Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT02706704

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

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

32

Participants Needed

1

Research Sites

521 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject is 18 years of age or older.
  • Diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
  • Active disease at baseline with at least one of the following despite 2 weeks of prednisone 10 mg/day or equivalent: active inflammatory lesions, 1+ or more anterior chamber cells, or 1+ or more vitreous haze.
  • Documented prior adequate response to oral corticosteroids up to 1 mg/kg/day prednisone equivalent.
  • Prednisone dose has been stable (no increase or decrease) for at least 14 days if on 10 mg or more.
  • No increase in immune modulatory therapy in the past 3 months.
  • Negative PPD test or positive PPD if on anti-tuberculosis medication.
Not Eligible

You will not qualify if you...

  • Isolated anterior uveitis.
  • Confirmed or suspected infectious uveitis including TB, cytomegalovirus, Lyme disease, toxoplasmosis, or herpes simplex virus.
  • Serpiginous choroidopathy.
  • Corneal or lens opacity that prevents fundus visualization or likely requires cataract surgery during the study.
  • Corneal or lens opacities that prevent evaluation of vitreous haze.
  • Uncontrolled high intraocular pressure (≥ 25 mmHg) despite maximal therapy.
  • Intermediate uveitis with symptoms or MRI findings of demyelinating disease such as multiple sclerosis.
  • Received glucocorticosteroid implants or Ozurdex within 6 months prior to baseline.
  • Received intraocular, periocular corticosteroids, or intravitreal methotrexate within 90 days prior to baseline.
  • Proliferative or severe non-proliferative diabetic retinopathy.
  • Neovascular/wet age-related macular degeneration.
  • Vitreo-retinal interface abnormalities with potential macular damage unrelated to inflammation.
  • Systemic inflammatory disease requiring systemic immunosuppressive therapy at study entry.
  • History of active or latent tuberculosis documented by PPD and chest X-ray without anti-TB treatment.

AI-Screening

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Trial Site Locations

Total: 1 location

1

American University of Beirut Medical Center

Beirut, Lebanon

Actively Recruiting

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Research Team

R

Rola N Hamam, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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