Use of Thalidomide in Chronic Uveitis
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Cincinnati
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Need for corticosteroids to control eyes
Study Overview
Brief Summary
This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.
Detailed Description
Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24.
The purpose of this research study is to see if Thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.
Exclusion Criteria
- •You will not participate in this research study if any of the following apply to you:
- •If you are a man or woman not willing to take adequate birth control measures comply with FDA-mandated S.T.E.P.S.â program. .
- •If you are a breast feeding woman
- •If you have a significant peripheral neuropathy (numbness or tingling in your hands or feet)
- •Have had a recent blood clot in your leg or lungs
- •If you are currently receiving biphosphonates such as zoledronic acid (fosamax)
Outcomes
Primary Outcomes
Need for corticosteroids to control eyes
Global assessment of ocular status
Secondary Outcomes
- Toxicity