Clinical Trial: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Treatm
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 Summary:
Sponsor: Novartis
Current Primary Outcome: Safety and tolerability of AEB071 [ Time Frame: Baseline/Day 1 to Week 8 (Day 56) (end of study) ]
Original Primary Outcome: Change in macular edema from baseline to week 8 [ Time Frame: throughout the study ]
Current Secondary Outcome:
- Change in the degree of inflammation in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]
- Change in the visual acuity of the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]
- Change in macular edema in the study eye [ Time Frame: Baseline/Day 1, Week 8 (Day 56)/end of study ]
Original Secondary Outcome:
- Change in haziness of the vitreous (the inside of the eye) from baseline to week 8 [ Time Frame: throughout the study ]
- Mean increase or decrease in visual acuity from baseline to week 8 [ Time Frame: throughout the study ]
- Time required to see a clinically meaningful effect of drug [ Time Frame: throughout the study ]
- If rescue medication is necessary, time required before administration [ Time Frame: throughout the study ]
Information By: Novartis
Dates:
Date Received: February 1, 2008
Date Started: July 2008
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017
