Trial Outcomes & Findings for Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (NCT NCT02595398)

Last Updated: 2021-05-28

Results Overview

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 in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

160 participants

Primary outcome timeframe

Baseline, 24 weeks

Results posted on

2021-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	4mg CLS-TA Suprachoriodal Injection Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Overall Study STARTED	96	64
Overall Study Intention-to-Treat (ITT) Population	96	64
Overall Study Safety Population	96	64
Overall Study COMPLETED	92	63
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	4mg CLS-TA Suprachoriodal Injection Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Overall Study Non-compliance	1	0
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4mg CLS-TA Suprachoriodal Injection n=96 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=64 Participants Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=5 Participants	52 Participants n=7 Participants	131 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	50.40 years STANDARD_DEVIATION 14.180 • n=5 Participants	50.00 years STANDARD_DEVIATION 15.083 • n=7 Participants	50.24 years STANDARD_DEVIATION 14.502 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	34 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	30 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	58 Participants n=7 Participants	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	44 Participants n=5 Participants	28 Participants n=7 Participants	72 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	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	25 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	46 participants n=5 Participants	34 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment Israel	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment India	43 participants n=5 Participants	27 participants n=7 Participants	70 participants n=5 Participants
Type of Uveitis Anterior uveitis	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Type of Uveitis Intermediate uveitis	34 Participants n=5 Participants	23 Participants n=7 Participants	57 Participants n=5 Participants
Type of Uveitis Posterior uveitis	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Type of Uveitis Panuveitis	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: The Intent-to-treat population included all randomized subjects who received at least one study treatment.

Outcome measures

Outcome measures
Measure	4mg CLS-TA Suprachoriodal Injection n=96 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=64 Participants Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	45 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: The Intent-to-treat population included all randomized subjects who received at least one study treatment. Analysis included all subjects with gradable reading center images.

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. Only images that were gradable by the central reading center were included in the analysis.

Outcome measures

Outcome measures
Measure	4mg CLS-TA Suprachoriodal Injection n=93 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=61 Participants Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Mean Change From Baseline in Central Subfield Thickness	-152.6 microns Standard Deviation 159.14	-17.9 microns Standard Deviation 150.98

SECONDARY outcome

Timeframe: Baseline to 24 weeks

Population: The Safety population included all randomized subjects who were administered at least one dose of the study drug.

Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit.

Outcome measures

Outcome measures
Measure	4mg CLS-TA Suprachoriodal Injection n=96 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=64 Participants Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Experiencing at least one TEAE	67 Participants	45 Participants
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Experiencing at least one SAE	3 Participants	0 Participants

Adverse Events

4mg CLS-TA Suprachoriodal Injection

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Sham Procedure

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	4mg CLS-TA Suprachoriodal Injection n=96 participants at risk Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=64 participants at risk Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Infections and infestations Sialoadenitis	1.0% 1/96 • Number of events 1 • Adverse events were collected over 24 weeks of follow-up.	0.00% 0/64 • Adverse events were collected over 24 weeks of follow-up.
Injury, poisoning and procedural complications Lumbar vertebral fracture	1.0% 1/96 • Number of events 1 • Adverse events were collected over 24 weeks of follow-up.	0.00% 0/64 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Retinal detachment	1.0% 1/96 • Number of events 1 • Adverse events were collected over 24 weeks of follow-up.	0.00% 0/64 • Adverse events were collected over 24 weeks of follow-up.

Other adverse events

Other adverse events
Measure	4mg CLS-TA Suprachoriodal Injection n=96 participants at risk Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints	Sham Procedure n=64 participants at risk Matching suprachoroidal syringe with sham procedure Sham Procedure: Sham procedure administered at 2 timepoints
Nervous system disorders Headache	5.2% 5/96 • Number of events 5 • Adverse events were collected over 24 weeks of follow-up.	3.1% 2/64 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Cataract subcapsular	7.3% 7/96 • Number of events 7 • Adverse events were collected over 24 weeks of follow-up.	4.7% 3/64 • Number of events 4 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Cystoid macular oedema	0.00% 0/96 • Adverse events were collected over 24 weeks of follow-up.	14.1% 9/64 • Number of events 11 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Eye pain	14.6% 14/96 • Number of events 18 • Adverse events were collected over 24 weeks of follow-up.	0.00% 0/64 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Ocular hypertension	2.1% 2/96 • Number of events 3 • Adverse events were collected over 24 weeks of follow-up.	7.8% 5/64 • Number of events 5 • Adverse events were collected over 24 weeks of follow-up.
Eye disorders Uveitis	2.1% 2/96 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up.	6.2% 4/64 • Number of events 4 • Adverse events were collected over 24 weeks of follow-up.
Investigations Intraocular pressure increased	6.2% 6/96 • Number of events 6 • Adverse events were collected over 24 weeks of follow-up.	3.1% 2/64 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up.

Additional Information

Thomas Ciulla, MD MBA

Clearside Biomedical, Inc.

Phone: (678) 392-2318

Email: [email protected]

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 the Sponsor.
Publication restrictions are in place

Restriction type: OTHER