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NCT01835132 · ClinicalTrials.gov registry record · Phase 1
Gevokizumab for Active Scleritis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01835132 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 8 participants.
The verdict
NCT01835132, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: \- Scleritis is the inflammation of the white outer coating of the eye, known as the sclera. In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen. More severe scleritis may need oral steroids or immunosuppressive treatments; however, these treatments can cause side effects in the whole body. Gevokizumab is a newer anti-inflammatory drug that is under investigation to treat other inflammatory diseases. It may not have as severe side effects as some other drugs. However, it has not yet been used to treat scleritis. Researchers want to see if it can be given as a safe and effective treatment for scleritis. Objectives: \- To see if gevokizumab is a safe and effective treatment for scleritis. Eligibility: \- Individuals at least 18 years of age who have active scleritis. Design: * There is an initial phase and a two-part extension phase in this study. The extension phase is optional. The initial phase of the study requires seven visits to the National Eye Institute (NEI). * Participants will be screened with a physical exam and eye exam, and medical history will be obtained. Blood and urine samples will be collected. * Eligible participants will receive an injection of 60 mg of gevokizumab at the first study visit and at Weeks 4, 8, and 12. They will be given under the skin by the stomach, or in the upper arm or thigh. * Participants will have additional visits after the first study visit at Weeks 2, 16, and 28. No injection will be given at these visits. Eye exams will be done, and blood and tear samples will be collected. * If the scleritis improves by Week 16, participants may choose to continue the study in the extension phase. In the 1st extension, they will have a visit every 4 weeks until Week 36 and then two additional monitoring visits at Weeks 40 and 52 for a total of 13 study visits. * Participants who are eligible
Interventions
- DEVICE Gevokizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01835132
The ClinicalTrials.gov registry entry for NCT01835132 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gevokizumab is the first listed.
NCT01835132 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01835132 about?
NCT01835132 is a clinical study titled "Gevokizumab for Active Scleritis". Background: \- Scleritis is the inflammation of the white outer coating of the eye, known as the sclera. In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen. More severe...
What is the current status of trial NCT01835132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-03. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01835132?
The interventions under investigation include: Gevokizumab (DEVICE).
Who is sponsoring clinical trial NCT01835132?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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