Neovascular Age-related Macular DegenerationNCT05131646
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
An observational study of Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 7 sites in United States.
Trial summary
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- CLS-AX
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Oct 2021to 5 Jan 2023
- Phase
- Observational
- 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
Study population: Participants who completed cohort 2 or 3 or 4 of CLS1002-101
Who may be able to join
- Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.
Who cannot join
- Received prohibited medication in the Parent study, CLS1002-101.
- Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
- Females of childbearing potential who are pregnant and or lactating.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Southeast Retina Center
Augusta, Georgia, 30909
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
Retina Consultants Medical Group, Inc
Sacramento, California, 95825
Retina Consultants of Texas
The Woodlands, Texas, 77384
About this study
Official title: Extension Study to Evaluate the Long-term Outcomes of Subjects Following CLS-AX Administration for Age-related Macular Degeneration in the CLS-AX CLS1002-101 Study
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.
Read the detailed description
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.
Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.
- Being tested
- CLS-AX
- Keywords
- AMD, Wet-AMD, suprachoroidal, tyrosine kinase inhibitor, nAMD, 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) administered in the Parent study CLS1002-101
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 (Low-mid Dose) Extension | Subjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. Receives: Drug: CLS-AX | |
| Cohort 3 (High-mid Dose) Extension | Subjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. Receives: Drug: CLS-AX | |
| Cohort 4 (High Dose) Extension | Subjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. Receives: Drug: CLS-AX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Measured: Day 1 to Week 24
Number of Participants With Serious Adverse Events (SAEs)
The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
Measured: Day 1 to Week 24
Secondary outcomes (3)
Mean Change From Baseline 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, 12, 16, 20 and 24
Mean Change From Baseline 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, 12, 16, 20 and 24
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.
Measured: Day 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start8 Oct 2021
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clearside Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Coultas, PhD, Study director, Clearside Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131646
- Sponsor's protocol ID
- CLS1002-102
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2021
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study to Evaluate the Long-term Outcomes of Subjects Following CLS-AX Administration for Age-related Macular Degeneration in the CLS-AX CLS1002-101 Study
- ClinicalTrials.gov ID
- NCT05131646
- Acronym / sponsor ID
- CLS1002-102
- Keywords
- AMD, Wet-AMD, suprachoroidal, tyrosine kinase inhibitor, nAMD, SCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Clearside Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.
Detailed description
This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.
Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 (Low-mid Dose) Extension | – | Drug: CLS-AXSubjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. |
| Cohort 3 (High-mid Dose) Extension | – | Drug: CLS-AXSubjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. |
| Cohort 4 (High Dose) Extension | – | Drug: CLS-AXSubjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who completed cohort 2 or 3 or 4 of CLS1002-101
Key inclusion criteria (1 listed)
- Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.
Key exclusion criteria (3 listed)
- Received prohibited medication in the Parent study, CLS1002-101.
- Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
- Females of childbearing potential who are pregnant and or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLS-AXAlso: axitinib injectable suspensioninjectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 | Drug | Cohort 2 (Low-mid Dose) Extension, Cohort 3 (High-mid Dose) Extension, Cohort 4 (High Dose) Extension |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Week 24
The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 to Week 24
The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
3 secondary outcomes
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Time frame: Day 1 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Coultas, PhD study director
Clearside Biomedical, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Clearside Biomedical, Inc. at 7 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 1 inclusion and 3 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). 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 24). 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?
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 4 Mar 2024.