The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.
Subject groups: 32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a repeat injection. Follow up will be every 2 days the first week then one week later and after that every 4-week intervals for total of 26 weeks. Intervention Details: * Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks. * Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks. Pre-treatment work up Patients will undergo a comprehensive eye exam: * Visual acuity, slit-lamp examination of the anterior segment, dilated fundus examination, electroretinography (ERG) and fluorescein angiography (FA). * Central macular thickness of all eyes will be measured with ocular coherence tomography before treatment. * Purified Protein Derivative (PPD), Complete blood count (CBC) and SGPT. Post-injection follow-up * Patients will be followed up every 2 days during the first week then one week later and after that every 4-week intervals. * On follow up visits, if deterioration in vision of two or more ETDRS lines or worsening of ocular inflammation by more than 1+ cells/haze is detected at any visit, patients will be removed from the study and receive appropriate treatment. Otherwise, if vision was stable or improved and/or inflammation is same or better, patients will be re-injected. * Follow up is for 26 weeks. * OCT and fluorescein angiography each visit. * ERG will be performed at baseline and 26 weeks. * Blood studies (CBC and SGPT) will be performed at baseline, 14 weeks and at 26 weeks. * Injections would be delayed if a patient has an acute infection and would be given when it subsides.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
American University of Beirut Medical Center
Beirut, Lebanon
RECRUITINGVitreous Haze
Change in Vitreous Haze grade in each eye \[National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria\]
Time frame: 26 Weeks
Anterior Chamber Cells
Change in Anterior Chamber (AC) cell grade in each eye.
Time frame: 26 Weeks
Visual Acuity
Change in ETDRS letters and logarithm of the minimum angle of resolution (log MAR) best-corrected visual acuity (BCVA) in each eye.
Time frame: 26 Weeks
Macular Edema
Change in central retinal thickness on Optical Coherence Tomography (OCT).
Time frame: 26 Weeks
Angiography Score
Change in fluorescein angiography score
Time frame: 26 Weeks
Steroids Tapering
If the patient is initially on steroids (pre-enrolment); Success in tapering steroid dose as a response to the protocol.
Time frame: 26 Weeks
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