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

Completed

• Conditions: Uveitis; Uveitis, Intermediate; Panuveitis; Uveitis, Anterior; Uveitis, Posterior
• Interventions: Drug: Sham procedure; Drug: 4 mg CLS-TA Suprachoriodal Injection

• Registration Number: NCT02952001
• Lead Sponsor: Clearside Biomedical, Inc.

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.

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-01
• Study Start: 2017-12-13
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Results First Submitted: 2021-04-14
• Results First Submitted QC: 2021-04-14
• Status Verified: 2021-05
• Results First Posted: 2021-05-07
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sham procedure	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.
4 mg CLS-TA Suprachoriodal Injection	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.

Primary Outcome Measures

Name	Time	Method
Time to Additional Therapy for Uveitis	6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year	This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events	6 months following exit from Parent study	Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.
Mean Change From Baseline in Central Subfield Thickness	6 months following exit from Parent study	Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Mean Change From Baseline in Best Corrected Visual Acuity	6 months following exit from Parent study	Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Trial Locations

Locations (16)

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

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