Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

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

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.

Study Overview

• Status: Completed
• Conditions: Panuveitis; Uveitis; Posterior Uveitis
• Intervention / Treatment: Drug: AEB071

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California Doheny Eye Institute
    • San Francisco, California, United States, 94143
      • University of California
  • Colorado
    • Denver, Colorado, United States, 80230
      • Colorado Retina Associates
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
    • Tampa, Florida, United States, 33612
      • University of South Florida, Eye Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Hospital/Wilmer Eye Institute
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • MERSI
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Department of Opthalmology
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Cornea and Laser Eye Institute
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary, Clinical Research Department
  • Texas
    • Austin, Texas, United States, 78705
      • Retina Research Centre
    • Houston, Texas, United States, 77030
      • Vitreoretinal Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AEB071

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of AEB071	Baseline/Day 1 to Week 8 (Day 56) (end of study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the degree of inflammation in the study eye	Baseline/Day 1, Week 8 (Day 56)/end of study
Change in the visual acuity of the study eye	Baseline/Day 1, Week 8 (Day 56)/end of study
Change in macular edema in the study eye	Baseline/Day 1, Week 8 (Day 56)/end of study

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

Helpful Links

• Results for CAEB071A2211 from the Novartis Clinical Trials website.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Uveitis; Macular Edema
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Uveitis, Posterior; Panuveitis
• Other Study ID Numbers: CAEB071A2211