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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Low Dose) | Experimental | Subjects will receive a low dose of 0.03 mg CLS-AX |
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| Cohort 2 (Low-mid Dose) | Experimental | Subjects will receive a low-mid dose of 0.10 mg CLS-AX |
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| Cohort 3 (High-mid Dose) | Experimental | Subjects will receive a high-mid dose of 0.50 mg CLS-AX |
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| Cohort 4 (High Dose) | Experimental | Subjects will receive a high-mid dose of 1.0 mg CLS-AX |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS-AX | Drug | injectable suspension of small molecule tyrosine kinase inhibitor (TKI) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Week 12 |
| 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. | Day 1 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | ||
| California Retina Consultants |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Low Dose) | Subjects will receive a low dose of 0.03 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| FG001 | Cohort 2 (Low-mid Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 15, 2022 |
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Four groups of approximately 5 participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.
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| Anti-VEGF | Drug | Standard of care therapy used to block vascular endothelial growth factor |
|
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| Weeks 4, 8 and 12. |
| 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. | From Day 1 to Week 12 |
| 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. | Day 1 to Week 12 |
| 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. | Weeks 4, 8 and 12 |
| 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. | Weeks 4, 8 and 12 |
| 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. | Day 1 to Week 12 |
| Bakersfield |
| California |
| 93309 |
| United States |
| Northern California Retina Vitreous Associates Medical Group, LLC | Mountain View | California | 94040 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |
Subjects will receive a low-mid dose of 0.10 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| FG002 | Cohort 3 (High-mid Dose) | Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| FG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| Safety Population | Defined as all enrolled participants who were administered CLS-AX, and from whom at least one post-Baseline safety measurement was obtained. |
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| Pharmacokinetic Population | Defined as all participants that provide plasma samples for axitinib concentration analysis. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Low Dose) | Subjects will receive a low dose of 0.03 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| BG001 | Cohort 2 (Low-mid Dose) | Subjects will receive a low-mid dose of 0.10 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| BG002 | Cohort 3 (High-mid Dose) | Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| BG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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. 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. | Mean | Standard Deviation | microns |
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| 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) | 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, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Count of Participants | Participants | Day 1 to Week 12 |
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| Primary | 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. | Defined as all enrolled participants who were administered CLS-AX, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Count of Participants | Participants | Day 1 to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Mean | Standard Deviation | mmHg | Weeks 4, 8 and 12. |
| ||||||||||||||||||||||||||||||||||||
| 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. 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. | Defined as all enrolled participants who were administered CLS-AX, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Count of Participants | Participants | From Day 1 to Week 12 |
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| Secondary | 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, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Count of Participants | Participants | Day 1 to Week 12 |
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| Secondary | 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. | Defined as all enrolled participants who were administered CLS-AX, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Mean | Standard Deviation | microns | Weeks 4, 8 and 12 |
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| Secondary | 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. | Defined as all enrolled participants who were administered CLS-AX, and from whom at least one post-Baseline safety measurement was obtained. | Posted | Mean | Standard Deviation | letters | Weeks 4, 8 and 12 |
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| Secondary | 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. | Defined as all participants that provide plasma samples for axitinib concentration analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 1 to Week 12 |
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Adverse events were collected over 12 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 1 (Low Dose) | Subjects will receive a low dose of 0.03 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Cohort 2 (Low-mid Dose) | Subjects will receive a low-mid dose of 0.10 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | Cohort 3 (High-mid Dose) | Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor | 0 | 8 | 0 | 8 | 3 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (23.1) | Non-systematic Assessment | Study eye |
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| 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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| Cystitis | 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 |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (23.1) | Non-systematic Assessment |
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All information concerning CLS1002-101 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Coultas, PhD | Clearside Biomedical, Inc. | 678.270.3639 | susan.coultas@clearsidebio.com |
| Jul 27, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3-6 injections |
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| 7-12 injections |
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| 13-18 injections |
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| >18 injections |
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| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
|
| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
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| OG002 | Cohort 3 (High-mid Dose) | Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
|
Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
|
Subjects will receive a high-mid dose of 0.50 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
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| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
|
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| OG003 | Cohort 4 (High Dose) | Subjects will receive a high-mid dose of 1.0 mg CLS-AX CLS-AX: injectable suspension of small molecule tyrosine kinase inhibitor (TKI) Anti-VEGF: Standard of care therapy used to block vascular endothelial growth factor |
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