Trial Outcomes & Findings for Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis (NCT NCT01789320)

Last Updated: 2021-02-21

Results Overview

Intraocular pressure is the fluid pressure inside the eye. Intraocular pressure change from baseline at week 8 was measured by Goldmann applanation tonometry. Tonometry is the method eye care professionals use to determine this pressure. Intraocular pressure is typically measured in millimeters of mercury. A higher pressure inside the eye can be a risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. A negative change indicates a reduction in intraocular pressure.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Change from baseline in IOP at 8 weeks

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Triamcinolone Acetonide (Triesence®) TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Triamcinolone Acetonide (Triesence®) TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Overall Study Re-enrolled into study	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triamcinolone Acetonide (Triesence®) n=11 Participants TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 9.47 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 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	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline in IOP at 8 weeks

Population: Safety population including all subjects who received at least one attempted dose of study drug.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide (Triesence®) n=10 Participants TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Change in Intraocular Pressure (IOP)	-0.1 mm Hg Standard Deviation 3.21

PRIMARY outcome

Timeframe: Change from baseline at 8 weeks and 26 weeks.

Population: Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded.

Visual acuity (VA) rates a person's ability to recognize small details with precision. Best corrected VA refers to this measurement when the best vision has be achieved following refraction. Visual acuity change from baseline at 8 and 26 weeks was measured following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol using standardized lighting and lanes and an ETDRS eye chart. This eye chart comprises rows of letters, with 5 letters per row, and with the letter size from line to line varying logarithmically and is used to estimate visual acuity. Visual acuity is scored with reference to the logarithm of the minimum angle of resolution or logMAR. Zero logMAR indicates standard vision, positive values indicate poor vision and negative values indicate good vision. A negative changes indicates an improvement in visual acuity.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide (Triesence®) n=8 Participants TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Best Corrected Visual Acuity Week 8	-0.25 logMAR Standard Deviation 0.107
Best Corrected Visual Acuity Week 26	-0.28 logMAR Standard Deviation 0.096

SECONDARY outcome

Timeframe: Change from baseline at 8 weeks and 26 weeks.

Population: Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded.

Central subfield thickness (CST) is a measure of the thickness of the retina in the 1 mm diameter circle centered on the fovea or center of the macular where eyesight is the sharpest. CST change from baseline at 8 and 26 weeks was measured using optical coherence tomography (OCT). OCT is a diagnostic imaging technique used to capture 2 and 3 dimensional images within biological tissue, e.g., for determining the amount of edema contained in the retina. CST is typically measured in microns. A negative change represents a reduction in retinal thickness and an improvement in cases of retinal edema.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide (Triesence®) n=7 Participants TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Central Subfield Thickness Using Optical Coherence Tomography (OCT) Week 8	-153.7 Microns Standard Deviation 109.45
Central Subfield Thickness Using Optical Coherence Tomography (OCT) Week 26	-107.0 Microns Standard Deviation 86.95

SECONDARY outcome

Timeframe: Change from baseline at 8 weeks and 26 weeks

Population: Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded.

Vitreous haze scale (Nussenblatt 1985 as modified in Lowder 2011). Scores include value 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), and +4 (optic nerve head not visible) A higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide (Triesence®) n=8 Participants TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Vitreous Haze Grade Week 8	-0.75 score on a scale Standard Deviation 0.463
Vitreous Haze Grade Week 26	-0.75 score on a scale Standard Deviation 0.289

Adverse Events

Triamcinolone Acetonide (Triesence®)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Triamcinolone Acetonide (Triesence®) n=11 participants at risk TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	9.1% 1/11 • Number of events 1 • 26 weeks

Other adverse events

Other adverse events
Measure	Triamcinolone Acetonide (Triesence®) n=11 participants at risk TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) triamcinolone acetonide (Triesence®): 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
Eye disorders Cataract	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Cystoid macular oedema	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Eye irritation	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Eye pain	45.5% 5/11 • Number of events 6 • 26 weeks
Eye disorders Eyelid margin crusting	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Punctate keratitis	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Retinal ischaemia	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Retinal neovascularisation	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Uveitis	9.1% 1/11 • Number of events 1 • 26 weeks
Eye disorders Vision blurred	9.1% 1/11 • Number of events 2 • 26 weeks
Eye disorders Visual acuity reduced	9.1% 1/11 • Number of events 1 • 26 weeks
General disorders Pyrexia	9.1% 1/11 • Number of events 1 • 26 weeks
Infections and infestations Localised infection	18.2% 2/11 • Number of events 2 • 26 weeks
Infections and infestations Sinusitis	9.1% 1/11 • Number of events 1 • 26 weeks
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • 26 weeks
Injury, poisoning and procedural complications Ligament injury	9.1% 1/11 • Number of events 1 • 26 weeks
Injury, poisoning and procedural complications Ligament sprain	9.1% 1/11 • Number of events 1 • 26 weeks
Injury, poisoning and procedural complications Tendon injury	9.1% 1/11 • Number of events 1 • 26 weeks
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Number of events 1 • 26 weeks
Nervous system disorders Headache	18.2% 2/11 • Number of events 3 • 26 weeks
Psychiatric disorders Psychological trauma	9.1% 1/11 • Number of events 1 • 26 weeks
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	9.1% 1/11 • Number of events 1 • 26 weeks
Skin and subcutaneous tissue disorders Alopecia	9.1% 1/11 • Number of events 1 • 26 weeks
Surgical and medical procedures Cataract operation	9.1% 1/11 • Number of events 1 • 26 weeks

Additional Information

Thomas Ciulla, MD

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 Clearside Biomedical (or designee).
Publication restrictions are in place

Restriction type: OTHER