Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

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Brief Title

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

Official Title

Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis

Brief Summary

      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.
    

Detailed Description

      Subject groups:

      32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to
      receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab
      subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a
      repeat injection. Follow up will be every 2 days the first week then one week later and after
      that every 4-week intervals for total of 26 weeks.

      Intervention Details:

        -  Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2
           weeks.

        -  Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2
           weeks, and then every 4 weeks.

      Pre-treatment work up

      Patients will undergo a comprehensive eye exam:

        -  Visual acuity, slit-lamp examination of the anterior segment, dilated fundus
           examination, electroretinography (ERG) and fluorescein angiography (FA).

        -  Central macular thickness of all eyes will be measured with ocular coherence tomography
           before treatment.

        -  Purified Protein Derivative (PPD), Complete blood count (CBC) and SGPT.

      Post-injection follow-up

        -  Patients will be followed up every 2 days during the first week then one week later and
           after that every 4-week intervals.

        -  On follow up visits, if deterioration in vision of two or more ETDRS lines or worsening
           of ocular inflammation by more than 1+ cells/haze is detected at any visit, patients
           will be removed from the study and receive appropriate treatment. Otherwise, if vision
           was stable or improved and/or inflammation is same or better, patients will be
           re-injected.

        -  Follow up is for 26 weeks.

        -  OCT and fluorescein angiography each visit.

        -  ERG will be performed at baseline and 26 weeks.

        -  Blood studies (CBC and SGPT) will be performed at baseline, 14 weeks and at 26 weeks.

        -  Injections would be delayed if a patient has an acute infection and would be given when
           it subsides.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Vitreous Haze

Secondary Outcome

 Visual Acuity

Condition

Uveitis

Intervention

Adalimumab

Study Arms / Comparison Groups

 Intravitreal
Description:  Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

32

Start Date

February 2016

Completion Date

June 2019

Primary Completion Date

December 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rola N Hamam, MD, +961-1-350000, [email protected]

Location Countries

Lebanon

Location Countries

Lebanon

Administrative Informations


NCT ID

NCT02706704

Organization ID

OPH.RH.07


Responsible Party

Sponsor

Study Sponsor

American University of Beirut Medical Center


Study Sponsor

Rola N Hamam, MD, Principal Investigator, American University of Beirut Medical Center


Verification Date

February 2016