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Neovascular Age-related Macular DegenerationPhase 2ODYSSEYNCT05891548

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

A Phase 2 study testing CLS-AX and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
CLS-AX and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
32 sitesUnited States
Study dates
31 May 2023to 20 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Texas Retina Associates - Arlington

    Arlington, Texas, 76012

  • Western Carolina Retinal Associates P.A.

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Consultants of Texas-Bellairre

    Bellaire, Texas, 77401

  • Envision Ocular LLC

    Bloomfield, New Jersey, 07003

  • Texas Retina Associates - Dallas

    Dallas, Texas, 75231

  • Wolfe Eye Clinic

    Des Moines, Iowa, 50266

  • Retina Group of Washington

    Fairfax, Virginia, 22031

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Retina Consultants of Texas - Katy

    Katy, Texas, 77494

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Georgia Retina, PC

    Marietta, Georgia, 30060

  • Northern California Retina Vitreous Associates Medical Group, Inc

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • Texas Retina Associates-Plano

    Plano, Texas, 75075

  • Retina Consultants San Diego

    Poway, California, 92064

  • Retinal Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89431

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95825

  • Retina Consultants of Texas-San Antonio

    San Antonio, Texas, 78240

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Associates of Florida

    Tampa, Florida, 33609

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
CLS-AX, Aflibercept
Keywords
AMD, Wet AMD, Suprachoroidal, Tyrosine kinase inhibitor, Microinjector, Suprachoroidal Space (SCS)
Medical subject headings
Choroidal Effusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLS-AXDrug

    Also called axitinib injectable suspension

    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.

  • AfliberceptDrug

    Also called Eylea

    Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Study groups in NCT05891548
Study groupRoleWhat they receive
1.0 mg CLS-AXExperimentalSuprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
Receives: Drug: CLS-AX
AfliberceptActive comparatorIntravitreal injection of aflibercept (2 mg in 0.05 mL)
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time

    Best Corrected Visual Acuity (BCVA) letter score measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable). An increase in BCVA letter score from baseline indicates an improvement in visual acuity.

    Measured: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36

Secondary outcomes (4)

  1. Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time

    Spectral-domain optical coherence tomography (SD-OCT) is a non-invasive diagnostic technique that provides high-resolution, cross-sectional tissue imaging and analysis of structural changes in the eye during disease progression. A central reading center will provide measurements and standardized gradings of outcomes related to retinal thickness and fluid in the eye, respectively.

    Central subfield retinal thickness (CST) is defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in millimeters in the circular region centered on the anatomic fovea with a radius of 500 microns.

    The presence and location of intraretinal and subretinal fluid in the central subfield (center 1 mm) is graded as Absent (the best grade attainable); Definite, outside center subfield; Definite, center subfield involved; and Definite, both center subfield and outer subfields involved.

    Measured: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36

  2. Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time

    Fundus fluorescein angiography (FFA) is an invasive diagnostic procedure used to assess the anatomy, physiology, and pathology of retinal and choroidal circulation. It involves injecting fluorescein dye into a vein in the arm/hand and taking pictures as it circulates through the eye. A central reading center will provide measurements of outcomes related to the size of lesions/leakage in the eye.

    Total area of Choroidal Neovascularization (CNV) includes classic and occult components and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.

    Total lesion area includes the total CNV and associated lesion components and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.

    Total area of leakage includes the total area leakage from neovascularization and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.

    Measured: Baseline, Week 36

  3. Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time

    Number of masked study drug injections and supplemental therapy injections administered in the study eye.

    Measured: From Baseline Through Week 36

  4. Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)

    The analysis of serious adverse events (SAEs) includes both ocular and non-ocular (systemic) adverse events (AEs) meeting SAE criteria as defined in International Conference on Harmonisation (ICH) E6 Good Clinical Practice Consolidated Guidance. TEAEs are defined as adverse events that emerge during or after treatment with masked treatment having been absent pre-treatment or worsens relative to the pre-treatment state.

    Investigators will seek information on AEs at each contact with the participant. All AEs are recorded and the Investigator will independently assess seriousness, severity, and causality of each AE.

    Measured: From first dose of masked study drug through the end of the study (up to 36 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start31 May 2023
  3. Primary completion20 Aug 2024
  4. Study completion20 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two treatment groups in parallel for the duration of the study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891548
Sponsor's protocol ID
CLS1002-202
Acronym
ODYSSEY
Status last verified
Jul 2025
First submitted
24 May 2023
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLS-AX and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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