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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00615693

Enrollment

Registered

2008-02-14

Start date

2008-07-31

Completion date

Unknown

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis, Posterior Uveitis, Panuveitis

Keywords

Uveitis, Macular Edema

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.

Interventions

DRUGAEB071

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026