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

May 13, 2021 updated by: Clearside Biomedical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Kolkata, India, 700120
        • Disha Eye Hospitals Pvt. Ltd.
      • New Delhi, India, 110029
        • Dr Rajendra Prasad Centre for Ophthalmic Sciences
    • Assam
      • Guwahati, Assam, India, 781028
        • Sri Sankaradeva Nethralaya
    • Karnataka
      • Mysore, Karnataka, India, 570 004
        • JSS Hospital
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641035
        • Sankara Eye Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George's Medical University
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
    • California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Valley Eye Physicians and Surgeons, PC
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Bergstrom Eye Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Casey Eye Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Eye Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include approximately 30 adult subjects that successfully complete the Parent study without requiring additional therapy to treat symptoms for uveitis as defined by the protocol.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Triamcinolone Acetonide
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.
Drug: Sham procedure
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
Other Names:
  • suprachoroidal sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Additional Therapy for Uveitis
Time Frame: 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).
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
Time Frame: 6 months following exit from Parent study
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
Time Frame: 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.
6 months following exit from Parent study
Mean Change From Baseline in Best Corrected Visual Acuity
Time Frame: 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.
6 months following exit from Parent study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clearside Biomedical, Inc.

Investigators

  • Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2017

Primary Completion (Actual)

May 22, 2018

Study Completion (Actual)

May 22, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS1001-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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