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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Clearside Biomedical, Inc.
Study ID
NCT05891548
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLS-AX — DRUG
    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 — DRUG
    Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Jul 2025
Primary completion
Aug 20, 2024
Completion
Aug 20, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.0 mg CLS-AX
    Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
  • Active Comparator: Aflibercept
    Intravitreal injection of aflibercept (2 mg in 0.05 mL)

Primary Outcome Measure

Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time [ Time Frame: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36 ]

Locations (32)

FacilityCityStateZIPSite coordinators
Associated Retina ConsultantsPhoenixArizona85020-
Retinal Research Institute, LLCPhoenixArizona85053-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Northern California Retina Vitreous Associates Medical Group, IncMountain ViewCalifornia94040-
Retina Consultants San DiegoPowayCalifornia92064-
Retinal Consultants of Southern CaliforniaRedlandsCalifornia92374-
Retinal Consultants Medical Group, Inc.SacramentoCalifornia95825-
Retina Group of FloridaFort LauderdaleFlorida33308-
Florida Retina ConsultantsLakelandFlorida33805-
Retina Specialty InstitutePensacolaFlorida32503-
Retina Associates of FloridaTampaFlorida33609-
Southeast Retina CenterAugustaGeorgia30909-
Georgia Retina, PCMariettaGeorgia30060-
Illinois Retina AssociatesOak ParkIllinois60304-
Wolfe Eye ClinicDes MoinesIowa50266-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Vitreo-Retinal Associates, PCWorcesterMassachusetts01605-
Sierra Eye AssociatesRenoNevada89431-
Envision Ocular LLCBloomfieldNew Jersey07003-
Western Carolina Retinal Associates P.A.AshevilleNorth Carolina28803-
Tennessee Retina PCNashvilleTennessee37203-
Retina Research Institute of TexasAbileneTexas79606-
Texas Retina Associates - ArlingtonArlingtonTexas76012-
Austin RetinaAustinTexas78705-
Retina Consultants of Texas-BellairreBellaireTexas77401-
Texas Retina Associates - DallasDallasTexas75231-
Retina Consultants of Texas - KatyKatyTexas77494-
Texas Retina Associates-PlanoPlanoTexas75075-
Retina Consultants of Texas-San AntonioSan AntonioTexas78240-
Retina Group of WashingtonFairfaxVirginia22031-
Spokane Eye Clinical ResearchSpokaneWashington99204-

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By research site
Associated Retina Consultants· Phoenix, AZRetinal Research Institute, LLC· Phoenix, AZCalifornia Retina Consultants· Bakersfield, CARetina Consultants of Orange County· Fullerton, CANorthern California Retina Vitreous Associates Medical Group, Inc· Mountain View, CARetina Consultants San Diego· Poway, CA

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