Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02706704
• Date of registration: 08/03/2016
• Prospective Registration: No
• Primary sponsor: American University of Beirut Medical Center
• Public title: Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis IVAS
• Scientific title: Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
• Date of first enrolment: February 2016
• Target sample size: 32
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02706704
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Lebanon

Contacts

• Name: Rola N Hamam, MD

• Name: Rola N Hamam, MD
• Affiliation: American University of Beirut Medical Center

• Name: Rola N Hamam, MD

Key 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Infectious Uveitis

Uveitis

Intervention(s)

Drug: Adalimumab

Primary Outcome(s)

Vitreous Haze [Time Frame: 26 Weeks]

Anterior Chamber Cells [Time Frame: 26 Weeks]

Secondary Outcome(s)

Visual Acuity [Time Frame: 26 Weeks]

Macular Edema [Time Frame: 26 Weeks]

Steroids Tapering [Time Frame: 26 Weeks]

Angiography Score [Time Frame: 26 Weeks]

Secondary ID(s)

OPH.RH.07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors