Efficacy and Safety of Adalimumab in Subjects With Active Uveitis (VISUAL l)
- Conditions
- Active Non-infectious Intermediate, Posterior-, or Pan-uveitis
- Registration Number
- JPRN-jRCT2080221170
- Lead Sponsor
- AbbVie GK (former Abbott Japan Co., Ltd.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 250
Subject is diagnosed with non-infectious intermediate-, posterior-, or pan uveitis.
- 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 despite at least 2 weeks of maintenance therapy with oral prednisone at a dose of 10 mg/day to 60 mg/day (or oral corticosteroid equivalent):
--- Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
--- >/= 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
--- >/= 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
- Subject is on oral prednisone at a dose of 10 mg/day to 60 mg/day (or oral corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from Screening to Baseline visit.
- Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
- Subjects who do not have previous, active or latent TB. Only one TB test is required to allow the subject in the study. Subjects with either negative PPD (< 5 mm of induration) or negative QuantiFERON-TB Gold test (or 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.
- Subject with isolated anterior uveitis.
- Subject with prior inadequate response to high-dose oral corticosteroids.
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Lyme disease, toxoplasmosis, Human T Lymphotropic Virus Type 1 (HTLV-1) infection, Whipple's disease, herpes zoster virus (HZV), and herpes simplex virus (HSV).
- Subject with serpiginous choroidopathy.
- 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 (ETDRS [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 a brain MRI within 90 days prior to the Baseline visit.
- Subject has previous exposure to anti-TNF therapy or any biologic therapy (except intravitreal anti VEGF therapy) with a potential therapeutic impact on non-infectious uveitis.
- If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit or is not within the following allowable doses at the Baseline visit:
--- Methotrexate (MTX) --- Cyclosporine --- Mycophenolate mofetil --- Azathioprine --- Tacrolimus (oral formulation) - Subject has received Retisert (glucocorticosteroids implant) within 3 years prior to the Baseline visit or that has had complications related to the device. Subject has had Retisert (glucocorticosteroid 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 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 MTX within 90 days 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 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method