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Compares treatment options for Uveitis
Official title Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
ClinicalTrials.gov ID: NCT02706704
What this study is testing
What is Adalimumab?
Adalimumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for uveitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- ≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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 people with intermediate uveitis must have had a prior brain MRI at time of or...
- 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.
- people with history of active or latent Mycobacterium tuberculosis documented by Purified Protein Derivative (PPD) and chest X-ray and not anti tuberculosis (TB) treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Beirut, Lebanon
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beirut, Lebanon. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.