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OpenTrials
Completed

NCT Number: NCT00615693

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southern California Doheny Eye Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Serpiginous choroidopathy
  • Acute multifocal placoid pigment epitheliopathy
  • 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

Treatment and study plan

AEB071

Drug

Primary outcomes

  1. Safety and tolerability of AEB071

    Time frame: Baseline/Day 1 to Week 8 (Day 56) (end of study)

Secondary outcomes

  1. Change in the degree of inflammation in the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

  2. Change in the visual acuity of the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

  3. Change in macular edema in the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
First posted
Feb 14, 2008
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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