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

Primary Purpose

Uveitis, Posterior Uveitis, Panuveitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AEB071
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Macular Edema

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

  • University of Southern California Doheny Eye Institute
  • University of California
  • Colorado Retina Associates
  • University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
  • University of South Florida, Eye Institute
  • Emory University
  • John Hopkins Hospital/Wilmer Eye Institute
  • MERSI
  • Mayo Clinic Department of Opthalmology
  • Cornea and Laser Eye Institute
  • New York Eye and Ear Infirmary, Clinical Research Department
  • Retina Research Centre
  • Vitreoretinal Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of AEB071

Secondary Outcome Measures

Change in the degree of inflammation in the study eye
Change in the visual acuity of the study eye
Change in macular edema in the study eye

Full Information

First Posted
February 1, 2008
Last Updated
December 15, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00615693
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Posterior Uveitis, Panuveitis
Keywords
Uveitis, Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AEB071
Primary Outcome Measure Information:
Title
Safety and tolerability of AEB071
Time Frame
Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary Outcome Measure Information:
Title
Change in the degree of inflammation in the study eye
Time Frame
Baseline/Day 1, Week 8 (Day 56)/end of study
Title
Change in the visual acuity of the study eye
Time Frame
Baseline/Day 1, Week 8 (Day 56)/end of study
Title
Change in macular edema in the study eye
Time Frame
Baseline/Day 1, Week 8 (Day 56)/end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California Doheny Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Colorado Retina Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida, Eye Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John Hopkins Hospital/Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
MERSI
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Mayo Clinic Department of Opthalmology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cornea and Laser Eye Institute
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New York Eye and Ear Infirmary, Clinical Research Department
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Retina Research Centre
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3540
Description
Results for CAEB071A2211 from the Novartis Clinical Trials website.

Learn more about this trial

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

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