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Neovascular Age-related Macular DegenerationPhase 1/2OASISNCT04626128

Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD

A Phase 1/2 study testing CLS-AX and Anti-VEGF in people with Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 11 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

To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD) Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
CLS-AX and Anti-VEGF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
11 sitesUnited States
Study dates
15 Dec 2020to 13 Oct 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 in the study eye.
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Two or more prior anti-VEGF intravitreal injections
  • EDTRS BCVA score ≤ 75 and ≥ 20 letters

Who cannot join

  • Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD
  • Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
  • IOP ≥ 25mmHg or cup-to-disc ratio >0.8
  • Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
  • Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Northern California Retina Vitreous Associates Medical Group, LLC

    Mountain View, California, 94040

  • Retinal Consultants of Arizona

    Phoenix, Arizona, 85014

  • Retinal Consultants Medical Group

    Sacramento, California, 95825

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration

To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)

Read the detailed description

Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

Being tested
CLS-AX, Anti-VEGF
Keywords
AMD, Wet-AMD, suprachoroidal, tyrosine kinase inhibitor, Microinjector, SCS

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

    injectable suspension of small molecule tyrosine kinase inhibitor (TKI)

  • Anti-VEGFDrug

    Also called aflibercept (2mg)

    Standard of care therapy used to block vascular endothelial growth factor

Study groups in NCT04626128
Study groupRoleWhat they receive
Cohort 1 (Low Dose)ExperimentalSubjects will receive a low dose of 0.03 mg CLS-AX
Receives: Drug: CLS-AX; Drug: Anti-VEGF
Cohort 2 (Low-mid Dose)ExperimentalSubjects will receive a low-mid dose of 0.10 mg CLS-AX
Receives: Drug: CLS-AX; Drug: Anti-VEGF
Cohort 3 (High-mid Dose)ExperimentalSubjects will receive a high-mid dose of 0.50 mg CLS-AX
Receives: Drug: CLS-AX; Drug: Anti-VEGF
Cohort 4 (High Dose)ExperimentalSubjects will receive a high-mid dose of 1.0 mg CLS-AX
Receives: Drug: CLS-AX; Drug: Anti-VEGF

What is being measured

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

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.

    Measured: Day 1 to Week 12

  2. Number of Participants With Serious Adverse Events

    Number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.

    Measured: Day 1 to Week 12

Secondary outcomes (6)

  1. Mean Change From Baseline in Pre Injection Intraocular Pressure (IOP)

    Intraocular pressure (IOP) is a diagnostic measurement of the fluid pressure, measured in millimeters of mercury, inside the eye. IOP was measured using Goldmann applanation tonometry or by use of a Tonopen tonometer. Normal eye pressure is usually considered to be between 10 and 20 mmHg (AAO.org). Untreated elevated eye pressure is a risk factor for glaucoma.

    Measured: Weeks 4, 8 and 12.

  2. Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

    Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD. Participants qualified to receive additional IVT aflibercept injections based on protocol-defined criteria, including 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness >75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye. Additionally, a participant could receive additional IVT aflibercept injections in the study eye for reasons beyond the protocol-defined criteria if it was in the participant's best interest per the Investigator's judgment following best medical practice.

    Measured: From Day 1 to Week 12

  3. Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections

    Number of participants qualifying to receive additional intravitreal aflibercept injections during the course of the study. Criteria included 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness >75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye.

    Measured: Day 1 to Week 12

  4. Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye

    Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A central reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.

    Measured: Weeks 4, 8 and 12

  5. Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye

    BCVA 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), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.

    Measured: Weeks 4, 8 and 12

  6. Maximum Plasma Concentration [Cmax] of Axitinib

    Maximum (or peak) plasma concentration of axitinib during the course of the study. Plasma samples were collected pre-dose at Baseline, 60 minutes post-dose at Baseline, and at Weeks 4 and 12. Peak quantifiable levels, based on a lower level of quantitation (LLOQ) of 0.01 ng/mL, were included in the analysis.

    Measured: Day 1 to Week 12

Timeline

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

  1. First posted12 Nov 2020
  2. Study start15 Dec 2020
  3. Primary completion13 Oct 2022
  4. Study completion13 Oct 2022

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Four groups of approximately 5 participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626128
Sponsor's protocol ID
CLS1002-101
Acronym
OASIS
Status last verified
Aug 2023
First submitted
2 Nov 2020
Last updated
18 Sep 2023
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 1/2 study testing CLS-AX and Anti-VEGF in people with Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 11 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 4 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 to Week 12). The study lists 2 primary outcomes in all. 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 NCT04626128.

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 18 Sep 2023.

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