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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis

Intervention / Treatment
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* Drug: 4 mg CLS-TA Suprachoriodal Injection
* Drug: Sham procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4 mg CLS-TA Suprachoriodal Injection<br>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. | Drug: 4 mg CLS-TA Suprachoriodal Injection<br>* This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.<br>* Other names: Triamcinolone Acetonide;|
| Sham procedure<br>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. | Drug: Sham procedure<br>* This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.<br>* Other names: suprachoroidal sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Additional Therapy for Uveitis | 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). | 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study. | 6 months following exit from Parent study | 
| Mean Change From Baseline in Central Subfield Thickness | 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. | 6 months following exit from Parent study | 
| Mean Change From Baseline in Best Corrected Visual Acuity | 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. | 6 months following exit from Parent study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone, Choroid, Choroidal Injection, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide