Clinical trial NCT00615693: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Official title: A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis
Posterior Uveitis
Panuveitis
Keywords: Uveitis
Macular Edema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
* Macular edema with average central retinal thickness ≥ 250 µm
* A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
* Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
* Daily prednisone dose \< 1 mg/kg

Exclusion Criteria:

* Patients with choroidal neovascularization.
* Patients with the following forms of uveitis:

  1. Serpiginous choroidopathy
  2. Acute multifocal placoid pigment epitheliopathy
  3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)
* Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
* Patients who had a prior vitrectomy
* Any eye condition that may affect the evaluation of visual acuity and retinal thickness
* Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)
* Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability of AEB071
timeFrame: Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary outcomes:
measure: Change in the degree of inflammation in the study eye
timeFrame: Baseline/Day 1, Week 8 (Day 56)/end of study
measure: Change in the visual acuity of the study eye
timeFrame: Baseline/Day 1, Week 8 (Day 56)/end of study
measure: Change in macular edema in the study eye
timeFrame: Baseline/Day 1, Week 8 (Day 56)/end of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Doheny Eye Institute
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Denver
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Miami
country: United States
facility: University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: John Hopkins Hospital/Wilmer Eye Institute
state: Maryland
city: Cambridge
country: United States
facility: MERSI
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Department of Opthalmology
state: Minnesota
city: Teaneck
country: United States
facility: Cornea and Laser Eye Institute
state: New Jersey
city: New York
country: United States
facility: New York Eye and Ear Infirmary, Clinical Research Department
state: New York
city: Austin
country: United States
facility: Retina Research Centre
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants
state: Texas
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: