Birdshot Uveitis HLA A29 retinochoroiditis MedDRA version: 20.0 Level: PT Classification code 10072959 Term: Birdshot chorioretinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Orencia
Product Name: Orencia
Product Code: NDC 0003-2187
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current S
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is at least 18 years of age. Subject is diagnosed with Birdshot uveitis, HLA A 29+ Subject must have active disease at the Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye : -Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion -= 1+ vitreous haze (National Eye Institute [NEI]/SUN criteria) Subjects who do not have previous, active or latent tuberculosis (TB). Only one TB test is required to allow the subject in the study. Subjects with either negative purified protein derivative (PPD) (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject with prior inadequate response to high-dose oral corticosteroids (>30 mg of prednisolone or equivalent) Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T- Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV). Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial. Subject with intraocular pressure of = 25 mmHg and on = 2 glaucoma medications or evidence of glaucomatous optic nerve injury. Subject with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study) in at least one eye at the Baseline Visit. Subject with intermediate uveitis or panuveitis that has signs of intermediate uveitis (e.g.presence or history of snowbanking or snowballs) and symptoms and/or magnetic resonance imaging (MRI) findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis or panuveitis that have signs of intermediate uveitis (e.g., presence or history of snowbanking or snowballs) must have had a brain MRI within 90 days prior to the Baseline Visit. Subject has had previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor [VEGF] therapy) with a potential therapeutic impact on non-infectious uveitis Subject with exposure to classic immunosuppressive therapy, in which the dose has been increased within the last 28 days prior to Baseline visit or is within the following doses at the screening visit: Methotrexate (MTX) >25 mg per week Cyclosporine > 4 mg/kg per day Mycophenolate mofetil >2 grams per day or an equivalent drug to mycophenolate mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the Medical Monitor. Azathioprine > 175 mg per day Tacrolimus (oral formulation) >8 mg per day. Subject is still on immunosuppressive therapy ( methotrexate, Cyclosporine, Mycophenolate Mofetil, Azathioprine, Tacrolimus, Sirolimus) at the baseline visit. Subject has received Iluvien® (glucocorticosteroids implant) within 3 years prior to the Baseline visit or that has had complications related to the device. Subject has had Iluvien® (glucocorticosteroids implant) removed within 90 days prior to the Baseline visit or has had complications related to the removal of the device. Subject has received intraocular or periocular corticosteroids within 30 days prior to Baseline visit. Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy. Subject with neovascular/wet age-related macular XML File Identifier: J9CtdmrGsDHeARj9CffpvaNEzI8= Page 11/21 degeneration Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process. Subject with severe vitreous haze that precludes visualization of the fundus at the Baseline visit. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit. Subject has received intravitreal anti- VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the efficacy to suppress active uveitis in Birdshot uveitis and to induce inflammatory remission during the 1 year 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.;Secondary Objective: to test safety of Abatacept in Birdshot uveitis patients to test efficacy of Abatacept in inducing remission in Birdshot uveitis patients to evaluate the visual function in patients taking Abatacept in Birdshot uveitis using both qualitative and quantitative outcome measures to evaluate the utility of new outcome measures (dual scoring of FA/ICG and ERG 30hz implicit time) in detecting disease activity;Primary end point(s): The primary endpoint is 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 best state achieved -30% increase of central retinal thickness on OCT (Optical Coherence Tomography) relative to best state achieved -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).;Timepoint(s) of evaluation of this end point: at each visit week 6, week 12, month 6, month 9, month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit [ Time Frame: From Baseline to Week 6 and 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 XML File Identifier: J9CtdmrGsDHeARj9CffpvaNEzI8= Page 12/21 borders are quite blurry; Grade 4+: Optic nerve head is obscured. -Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit [ Time Frame: From Baseline to Week 6 and 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 to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6 [ Time Frame: From Baseline until the Final Visit ] 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 Week 6 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. -P | — |
Countries
Belgium
Contacts
Public ContactOphthalmology Department
UZ Leuven
Outcome results
None listed