NCT02952001

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

MAGNOLIA: 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Uveitis
• Uveitis, Posterior
• Uveitis, Anterior
• Uveitis, Intermediate
• Panuveitis

Interventions

Type	Name	Description
DRUG	4 mg CLS-TA Suprachoriodal Injection	This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
DRUG	Sham procedure	This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Timeline

• Start date: 2017-12-13
• Primary completion: 2018-05-22
• Completion: 2018-05-22
• First posted: 2016-11-01
• Last updated: 2021-06-02
• Results posted: 2021-05-07

Locations

16 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study