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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952001
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : May 7, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis Drug: 4 mg CLS-TA Suprachoriodal Injection Drug: Sham procedure

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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018


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 Name: 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 Name: suprachoroidal sham




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952001


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

Documents provided by Clearside Biomedical, Inc.:
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Responsible Party: Clearside Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02952001    
Other Study ID Numbers: CLS1001-303
First Posted: November 1, 2016    Key Record Dates
Results First Posted: May 7, 2021
Last Update Posted: June 2, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clearside Biomedical, Inc.:
Uveitis
UME
Posterior Uveitis
Anterior Uveitis
Intermediate Uveitis
Panuveitis
Non-infectious Uveitis
Triamcinolone
Choroid
Choroidal Injection
Suprachoroidal
Microneedle
Microinjection
Triamcinolone acetonide
Additional relevant MeSH terms:
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Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action