Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration

Last updated: January 8, 2025
Sponsor: Clearside Biomedical, Inc.
Overall Status: Completed

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

CLS-AX

Aflibercept

Clinical Study ID

NCT05891548
CLS1002-202
  • Ages > 50
  • All Genders

Study Summary

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eyewithin 36 months of Visit 1.

  • Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type inthe study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% ofthe total lesion area, and and CNV must not be associated with subfoveal hemorrhage,subfoveal fibrosis, or subfoveal atrophy.

  • Previous treatment in the study eye with between 2 and 4 anti-VEGF intravitrealinjections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, oraflibercept) per standard of care within 6 months of Visit 1.

  • History of response to prior intravitreal anti-VEGF treatment in the study eye.

  • ETDRS BCVA of between 20 and 80 letters (inclusive) in the study eye.

Exclusion

Key Exclusion Criteria:

  • ETDRS BCVA <20 letters in the study eye.

  • Central subfield thickness > 400 μm or retinal pigment epithelium detachmentthickness >400 μm on SD-OCT in the study eye.

  • Subretinal hemorrhage, fibrosis or atrophy of >50% of the total lesion area and/orthat involves the fovea on fundus fluorescein angiography and/or color fundusphotography in the study eye.

  • CNV due to causes other than AMD, such are ocular histoplasmosis, trauma,pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the studyeye.

  • Any history of macular pathology unrelated to AMD affecting vision or contributingto the presence of intraretinal or subretinal fluid in the study eye.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: CLS-AX
Phase: 2
Study Start date:
May 31, 2023
Estimated Completion Date:
August 20, 2024

Study Description

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-VEGF standard of care therapy. Active-control will be 2 mg intravitreal injections of aflibercept dosed per the EYLEA Prescribing Information. Only one eye will be chosen as the study eye.

Connect with a study center

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Retinal Research Institute, LLC

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates Medical Group, Inc

    Mountain View, California 94040
    United States

    Site Not Available

  • Retina Consultants San Diego

    Poway, California 92064
    United States

    Site Not Available

  • Retinal Consultants of Southern California

    Redlands, California 92374
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California 95825
    United States

    Site Not Available

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Retina Associates of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Georgia Retina, PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Wolfe Eye Clinic

    Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89431
    United States

    Site Not Available

  • Envision Ocular LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Western Carolina Retinal Associates P.A.

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Tennessee Retina PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates - Arlington

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Retina

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Consultants of Texas-Bellairre

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Texas Retina Associates - Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Retina Consultants of Texas - Katy

    Katy, Texas 77494
    United States

    Site Not Available

  • Texas Retina Associates

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Texas Retina Associates-Plano

    Plano, Texas 75075
    United States

    Site Not Available

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas-San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Group of Washington

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

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