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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS-AX | Drug | injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Participants who completed cohort 2 or 3 or 4 of CLS1002-101
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| Name | Affiliation | Role |
|---|---|---|
| Susan Coultas, PhD | Clearside Biomedical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Northern California Retina Vitreous Associates Medical Group, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| FG001 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| FG002 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Count of Participants | Participants | Day 1 to Week 24 |
|
Adverse events were collected over 24 weeks following CLS-AX administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Coultas, PhD | Clearside Biomedical, Inc. | 678.270.3639 | susan.coultas@clearsidebio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 | Jul 27, 2023 | Prot_SAP_000.pdf |
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|
| 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. | 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. | Day 1 to Week 24 |
| Day 1 to Week 24 |
| 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. | Weeks 4, 8, 12, 16, 20 and 24 |
| Mountain View |
| California |
| 94040 |
| United States |
| Retina Consultants Medical Group, Inc | Sacramento | California | 95825 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
| BG001 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| BG002 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of nAMD Diagnosis in the Study Eye | Mean | Standard Deviation | months |
|
| Total Number of Prior nAMD Treatments in the Study Eye | Count of Participants | Participants |
|
| Pre Injection Intraocular Pressure in the Study Eye at Baseline | 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. | Mean | Standard Deviation | mmHg |
|
| Best Corrected Visual Acuity in the Study Eye at Baseline | Best corrected visual acuity (BCVA) at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity. | Mean | Standard Deviation | letters |
|
| Central Subfield Thickness in the Study Eye at Baseline | 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. Only images that were gradable by the central reading center were included in the analysis. | Mean | Standard Deviation | microns |
|
| OG001 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
| OG002 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 |
|
|
| Primary | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Count of Participants | Participants | Day 1 to Week 24 |
|
|
|
| Secondary | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Mean | Standard Deviation | microns | Weeks 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Mean | Standard Deviation | letters | Weeks 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Count of Participants | Participants | Day 1 to Week 24 |
|
|
|
| Other Pre-specified | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Count of Participants | Participants | Day 1 to Week 24 |
|
|
|
| Other Pre-specified | 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. | Defined as all enrolled participants who were administered CLS-AX in the Parent study, who have provided informed consent for participating in the Extension study, and from whom at least one safety measurement was obtained after the participant provided informed consent. | Posted | Mean | Standard Deviation | mmHg | Weeks 4, 8, 12, 16, 20 and 24 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | 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. CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101 | 0 | 5 | 0 | 5 | 1 | 5 |
| Conjunctival haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
|
| Conjunctival oedema | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| Macular degeneration | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| Neovascular age-related degeneration | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| Retinal haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| Subretinal fluid | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| COVID-19 | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
|
All information concerning CLS1002-102 and the operations of Clearside Biomedical, Inc. are considered CONFIDENTIAL and shall remain the sole property of Clearside Biomedical Inc. The institutions and Investigators participating in this study shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical, Inc.
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