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

NCT02952001 | Completed Results FDA Drug

• 1 other identifier: CLS1001-303
• Study Type: observational
• Target: 33
• Locations: 2 countries
• Sites: 16

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.

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Keywords

Uveitis; UME; Posterior Uveitis; Anterior Uveitis; Intermediate Uveitis; Panuveitis; Non-infectious Uveitis; Triamcinolone; Choroid; Choroidal Injection; Suprachoroidal; Microneedle; Microinjection; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

  6 months following exit from Parent study

• Mean Change From Baseline in Central Subfield Thickness

  6 months following exit from Parent study

• Mean Change From Baseline in Best Corrected Visual Acuity

  6 months following exit from Parent study

Study Arms (2)

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

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

Interventions

4 mg CLS-TA Suprachoriodal Injection DRUG

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

Also known as: Triamcinolone Acetonide

4 mg CLS-TA Suprachoriodal Injection

Sham procedure DRUG

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

Also known as: suprachoroidal sham

Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (16)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Valley Eye Physicians and Surgeons, PC

Ayer, Massachusetts, 01432, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

Oregon Health & Science University Casey Eye Institute

Portland, Oregon, 97239, United States

Location

University of Pittsburgh Medical Center Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Sri Sankaradeva Nethralaya

Guwahati, Assam, 781028, India

Location

JSS Hospital

Mysore, Karnataka, 570 004, India

Location

Sankara Eye Hospital

Coimbatore, Tamil Nadu, 641035, India

Location

King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Disha Eye Hospitals Pvt. Ltd.

Kolkata, 700120, India

Location

Dr Rajendra Prasad Centre for Ophthalmic Sciences

New Delhi, 110029, India

Location

Related Publications (1)

• 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.

  PMID: 36787524 DERIVED

MeSH Terms

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Subjects enrolled into the Parent study CLS1001-301 (NCT02595398), and who completed the Parent study without receiving additional therapy for uveitis were eligible for enrollment into this non-interventional observation extension study. The Parent study was still masked when subjects enrolled into this extension study, therefore, treatment assignment was unknown at study entry and remained masked until completion of the Parent study which occurred prior to the completion of this study.

Results Point of Contact

• Title: Thomas Ciulla, MD MBA
• Organization: Clearside Biomedical, Inc.

thomas.ciulla@clearsidebio.com

(678) 392-2318

Study Officials

• Thomas Ciulla, MD

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 1, 2016
• Study Start: December 13, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: June 2, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-05

Locations

IN (6); US (10)