Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Adalimumab

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.