Trial Outcomes & Findings for Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis (NCT NCT03097315)

NCT ID: NCT03097315

Last Updated: 2021-06-23

Results Overview

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 38 participants
• Primary outcome timeframe: Baseline to 24 weeks
• Results posted on: 2021-06-23

Participant Flow

Participant milestones

Measure	4 mg CLS-TA Suprachoriodal Injection Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Overall Study STARTED	38
Overall Study Intention-to-Treat Population	38
Overall Study Safety Population	38
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	4 mg CLS-TA Suprachoriodal Injection Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

Baseline characteristics by cohort

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants
Type of Uveitis in the Study Eye Anterior uveitis	12 Participants n=5 Participants
Type of Uveitis in the Study Eye Intermediate uveitis	15 Participants n=5 Participants
Type of Uveitis in the Study Eye Posterior uveitis	10 Participants n=5 Participants
Type of Uveitis in the Study Eye Panuveitis	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Population: The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

Outcome measures

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Adverse Events Treatment-Emergent Adverse Events	27 Participants
Adverse Events Serious Adverse Events	1 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA

Intraocular pressure is the fluid pressure inside the eye. Tonometry is the method eye care professionals use to determine this. IOP is an important aspect in the evaluation of patients at risk of glaucoma. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.

Outcome measures

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Mean Intraocular Pressure in the Study Eye Baseline	13.3 mmHg Standard Deviation 3.57
Mean Intraocular Pressure in the Study Eye Week 24	15.2 mmHg Standard Deviation 4.40

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of cellular reaction in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber cells were graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the cells in the field: 0 = <1, 0.5+ = 1-5, 1+ = 6-15, 2+ = 16-25, 3+ = 26-50, and 4+ = >50 cells. A lower grade represents less inflammation in the eye.

Outcome measures

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye Baseline	17 Participants
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye Week 24	31 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA

The anterior chamber is the aqueous humor-filled space inside the eye between the iris and the cornea's innermost surface, the endothelium. The grading of intraocular inflammation or flare in the anterior chamber helps in the assessment of the severity of uveitis. In this study, anterior chamber flare was graded following the Standardization of Uveitis Nomenclature working group recommendations. The following scale was used to grade the flare: 0 = none, 1+ = faint, 2+ moderate (iris and lens details clear), 3+ = marked (iris and lens details hazy), 4+ = intense (fibrin or plastic aqueous). A lower grade represents less inflammation in the eye.

Outcome measures

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye Baseline	27 Participants
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye Week 24	34 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA

The vitreous body is that part of the eye that fills the space in the center of the eye. The primary purpose of the vitreous body is to keep the center of the eye clear so that light can get to the retina and vision can begin. Vitreous haze involves the obstruction of the back of the eye by vitreous cells and protein exudation. In this study, vitreous haze was graded following a standardized photographic scale ranging from 0 to 4. The following scale was used to grade the vitreous haze: 0 = no inflammation, +0.5 = trace inflammation, +1 = mild blurring of the retinal vessels and optic nerve, +1.5 = optic nerve head and posterior retina view obscuration greater than +1 but less than +2, +2 = moderate blurring of the optic nerve head, +3 = marked blurring of the optic nerve head, +4 = optic nerve head not visible. A lower grade represents less inflammation in the eye.

Outcome measures

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 Participants Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye Baseline	17 Participants
Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye Week 24	34 Participants

Adverse Events

4 mg CLS-TA Suprachoriodal Injection

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 participants at risk Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Eye disorders Visual acuity reduced	2.6% 1/38 • Number of events 1 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.

Other adverse events

Measure	4 mg CLS-TA Suprachoriodal Injection n=38 participants at risk Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA 4 mg CLS-TA Suprachoriodal Injection: CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
Eye disorders Conjunctival haemorrhage	13.2% 5/38 • Number of events 5 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Eye inflammation	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Eye pain	7.9% 3/38 • Number of events 5 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Ocular hypertension	5.3% 2/38 • Number of events 3 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Visual acuity reduced	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Cataract	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Cataract nuclear	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Cystoid macular oedema	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Eye irritation	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Vision blurred	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Eye disorders Visual impairment	5.3% 2/38 • Number of events 2 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Investigations Intraocular pressure increased	10.5% 4/38 • Number of events 4 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
Injury, poisoning and procedural complications Procedure headache	7.9% 3/38 • Number of events 4 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.
General disorders Injection site pain	5.3% 2/38 • Number of events 3 • Adverse events were collected over 24 weeks of follow-up. Treatment-emergent adverse events were defined as any adverse event occurring on or after the first dose of study drug or worsening from the pre-dose state.

Additional Information

Thomas Ciulla, MD MBA

Clearside Biomedical, Inc.

Phone: (678) 392-2318

Email: thomas.ciulla@clearsidebio.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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