Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Status: | Completed |
---|---|
Conditions: | Cervical Cancer, Cervical Cancer, Ocular, Ocular |
Therapuetic Areas: | Oncology, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | December 8, 2017 |
End Date: | May 22, 2018 |
Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
The purpose of this study is to characterize the continued clinical benefit(s) regarding
safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide
injectable suspension, for the treatment of macular edema associated with non-infectious
uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.
safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide
injectable suspension, for the treatment of macular edema associated with non-infectious
uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.
This is a non-interventional extension study of up to 6 months for subjects completing the
Parent study. The Parent study is a Phase 3, multicenter study to assess the safety and
efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham
procedure in the treatment of subjects with macular edema associated with non-infectious
uveitis.
The study design of the Extension study includes 4 clinic visits over a maximum of 24 weeks.
Subject eligibility will be established at Visit 1 during the crossover day from the Parent
study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to
24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks
following study entry (48 weeks from Parent study randomization).
Parent study. The Parent study is a Phase 3, multicenter study to assess the safety and
efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham
procedure in the treatment of subjects with macular edema associated with non-infectious
uveitis.
The study design of the Extension study includes 4 clinic visits over a maximum of 24 weeks.
Subject eligibility will be established at Visit 1 during the crossover day from the Parent
study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to
24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks
following study entry (48 weeks from Parent study randomization).
Inclusion Criteria:
- Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
- Willing and able to provide written informed consent prior to any study procedures;
willing to comply with the instructions and attend all scheduled study visits
Exclusion Criteria:
- Received additional therapy for the treatment of uveitis or prohibited medication
- Require additional therapy for the treatment of uveitis or prohibited medication at
the time of the Crossover visit
We found this trial at
11
sites
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2485 Hospital Drive
Mountain View, California 94040
Mountain View, California 94040
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3616 Forbes Avenue
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
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