Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Launched by AMERICAN UNIVERSITY OF BEIRUT MEDICAL CENTER · Mar 8, 2016

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to give a medication called adalimumab to people with non-infectious uveitis, which is an eye condition that causes inflammation. The researchers want to see if receiving the medication through an injection into the eye (intravitreal) is more effective than getting it as a shot under the skin (subcutaneous). Both methods aim to help reduce inflammation and improve vision in patients who have active forms of this condition.

To participate in the trial, you must be at least 18 years old and have been diagnosed with non-infectious intermediate, posterior, or pan-uveitis that is currently active. This means you should have specific signs of inflammation in your eyes despite being treated with other medications. The trial is currently recruiting participants, and anyone who meets the criteria will receive either form of adalimumab for treatment. During the trial, participants can expect regular check-ups to monitor their eye health and the effectiveness of the treatment. If you have questions or think you might qualify, it’s a good idea to talk to your doctor for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is ≥ 18 years of age.
• • Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
• * Subject must have active disease at baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone ≥ 10 mg/day (or oral corticosteroid equivalent):
• • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
• • ≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria)
• • ≥ 1+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria)
• • Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
• • If subject is on prednisone \>=10 mg (or corticosteroid equivalent) at baseline, the dose has not been increased or decreased in the past 14 days.
• • No increase in the immune modulatory therapy in the past three months
• • Negative PPD test.
• • Positive PPD test on anti Tb medications.
• Exclusion Criteria:
• • Subject with isolated anterior uveitis.
• • Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, lyme disease, toxoplasmosis and herpes simplex virus (HSV).
• • Subject with serpiginous choroidopathy.
• • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
• • Subject with corneal or lens opacities that preclude the evaluation of the vitreous haze.
• • Subject with uncontrolled high intraocular pressure of ≥ 25 mmHg on maximal therapy.
• • Subject with intermediate uveitis and symptoms and/or MRI findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis must have had a prior brain MRI at time of or after diagnosis of intermediate uveitis.
• • Subject has received glucocorticosteroids implant (Retisert®), or Ozurdex within 6 months prior to baseline visit.
• • Subject has received intraocular or periocular corticosteroids or intravitreal methotrexate within 90 days prior to Baseline visit.
• • Subject with proliferative or severe non-proliferative diabetic retinopathy.
• • Subject with neovascular/wet age-related macular degeneration
• • Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.
• • Subject with a systemic inflammatory disease and requires additional therapy with a systemic immunosuppressive agent at the time of study entry.
• • Subjects with history of active or latent Mycobacterium tuberculosis documented by Purified Protein Derivative (PPD) and chest X-ray and not anti tuberculosis (TB) treatment.