RecruitingPhase 2NCT02706704

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

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

Sponsor

American University of Beirut Medical Center

Enrollment

32 participants

Start Date

Feb 1, 2016

Study Type

INTERVENTIONAL

Conditions

Uveitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria14

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.

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Interventions

DRUGAdalimumab

Locations(1)

American University of Beirut Medical Center

Beirut, Lebanon

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NCT02706704

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