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

NCT ID: NCT02952001

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2018-05-22

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

4 mg CLS-TA Suprachoriodal Injection

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.

4 mg CLS-TA Suprachoriodal Injection

Intervention Type: DRUG

This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Sham procedure

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.

Sham procedure

Intervention Type: DRUG

This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Interventions

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.

Intervention Type: DRUG

Sham procedure

This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Intervention Type: DRUG

Other Intervention Names

Triamcinolone Acetonide; suprachoroidal sham

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clearside Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Ciulla, MD

Role: STUDY_DIRECTOR

Clearside Biomedical, Inc.

Locations

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, United States

Retina Group of Florida

Fort Lauderdale, Florida, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Valley Eye Physicians and Surgeons, PC

Ayer, Massachusetts, United States

Bergstrom Eye Research

Fargo, North Dakota, United States

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, United States

University of Pittsburgh Medical Center Eye Center

Pittsburgh, Pennsylvania, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Consultants of Houston

The Woodlands, Texas, United States

Sri Sankaradeva Nethralaya

Guwahati, Assam, India

JSS Hospital

Mysore, Karnataka, India

Sankara Eye Hospital

Coimbatore, Tamil Nadu, India

King George's Medical University

Lucknow, Uttar Pradesh, India

Disha Eye Hospitals Pvt. Ltd.

Kolkata, , India

Dr Rajendra Prasad Centre for Ophthalmic Sciences

New Delhi, , India

Countries

United States; India

References

Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324.

Reference Type: DERIVED

PMID: 36787524 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLS1001-303

Identifier Type: -

Identifier Source: org_study_id