View clinical trials related to Scleritis.
Filter by:This is a study of visual outcomes in retinal disease that seeks to identify the causes of visual loss. This data will be used to predict which patients are at risk of losing vision and how they can be better treated.
Background: Autoimmune scleritis is an inflammatory disease that affects the white outer part of the eye. It is associated with immune system disorders like rheumatoid arthritis. It can cause blindness in severe cases. Most treatments for scleritis involve steroid or immune-suppressing drugs, but these can cause side effects in the whole body. Sirolimus is a drug used to help prevent transplant rejection. It helps prevent the immune system from attacking the body. Researchers want to try giving sirolimus injections into the eye to treat severe scleritis. Objectives: To see if sirolimus is a safe and effective treatment for autoimmune scleritis. Eligibility: Individuals at least 18 years of age with autoimmune scleritis in at least one eye that has not responded to standard treatments. Design: - Participants will be screened with a medical history, physical exam, and eye exam. Blood and urine samples will also be collected. - One eye will be selected as the study eye to receive injections. - Participants will have six study visits over 4 months (initial visit and weeks 2, 4, 8, 12, and 16). The injection will be given at the first visit. If the study eye responds to the treatment, participants may have injections in the other eye at the second visit. - If there is still inflammation after the first injection, or if the scleritis improves but then returns, participants may have a second injection at Week 4. - Injections will be monitored with blood tests and eye exams. - Participants may have study visits and injections for up to 1 year if the injections seem to be working.
This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued. Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.
This protocol will enable IRB (institutional review board) review of proposed research using human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096. Data and samples may include demographic and personal health information, psychological or psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical and physiological evaluation and medical imaging. Data and sample analyses are limited to those approved under the original protocols unless additional specific institutional review board approval is obtained.
The purpose of this study is to assess the safety and tolerability of Rituximab in refractory scleritis and non-infectious orbital inflammation.
To evaluate the safety of an orally administered single dose of PSI-697 in subjects with scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a combination of part human and part mouse proteins that block a natural body protein called tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action may help reduce the inflammation in the disease. The drug has been approved by the Food and Drug Administration for treating Crohn's disease and rheumatoid arthritis. Patients 18 years of age or older with active non-infectious scleritis may be eligible for this study. Participants will undergo the following tests and procedures: - Medical history and physical examination. - Eye examination, including a vision test and examination of the retina (back part of the eye) and of the sclera and its blood vessels. - Questionnaire about vision and daily activities. - Tuberculin skin test. - Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0, 14, 30, 38, and 46. - Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a vein, usually in the arm. The patient's vital signs are checked before the patient begins each infusion starts and again before leaving the clinic. After the first two infusions, if the disease remains quiet, other scleritis medications will be attempted to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if the patient continues to do well. Patients receive a maximum of 9 infusions over a 30-week period. - Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number and types of cells in the blood and to check for signs of inflammation and side effects of the study medicine. Patients are seen in the NEI clinic for infusions and to check the response to therapy. This includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks, every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16 additional weeks. Patients may stop therapy if their scleritis is not controlled 10 weeks into the study period; if they develop a flare of inflammation after initial control of the active scleritis; if their vision loss is too large; or if their medications increase or other medicines are added to control the scleritis. Patients whose vision decreases minimally, stays the same, or improves may remain in the study.