To assess the efficacy and safety of Abatacept as an immunosuppressive treatment in Birdshot uveitis. The primary objective is to test the efficacy to suppress inflammation in active Birdshot uveitis patients, using quantitative and qualitative measurements of visual function.
To assess the efficacy and safety of Abatacept as an immunosuppressive treatment in Birdshot uveitis. The primary objective is to assess the efficacy to suppress active uveitis in Birdshot uveitis and to induce inflammatory remission during the 1 year treatment and after 2 years of treatment. Treatment efficacy will be assessed, using quantitative and qualitative measurements of visual function. In this trial we will also assess the utility of quantitative outcome measures in detecting disease activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Abatacept 125 MG/ML Prefilled Syringe \[Orencia\] weekly
UZLeuven
Leuven, Vlaams-Brabant, Belgium
time to recurrence in ≥1 eye
Patients are assessed for recurrence, if at least 1 of the following criteria are fulfilled in at least 1 eye. * worsening of BCVA (Best Corrected Visual Acuity measured by ETDRS chart) by \>15 letters relative to baseline * 30% increase of central retinal thickness on OCT (Optical Coherence Tomography) relative to baseline * 2-step increase in VH (Vitreous Haze) grade relative to baseline * new active, inflammatory choroidal (detected on ICG Angiography) and/or inflammatory retinal vascular lesions relative to baseline (detected on FA: fluorescein angiography).
Time frame: 1 year and 2 years
Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit
Vitreous haze is measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria: Grade 0: No evident vitreous haze Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.
Time frame: 1 year and 2 years
Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit
Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.
Time frame: 1 year and 2 years
Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Baseline
Optical coherence tomography is performed at every visit using the Zeiss Cirrus OCT. Images are evaluated by a central reader (PI). Macular edema is defined as cystoid macular edema. OCT evidence of macular edema on or after Baseline is to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema are to be considered as censored observations at the time of dropping out. Optical Coherence Tomography will be measured using the Zeiss Cirrus OCT. For each eye a macular cube slab 512x128 and 2 HD 5 lines rasters (1 on 180° and 1 on 90°) will be taken, centered on the fovea.
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Time frame: 1 year and 2 years
Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit
Optical coherence tomography is performed at every visit using the Zeiss Cirrus OCT.Retinal thickness will be measured on the macular cube slab centered on the fovea. This will be measured by a central reader (PI).
Time frame: 1 year and 2 years
Percent Change in Choroidal Thickness in Each Eye From Best State Achieved Prior to week 6 to the Final/Early Termination Visit
Choroidal thickness will be measured using the EDI mode of the Zeiss Cirrus OCT (HD 5 lines raster) and will be measured by a central reader (PI).
Time frame: 1 year and 2 years
Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Baseline to the Final/Early Termination Visit
The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning
Time frame: 1 year and 2 years
Change in scoring of Dual Fluorescein and ICG (Indocyanine Green) angiography from best state achieved
Change in scoring of Dual Fluorescein and ICG (Indocyanine Green) angiography from best state achieved, as defined by the Angiography Scoring for Uveitis Working group using the Heidelberg Scanning LASER fluorescein and ICG angiography
Time frame: 1 year and 2 years
Change in Full Field ElectroRetinoGraphy (ERG) using the ISCEV standard protocols from baseline until the Final Visit
Quantitative values, such as 30 Hz implicit time, amplitude in a and b wave and latency will be recorded
Time frame: 1 year and 2 years