Comparing two methods of administering adalimumab for non-infectious uveitis
Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
This study tests whether giving adalimumab through eye injections or under the skin works better for people with active non-infectious uveitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Drugs / interventions | methotrexate, prednisone, adalimumab |
| Locations | 1 site (Beirut) |
| Trial ID | NCT02706704 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different administration routes of adalimumab in patients with active non-infectious uveitis. Participants will be randomly assigned to receive either intravitreal injections or subcutaneous injections of adalimumab. The study will involve a total of 32 subjects, with follow-up assessments occurring frequently over a 26-week period to monitor changes in ocular inflammation and visual acuity. Comprehensive eye exams and other health assessments will be conducted to ensure participant safety and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with active non-infectious intermediate-, posterior-, or pan-uveitis.
Not a fit: Patients with non-active uveitis or those who have not responded adequately to prior corticosteroid treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from non-infectious uveitis.
How similar studies have performed: Other studies have shown promising results with similar approaches to administering adalimumab, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beirut
- American University of Beirut Medical Center — Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Rola N Hamam, MD — American University of Beirut Medical Center
- Study coordinator: Rola N Hamam, MD
- Email: rh46@aub.edu.lb
- Phone: +961-1-350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.