Trial Outcomes & Findings for Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study (NCT NCT05131646)
NCT ID: NCT05131646
Last Updated: 2024-03-04
Results Overview
The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
Day 1 to Week 24
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
5
|
|
Overall Study
Safety Population
|
3
|
7
|
5
|
|
Overall Study
COMPLETED
|
2
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Baseline characteristics by cohort
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
78.7 years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
87.9 years
STANDARD_DEVIATION 4.98 • n=7 Participants
|
79.6 years
STANDARD_DEVIATION 3.97 • n=5 Participants
|
83.3 years
STANDARD_DEVIATION 6.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Duration of nAMD Diagnosis in the Study Eye
|
56.63 months
STANDARD_DEVIATION 23.759 • n=5 Participants
|
67.29 months
STANDARD_DEVIATION 44.329 • n=7 Participants
|
36.42 months
STANDARD_DEVIATION 38.955 • n=5 Participants
|
54.87 months
STANDARD_DEVIATION 39.442 • n=4 Participants
|
|
Total Number of Prior nAMD Treatments in the Study Eye
0-2 Injections
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Total Number of Prior nAMD Treatments in the Study Eye
3-6 Injections
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Total Number of Prior nAMD Treatments in the Study Eye
7-12 Injections
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Total Number of Prior nAMD Treatments in the Study Eye
13-18 Injections
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Total Number of Prior nAMD Treatments in the Study Eye
>18 Injections
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Pre Injection Intraocular Pressure in the Study Eye at Baseline
|
14.3 mmHg
STANDARD_DEVIATION 1.53 • n=5 Participants
|
13.9 mmHg
STANDARD_DEVIATION 2.34 • n=7 Participants
|
13.8 mmHg
STANDARD_DEVIATION 3.56 • n=5 Participants
|
13.9 mmHg
STANDARD_DEVIATION 2.52 • n=4 Participants
|
|
Best Corrected Visual Acuity in the Study Eye at Baseline
|
61.0 letters
STANDARD_DEVIATION 8.19 • n=5 Participants
|
59.0 letters
STANDARD_DEVIATION 14.71 • n=7 Participants
|
71.2 letters
STANDARD_DEVIATION 2.17 • n=5 Participants
|
63.5 letters
STANDARD_DEVIATION 11.67 • n=4 Participants
|
|
Central Subfield Thickness in the Study Eye at Baseline
|
214.0 microns
STANDARD_DEVIATION 13.53 • n=5 Participants
|
201.9 microns
STANDARD_DEVIATION 24.38 • n=7 Participants
|
214.8 microns
STANDARD_DEVIATION 13.74 • n=5 Participants
|
208.6 microns
STANDARD_DEVIATION 19.43 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 24Population: 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.
The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 24Population: 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.
The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: 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.
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.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 4
|
14.7 microns
Standard Deviation 14.47
|
23.5 microns
Standard Deviation 23.82
|
20.2 microns
Standard Deviation 26.64
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 8
|
5.7 microns
Standard Deviation 30.37
|
28.2 microns
Standard Deviation 21.48
|
13.6 microns
Standard Deviation 18.08
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 12
|
53.3 microns
Standard Deviation 83.34
|
36.6 microns
Standard Deviation 34.02
|
19.4 microns
Standard Deviation 16.10
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 16
|
18.0 microns
Standard Deviation 19.80
|
5.1 microns
Standard Deviation 28.26
|
13.4 microns
Standard Deviation 15.49
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 20
|
67.0 microns
|
20.0 microns
Standard Deviation 21.84
|
26.2 microns
Standard Deviation 49.55
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
Week 24
|
6.0 microns
|
20.4 microns
Standard Deviation 33.10
|
26.4 microns
Standard Deviation 65.26
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: 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.
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.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 4
|
0.7 letters
Standard Deviation 2.08
|
1.0 letters
Standard Deviation 2.19
|
0.8 letters
Standard Deviation 2.49
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 8
|
-2.3 letters
Standard Deviation 2.08
|
2.5 letters
Standard Deviation 3.08
|
1.8 letters
Standard Deviation 2.86
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 12
|
-5.0 letters
Standard Deviation 10.82
|
-0.9 letters
Standard Deviation 2.85
|
0.0 letters
Standard Deviation 3.16
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 16
|
-2.0 letters
Standard Deviation 0.00
|
1.9 letters
Standard Deviation 3.02
|
1.0 letters
Standard Deviation 4.85
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 20
|
0.0 letters
Standard Deviation 1.41
|
0.0 letters
Standard Deviation 2.65
|
1.0 letters
Standard Deviation 6.20
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Week 24
|
-35.0 letters
Standard Deviation 46.67
|
-1.9 letters
Standard Deviation 5.05
|
0.4 letters
Standard Deviation 6.62
|
SECONDARY outcome
Timeframe: Day 1 to Week 24Population: 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.
Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 8
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 12
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 20
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Week 24
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
Day 1 to Week 24
|
3 Participants
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Week 24Population: 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.
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.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 20
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 24
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Day 1 to Week 24
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 8
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 12
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: 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.
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.
Outcome measures
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 Participants
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
|
Cohort 3 (High-mid Dose) Extension
n=7 Participants
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
|
Cohort 4 (High Dose) Extension
n=5 Participants
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
|
|---|---|---|---|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 4
|
-0.7 mmHg
Standard Deviation 4.16
|
-0.5 mmHg
Standard Deviation 0.84
|
0.2 mmHg
Standard Deviation 5.45
|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 8
|
0.3 mmHg
Standard Deviation 3.79
|
0.2 mmHg
Standard Deviation 1.72
|
1.6 mmHg
Standard Deviation 3.78
|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 12
|
0.3 mmHg
Standard Deviation 2.31
|
-0.1 mmHg
Standard Deviation 1.68
|
0.2 mmHg
Standard Deviation 3.90
|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 16
|
0.5 mmHg
Standard Deviation 3.54
|
0.4 mmHg
Standard Deviation 1.72
|
1.2 mmHg
Standard Deviation 2.49
|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 20
|
1.0 mmHg
Standard Deviation 0.00
|
-0.6 mmHg
Standard Deviation 0.98
|
0.0 mmHg
Standard Deviation 3.54
|
|
Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
Week 24
|
-1.0 mmHg
Standard Deviation 4.24
|
0.6 mmHg
Standard Deviation 1.99
|
0.4 mmHg
Standard Deviation 3.91
|
Adverse Events
Cohort 2 (Low-mid Dose) Extension
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 (High-mid Dose) Extension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 (High Dose) Extension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 2 (Low-mid Dose) Extension
n=3 participants at risk
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
|
Cohort 3 (High-mid Dose) Extension
n=7 participants at risk
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
|
Cohort 4 (High Dose) Extension
n=5 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Macular degeneration
|
33.3%
1/3 • Number of events 2 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Neovascular age-related degeneration
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Retinal haemorrhage
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Eye disorders
Subretinal fluid
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
|
Nervous system disorders
Transient ischaemic attack
|
33.3%
1/3 • Number of events 1 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/7 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
0.00%
0/5 • Adverse events were collected over 24 weeks following CLS-AX administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER