Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

Last updated: May 4, 2021
Sponsor: Clearside Biomedical, Inc.
Overall Status: Completed

Phase

3

Condition

Uveitis

Posterior Uveitis

Macular Edema

Treatment

N/A

Clinical Study ID

NCT02595398
CLS1001-301
  • Ages > 18
  • All Genders

Study Summary

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
  • Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
  • Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 lettersread (20/40 Snellen equivalent), in the study eye

Exclusion

Exclusion Criteria:

  • Any active ocular disease or infection in the study eye other than uveitis
  • Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects arenot excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
  • Any uncontrolled systemic disease that, in the opinion of the Investigator, wouldpreclude participation in the study
  • Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular orperiocular corticosteroid injections in the 2 months prior to baseline; an OZURDEXimplant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 yearsprior to baseline.

Study Design

Total Participants: 160
Study Start date:
November 17, 2015
Estimated Completion Date:
January 18, 2018

Study Description

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Connect with a study center

  • L V Prasad Eye Hospital

    Hyderabad, Andhra Pradesh
    India

    Site Not Available

  • Sri Sankaradeva Nethralaya

    Guwahati, Assam
    India

    Site Not Available

  • M&J Western Regional Institute of Ophthalmology

    Ahmedabad, Gujarat
    India

    Site Not Available

  • JSS Hospital

    Mysore, Karnataka
    India

    Site Not Available

  • Regional Institute of Ophthalmology

    Thiruvananthapuram, Kerala
    India

    Site Not Available

  • TN Medical College and BYL Nair Hospital

    Mumbai, Maharashtra
    India

    Site Not Available

  • PBMA's H V Desai Eye Hospital

    Pune, Maharashtra
    India

    Site Not Available

  • Dr Rajendra Prasad Centre for Ophthalmic Sciences

    Ansari Nagar, New Delhi
    India

    Site Not Available

  • Sankara Nethralaya

    Chennai, Tamil Nadu
    India

    Site Not Available

  • Sankara Eye Hospital

    Coimbatore, Tamil Nadu
    India

    Site Not Available

  • King George's Medical University

    Lucknow, Uttar Pradesh
    India

    Site Not Available

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh
    India

    Site Not Available

  • Icare Eye Hospital & PG Institute

    Noida, Uttar Pradesh
    India

    Site Not Available

  • Calcutta Medical Research Institute

    Kolkata, 700027
    India

    Site Not Available

  • Disha Eye Hospital

    Kolkata,
    India

    Site Not Available

  • Dr Rajendra Prasad Centre for Ophthalmic Sciences

    New Delhi, 110029
    India

    Site Not Available

  • Dr. Shroff's Charity Eye Hospital

    New Delhi,
    India

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, 85025
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 3104802
    Israel

    Site Not Available

  • Rambam Health Corp

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah-Hebrew University Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot, 76100
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Retinal Consultants of Arizona

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Retina Centers, PC

    Tucson, Arizona 85704
    United States

    Site Not Available

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • USC Eye Institute

    Los Angeles, California 90033
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates Medical Group, Inc.

    Mountain View, California 94040
    United States

    Site Not Available

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Colorado Retina Associates

    Golden, Colorado 80401
    United States

    Site Not Available

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Retina Group of Florida

    Ft Lauderdale, Florida 33308
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Emory Eye Center Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Marietta Eye Clinic

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Midwest Eye Retina Practicing at Midwest Eye Institute

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Elman Retina Group, PA

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • The Retina Group of Washington

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Valley Eye Physicians and Surgeons, PC

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution

    Waltham, Massachusetts 01741
    United States

    Site Not Available

  • empty

    Detroit, Michigan 48201
    United States

    Site Not Available

  • empty

    Jackson, Mississippi 49202
    United States

    Site Not Available

  • Discover Vision Centers

    Independence, Missouri 64055
    United States

    Site Not Available

  • empty

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Metropolitan Eye Research & Surgery Institute

    Palisades Park, New Jersey 07650
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • Retina Consultants PLLC

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Charlotte Eye Ear Nose and Throat Associates, PA

    Belmont, North Carolina 28012
    United States

    Site Not Available

  • Wake Forest Baptist Health Eye Center

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Wake Forest Baptist Health Eye Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Bergstrom Eye Research

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Oregon Health & Science University Casey Eye Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Eye Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Innovative Clinical Research

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Carolina Macula and Retina

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Carolina Macula and Retina

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Retina Consultants of Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Foresight Studies, LLC

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Retina Consultants of Houston

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Vitreoretinal Associates of Washington

    Bellevue, Washington 98004
    United States

    Site Not Available

  • empty

    Seattle, Washington 98105
    United States

    Site Not Available

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