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

Phase 2

Completed

• Conditions: Posterior Uveitis; Uveitis; Panuveitis
• Interventions: Drug: AEB071

• Registration Number: NCT00615693
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Study Start: 2008-07
• Primary Completion: 2009-10
• Status Verified: 2017-02
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AEB071	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AEB071	Baseline/Day 1 to Week 8 (Day 56) (end of study)

Secondary Outcome Measures

Name	Time	Method
Change in macular edema in the study eye	Baseline/Day 1, Week 8 (Day 56)/end of study
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

Trial Locations

Locations (13)

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

John Hopkins Hospital/Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States

University of California; 🇺🇸 San Francisco, California, United States

University of South Florida, Eye Institute; 🇺🇸 Tampa, Florida, United States

New York Eye and Ear Infirmary, Clinical Research Department; 🇺🇸 New York, New York, United States

University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

MERSI; 🇺🇸 Cambridge, Massachusetts, United States

Cornea and Laser Eye Institute; 🇺🇸 Teaneck, New Jersey, United States

Colorado Retina Associates; 🇺🇸 Denver, Colorado, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Mayo Clinic Department of Opthalmology; 🇺🇸 Rochester, Minnesota, United States

Retina Research Centre; 🇺🇸 Austin, Texas, United States

Vitreoretinal Consultants; 🇺🇸 Houston, Texas, United States