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NCT05891548CompletedPhase 2

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

ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration

Source: ClinicalTrials.gov · Last updated 25 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
24 May 2023
Start date
31 May 2023
Primary completion date
20 Aug 2024
Lead sponsor
Clearside Biomedical, Inc.
NCT number
NCT05891548

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • From 31 May 2023 to the primary completion date, 20 Aug 2024
  • 32 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • ETDRS BCVA \<20 letters in the study eye.
  • Central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on SD-OCT 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.

Who the study is looking for

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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Retina Research Institute of Texas
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AbileneUnited StatesUnknown status
Texas Retina Associates - Arlington
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ArlingtonUnited StatesUnknown status
Western Carolina Retinal Associates P.A.
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AshevilleUnited StatesUnknown status
Southeast Retina Center
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AugustaUnited StatesUnknown status
Austin Retina
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AustinUnited StatesUnknown status
California Retina Consultants
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BakersfieldUnited StatesUnknown status
Retina Consultants of Texas-Bellairre
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BellaireUnited StatesUnknown status
Envision Ocular, LLC
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BloomfieldUnited StatesUnknown status
Texas Retina Associates - Dallas
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DallasUnited StatesUnknown status
Wolfe Eye Clinic
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Des MoinesUnited StatesUnknown status
Retina Group of Washington
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FairfaxUnited StatesUnknown status
Retina Group of Florida
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Fort LauderdaleUnited StatesUnknown status
Retina Consultants of Orange County
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FullertonUnited StatesUnknown status
Cumberland Valley Retina Consultants
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HagerstownUnited StatesUnknown status
Retina Consultants of Texas - Katy
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KatyUnited StatesUnknown status
Florida Retina Consultants
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LakelandUnited StatesUnknown status
Georgia Retina PC
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MariettaUnited StatesUnknown status
Northern California Retina Vitreous Associates Medical Group INC.
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Mountain ViewUnited StatesUnknown status
Tennessee Retina, PC
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NashvilleUnited StatesUnknown status
Illinois Retina Associates
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Oak ParkUnited StatesUnknown status
Retina Specialty Institute
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PensacolaUnited StatesUnknown status
Retinal Research Institute, LLC
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PhoenixUnited StatesUnknown status
Associated Retina Consultants
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PhoenixUnited StatesUnknown status
Texas Retina Associates (Plano)
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PlanoUnited StatesUnknown status
Retina Consultants San Diego
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PowayUnited StatesUnknown status
Retinal Consultants of Southern California
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RedlandsUnited StatesUnknown status
Sierra Eye Associates
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RenoUnited StatesUnknown status
Retinal Consultants Medical Group, Inc.
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SacramentoUnited StatesUnknown status
Retina Consultants of Texas: San Antonio
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San AntonioUnited StatesUnknown status
Spokane Eye Clinical Research
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SpokaneUnited StatesUnknown status
Retina Associates of Florida
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TampaUnited StatesUnknown status
Vitreo-Retinal Associates, PC
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.