particularly those who have struggled to find effective treatments or wish to reduce their reliance on steroid medications.
