Uveitis Clinical Trial
Official title:
Sirolimus as a Therapeutic Approach for Uveitis: A Phase 2, Open-label, Randomized Study to Assess the Safety, Tolerability, and Bioactivity of Two Doses of Intravitreal Injection of Sirolimus in Patients With Non-infectious Uveitis
The purpose of this study is to find out about the safety and effectiveness of two different doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies. In this study, the investigators will administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or 880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.
Uveitis is a condition in which certain parts of your eye become inflamed. The inflammation is usually recurrent. If the inflammation is not treated adequately, permanent damage to the eye and to the vision may occur. The inflammation can be caused by infectious or non infectious causes. The current research is being done to determine the safety and the usefulness of treatment of non-infectious uveitis using different doses of intravitreal injections of a drug called sirolimus. Current treatment options for uveitis include oral corticosteroids and drugs that weaken the immune system of the body (i.e., immunosuppressant drugs). Treatment using oral corticosteroids, especially for long periods, may cause many undesirable side effects and complications such as high blood sugar, high blood pressure, bone weakness, obesity, stomach ulcers, abnormal hair growth, and increased risks of infection. In addition to that, in some cases, the disease cannot be controlled even with the highest dose of steroids. Injection of steroids around and inside the eye can be used to control uveitis. However, the inflammation does not always respond to such kind of treatment. The eyes may develop high pressure and cataract with injections of steroids into the eyes or around the eyes. On the other hand, despite their potential effectiveness, treatment with drugs that weaken the immune system may cause severe side effects. Increased risk of infection is a common side effect of all the immunosuppressant drugs. The immune system protects the body from infections. When the immune system is suppressed, infections are more likely to happen. Some of these infections are potentially dangerous. Because the immune system protects the body against some forms of cancer, immunosuppressant drugs are also associated with a slightly increased risk of cancer. For example, long-term use of immunosuppressant drugs may carry an increased risk of developing skin cancer as a result of the combination of the drugs and exposure to sunlight. The immunosuppressive drugs are very powerful and can cause serious side effects such as high blood pressure, kidney problems, and liver problems. Some side effects may not show up until years after the medicine is used. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Active, not recruiting |
NCT04704609 -
Imaging Quantification of Inflammation (IQI)
|
||
Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
Terminated |
NCT02907814 -
Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
|
N/A | |
Active, not recruiting |
NCT02252328 -
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
|
Phase 2/Phase 3 | |
Completed |
NCT04183387 -
Simvastatin in Uveitis
|
Phase 2 | |
Completed |
NCT01983488 -
Clinical Outcome in Uveitis
|
||
Withdrawn |
NCT00499551 -
A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis
|
Phase 1/Phase 2 | |
Terminated |
NCT00114062 -
Study to Treat Uveitis Associated Macular Edema
|
Phase 2 | |
Completed |
NCT00132691 -
Multicenter Uveitis Steroid Treatment (MUST) Trial
|
Phase 4 | |
Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
Completed |
NCT00001867 -
Effect of Pregnancy on Uveitis
|
N/A | |
Completed |
NCT00379275 -
Eye and Immunogenetic Features of Sarcoidosis
|
N/A | |
Active, not recruiting |
NCT03828019 -
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
|
Phase 3 | |
Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 | |
Active, not recruiting |
NCT03889860 -
Objective Choroidal Thickness Measurements in Uveitis
|
||
Completed |
NCT00070759 -
Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
|
Phase 2 | |
Recruiting |
NCT05486468 -
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
|
Phase 3 | |
Active, not recruiting |
NCT05385757 -
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
|
||
Active, not recruiting |
NCT06260449 -
Different Treatment Approaches of Presumed Trematode-Induced Uveitis
|
N/A |