What is adalimumab studying for non-infectious uveitis?

Adalimumab is being studied to compare two ways of giving the medication—into the eye or by injection under the skin—to see which better controls inflammation in non-infectious uveitis. This research at the American University of Beirut Medical Center aims to improve treatment options for this eye condition.

Who may be eligible for this non-infectious uveitis clinical trial?

Adults 18 years or older diagnosed with active non-infectious intermediate-, posterior-, or pan-uveitis may be eligible. Both men and women can join if they meet criteria like having recent corticosteroid treatment and negative or treated tuberculosis tests. Please review eligibility criteria for more details.

Is there any cost to participate in this non-infectious uveitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID02706704

Comparing Eye Injection Versus Subcutaneous Injection of Adalimumab for Treating Active Non-Infectious Uveitis

Led by American University of Beirut Medical Center · Updated on 2025-02-26

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of two ways of giving adalimumab, a medication, to people with active non-infectious intermediate-, posterior-, or pan-uveitis, which is inflammation inside the eye. The study will enroll 32 adult participants who have active disease despite recent corticosteroid treatment. It is designed as a Phase 2 trial to evaluate which method better controls inflammation in these types of uveitis. Participants will be randomly assigned to receive either 1.5 mg of adalimumab through intravitreal injection into the eye at the start, 2 weeks, and then every 4 weeks, or 40 mg of adalimumab by subcutaneous injection every 2 weeks. Before starting, participants will have detailed eye exams, blood tests, and imaging scans. Follow-up visits occur frequently initially, then every 4 weeks over a total period of 26 weeks, during which injections may be repeated or delayed depending on disease status and infections. Throughout the study, participants will undergo eye exams including visual acuity tests, retinal imaging, and electroretinography to monitor inflammation and eye health. Blood tests will be done at baseline, mid-study, and at 26 weeks to check safety. Researchers will assess outcomes such as vitreous haze and anterior chamber cell levels at 26 weeks, along with secondary measures including visual acuity, macular edema, angiography scores, and steroid use. Safety monitoring includes close follow-up and removal from the study if vision worsens or inflammation increases significantly.

CONDITIONS

Brief Title

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Subject is 18 years of age or older.
Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
Has active disease at baseline with at least one of the following despite at least 2 weeks of prednisone ≥10 mg/day or equivalent: active chorioretinal or retinal vascular lesion, ≥1+ anterior chamber cells, or ≥1+ vitreous haze.
Documented prior adequate response to oral corticosteroids up to 1 mg/kg/day.
If on prednisone ≥10 mg at baseline, dose stable for past 14 days.
No increase in immune modulatory therapy in past 3 months.
Negative PPD test or positive PPD on anti-tuberculosis medications.

You will not qualify if you...

Has isolated anterior uveitis.
Has confirmed or suspected infectious uveitis including tuberculosis, cytomegalovirus, Lyme disease, toxoplasmosis, or herpes simplex virus.
Has serpiginous choroidopathy.
Has corneal or lens opacity blocking fundus view or likely needing cataract surgery during trial.
Has uncontrolled high intraocular pressure ≥25 mmHg despite maximum therapy.
Has intermediate uveitis with symptoms or MRI findings suggestive of demyelinating disease.
Has received glucocorticosteroid implants within 6 months or intraocular/periocular corticosteroids or intravitreal methotrexate within 90 days before baseline.
Has proliferative or severe non-proliferative diabetic retinopathy.
Has neovascular or wet age-related macular degeneration.
Has vitreo-retinal interface abnormalities that may cause macular damage independent of inflammation.
Has systemic inflammatory disease requiring systemic immunosuppressive therapy at study entry.
Has active or latent tuberculosis not treated with anti-tuberculosis therapy.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 26 weeks

Participants receive adalimumab either by intravitreal injection or subcutaneous injection according to their assigned group. Intravitreal injections are given at baseline, 2 weeks, and then every 4 weeks. Subcutaneous injections are given every 2 weeks.

Multiple visits: every 2 days during the first week, then one week later, followed by visits every 4 weeks

Follow-up

Duration - 26 weeks

Participants are monitored for vision stability and ocular inflammation during follow-up visits. Assessments include ocular coherence tomography and fluorescein angiography at each visit, electroretinography at baseline and 26 weeks, and blood tests at baseline, 14 weeks, and 26 weeks. Treatment may be delayed if acute infection occurs.

Follow-up visits aligned with treatment visits as described