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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02706704
Study type Interventional
Source American University of Beirut Medical Center
Contact Rola N Hamam, MD
Phone +961-1-350000
Email rh46@aub.edu.lb
Status Recruiting
Phase Phase 2
Start date February 2016
Completion date February 2026

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