Abatacept, an immunosuppressive drug, known in rheumatology, will be tested in patients with Birdshot uveitis, which is a chronic auto-immune mediated disorder, affecting both eyes. If left untreated the disease can lead to dibilitating visual loss. In this trial the efficacy and safety of the drug will be tested
- Conditions
- Birdshot UveitisHLA A29 retinochoroiditisMedDRA version: 20.0Level: PTClassification code 10072959Term: Birdshot chorioretinopathySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2018-003653-16-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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) (< 5 mm of
induration) or negative QuantiFERON®-TB Gold test (or interferon-
gamma release assay (IGRA) equivalent) are eligible. Subjects with a
repeat indeterminate QuantiFERON®-TB Gold test (or IGRA equivalent)
result are not eligible. Note, that only one TB screening test is allowed
and required. A repeat QuantiFERON® TB Gold test (or IGRA equivalent)
is not permitted if the PPD skin test is positive. The TB screening tests
are diagnostic tests. In the event of a negative TB screening test, the
results are to be interpreted in the context of the patient's epidemiology,
history, exam findings, etc. and it is the responsibility of the investigator
to determine if a patient has previous, active or latent tuberculosis or
not. Under no circumstances can a patient with a positive PPD result or
positive QuantiFERON®-TB Gold test (or IGRA equivalent) enter the
study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
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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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method