Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
Recruiting
Phase 2Interventional Study
UveitisNon-Infectious Uveitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
American University of Beirut Medical Center · Other
Who this trial is looking for
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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.
Trial Locations
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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 …
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.
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