Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms