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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Retinal Consultants of Arizona
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Northern California Retina Vitreous Associates Medical Group, LLC
Mountain View, California, United States
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.
Time frame: 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.
Time frame: Day 1 to Week 12
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.
Time frame: 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.
Time frame: From Day 1 to Week 12
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
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Retinal Consultants Medical Group
Sacramento, California, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
...and 1 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Week 12