NCT02706704

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Uveitis
• Non-Infectious Uveitis

Interventions

Type	Name	Description
DRUG	Adalimumab

Timeline

• Start date: 2016-02-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2016-03-11
• Last updated: 2025-02-26

Locations

1 site across 1 country: Lebanon