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Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
American University of Beirut Medical Center
Beirut, Lebanon
Start Date
February 1, 2016
Primary Completion Date
December 1, 2025
Completion Date
February 1, 2026
Last Updated
February 26, 2025
32
ESTIMATED participants
Adalimumab
DRUG
Lead Sponsor
American University of Beirut Medical Center
NCT07218770
NCT05486468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06431373