Trial Outcomes & Findings for Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema (NCT NCT02949024)
NCT ID: NCT02949024
Last Updated: 2021-05-13
Results Overview
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Over 6 months of follow-up
Results posted on
2021-05-13
Participant Flow
Participant milestones
| Measure |
TX Naïve Arm
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
TX Naïve Arm
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
62.5 Years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Baseline Best Corrected Visual Acuity
|
67.2 Letters
STANDARD_DEVIATION 11.66 • n=5 Participants
|
67.2 Letters
STANDARD_DEVIATION 8.95 • n=7 Participants
|
67.2 Letters
STANDARD_DEVIATION 10.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Over 6 months of follow-upPopulation: The Safety population included all subjects who received study treatment.
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
Outcome measures
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Number of participants with treatment emergent adverse events
|
8 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Number of participants with serious adverse events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The Intent-to-treat population included all subjects who received study treatment. No values were imputed for missing data.
Baseline and change from baseline at 6 months in intraocular pressure as measured by applanation tonometry
Outcome measures
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure
Baseline
|
14.2 mm Hg
Standard Deviation 3.52
|
13.3 mm Hg
Standard Deviation 2.50
|
|
Mean Change From Baseline in Intraocular Pressure
Month 6
|
-0.3 mm Hg
Standard Deviation 2.41
|
2.8 mm Hg
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The Intent-to-treat population included all subjects who received study treatment. No values were imputed for missing data.
Baseline and change from baseline at 6 months in central subfield thickness. 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 masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
Outcome measures
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness
Baseline
|
421.6 Microns
Standard Deviation 94.33
|
472.7 Microns
Standard Deviation 109.46
|
|
Mean Change From Baseline in Central Subfield Thickness
Month 6
|
-90.9 Microns
Standard Deviation 62.48
|
-119.6 Microns
Standard Deviation 65.48
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The Intent-to-treat population included all subjects who received study treatment.
Baseline and Change from baseline at 6 months in best corrected visual acuity before and after treatment Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured as the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
Outcome measures
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Best Corrected Visual Acuity
Baseline
|
67.2 Letters
Standard Deviation 11.66
|
67.2 Letters
Standard Deviation 8.95
|
|
Best Corrected Visual Acuity
Month 6
|
8.5 Letters
Standard Deviation 11.96
|
1.1 Letters
Standard Deviation 11.94
|
SECONDARY outcome
Timeframe: 2 to 6 months following initial treatment with study drugPopulation: The Intent-to-treat population included all subjects who received study treatment.
After the initial treatment with CLS-TA, with or without intravitreal aflibercept, at Baseline, retreatment with CLS-TA was allowed in either treatment group from Month 2 through Month 6 if pre-defined retreatment criteria were met. Number of patients receiving 0, 1, 2, 3, 4 or 5 retreatments with CLS-TA.
Outcome measures
| Measure |
TX Naïve Arm
n=10 Participants
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 Participants
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
CLS-TA Injections
0 additional injections
|
4 Participants
|
1 Participants
|
|
CLS-TA Injections
1 additional injection
|
2 Participants
|
3 Participants
|
|
CLS-TA Injections
2 additional injections
|
0 Participants
|
2 Participants
|
|
CLS-TA Injections
3 additional injections
|
2 Participants
|
0 Participants
|
|
CLS-TA Injections
4 additional injections
|
2 Participants
|
4 Participants
|
Adverse Events
TX Naïve Arm
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Previous TX Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TX Naïve Arm
n=10 participants at risk
Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.
IVT Aflibercept: IVT aflibercept \[2 mg (50 µL)\]
SC CLS-TA: \[4 mg (100 µL)\]
|
Previous TX Arm
n=10 participants at risk
Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.
SC CLS-TA: \[4 mg (100 µL)\]
|
|---|---|---|
|
Eye disorders
Cataract
|
20.0%
2/10 • Number of events 2 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
Conjunctival haemorrhage
|
30.0%
3/10 • Number of events 3 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
Episcleritis
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
Iritis
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Investigations
Intraocular pressure increased
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution and investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical.
- Publication restrictions are in place
Restriction type: OTHER