Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis — IVAS  

Uveitis Clinical Trial

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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Non-Infectious Uveitis
• Uveitis

• 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