Clinical Trial: Gevokizumab for Active Scleritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition (GATSBY)
Brief 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.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline [ Time Frame: Baseline and Week 2 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline [ Time Frame: Baseline and Week 4 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline [ Time Frame: Baseline and Week 8 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline [ Time Frame: Baseline and Week 12 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline [ Time Frame: Baseline and Week 16 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline [ Time Frame: Baseline and Week 20 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline [ Time Frame: Baseline and Week 24 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline [ Time Frame: Baseline and Week 28 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline [ Time Frame: Baseline and Week 32 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline [ Time Frame: Baseline and Week 36 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
- Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline [ Time Frame: Baseline and Week 40 ]Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen
Original Secondary Outcome: Changes in visual acuity, intraocular pressure, and in scleral grading. [ Time Frame: 16 weeks ]
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: April 16, 2013
Date Started: March 2013
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016
Detailed Summary:
Objective: Scleritis is a chronic, painful and potentially blinding inflammatory disease characterized by edema of the episcleral and sclera tissues and is commonly associated with systemic autoimmune disorders. Gevokizumab is an interleukin-1β (IL-1β) inhibitor, thus possibly preventing the IL-1β that may be responsible for scleral breakdown in patients with anterior scleritis. The study objective is to evaluate the safety and potential efficacy of gevokizumab as a possible treatment of non-infectious, active, anterior scleritis.
Study Population: Ten participants with non-infectious, active, anterior scleritis with a scleral inflammatory grade of ≥ +1 in at least one eye were to be initially enrolled. However, only eight participants were enrolled. Participants may be on ≤ 20 mg/day of prednisone or the equivalent at the time of enrollment but all other immunosuppressive drugs will be stopped with the initiation of study drug.
Design: This is a Phase 1/2, open label, non-randomized, prospective, single-arm, pilot trial to evaluate the safety and potential efficacy of gevokizumab in non-infectious, active, anterior scleritis. The study consists of an initial phase followed by a two-part extension phase. For the initial phase, all participants will receive one subcutaneous injection of 60 mg gevokizumab at Baseline and Weeks 4, 8 and 12. At Week 16 of the initial phase, participants will be assessed for eligibility in the first extension phase of the study. Participants from the initial phase, who do not continue in the first extension phase of the study will discontinue the study drug and may receive salvage therapy using standard-of-care treatment at the investigator's discretion. Participants from the initial phase who do not continue in the first extension phase will return for a final safety
Sponsor: National Eye Institute (NEI)
Current Primary Outcome: Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit. [ Time Frame: Baseline and Week 16 ]
Original Primary Outcome: Number of participants with > =2-step reduction or reduction to 0 in scleral inflammation in the study eye (or eyes, if both eyes meet study eye criteria), on or before the Week 16 visit as compared to Baseline. [ Time Frame: 13 weeks ]
Current Secondary Outcome:
