Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
NCT ID: NCT05891548
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2023-05-31
2024-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1.0 mg CLS-AX
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
CLS-AX
CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria.
Aflibercept
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
Aflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).
Interventions
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CLS-AX
CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria.
Aflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% of the 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 intravitreal injections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) 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 Criteria
* Central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on SD-OCT in the study eye.
* Subretinal hemorrhage, fibrosis or atrophy of \>50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography 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 study eye.
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.
50 Years
ALL
No
Sponsors
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Clearside Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Coultas, PhD
Role: STUDY_DIRECTOR
Clearside Biomedical, Inc.
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Research Institute, LLC
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc
Mountain View, California, United States
Retina Consultants San Diego
Poway, California, United States
Retinal Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Associates of Florida
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina, PC
Marietta, Georgia, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Wolfe Eye Clinic
Des Moines, Iowa, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular LLC
Bloomfield, New Jersey, United States
Western Carolina Retinal Associates P.A.
Asheville, North Carolina, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates - Arlington
Arlington, Texas, United States
Austin Retina
Austin, Texas, United States
Retina Consultants of Texas-Bellairre
Bellaire, Texas, United States
Texas Retina Associates - Dallas
Dallas, Texas, United States
Retina Consultants of Texas - Katy
Katy, Texas, United States
Texas Retina Associates-Plano
Plano, Texas, United States
Retina Consultants of Texas-San Antonio
San Antonio, Texas, United States
Retina Group of Washington
Fairfax, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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CLS1002-202
Identifier Type: -
Identifier Source: org_study_id
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