Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis (NCT02706704) | Clinical Trial Compass
RecruitingPhase 2
Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
Lebanon32 participantsStarted 2016-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 o…
What they're measuring
1
Vitreous Haze
Timeframe: 26 Weeks
2
Anterior Chamber Cells
Timeframe: 26 Weeks
Trial details
NCT IDNCT02706704
SponsorAmerican University of Beirut Medical Center