MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301

Clearside Biomedical

Status: Completed

Conditions: Uveitis, Anterior; Uveitis; Uveitis, Intermediate; Uveitis, Posterior; Panuveitis

Treatments: Drug: 4 mg CLS-TA Suprachoriodal Injection; Drug: Sham procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT02952001

CLS1001-303

Details and patient eligibility

About

This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). 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.

Full description

This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). 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 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).

This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 2 patient groups

4 mg CLS-TA Suprachoriodal Injection

Description:

Those subjects randomized to the CLS-TA 4 mg arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.

Treatment:

Drug: 4 mg CLS-TA Suprachoriodal Injection

Sham procedure

Description:

Those subjects randomized to the sham procedure arm in CLS1001-301 (NCT02595398) and who completed participation without receiving additional therapy. No study drug was administered during this study.

Treatment:

Drug: Sham procedure