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This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triamcinolone acetonide (Triesence®) | Experimental | TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triamcinolone acetonide (Triesence®) | Drug | 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 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. | Change from baseline in IOP at 8 weeks |
| Best Corrected Visual Acuity | 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. | Change from baseline at 8 weeks and 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Central Subfield Thickness Using Optical Coherence Tomography (OCT) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ciulla, MD | Clearside Biomedical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Nebraska Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27980877 | Derived | Goldstein DA, Do D, Noronha G, Kissner JM, Srivastava SK, Nguyen QD. Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. Transl Vis Sci Technol. 2016 Dec 14;5(6):14. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change from baseline at 8 weeks and 26 weeks. |
| Vitreous Haze Grade | 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. | Change from baseline at 8 weeks and 26 weeks |
| Omaha |
| Nebraska |
| 68198 |
| United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects who received at least one attempted dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) | 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. | Safety population including all subjects who received at least one attempted dose of study drug. | Posted | Mean | Standard Deviation | mm Hg | Change from baseline in IOP at 8 weeks |
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| Primary | Best Corrected Visual Acuity | 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. | Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded. | Posted | Mean | Standard Deviation | logMAR | Change from baseline at 8 weeks and 26 weeks. |
| |||||||||||||||||||||||||||
| Secondary | Central Subfield Thickness Using Optical Coherence Tomography (OCT) | 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. | Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded. | Posted | Mean | Standard Deviation | Microns | Change from baseline at 8 weeks and 26 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Vitreous Haze Grade | 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. | Per protocol population including all subjects who received at least one attempted dose of study drug. Data post-rescue was excluded. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 8 weeks and 26 weeks |
|
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26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 11 | 1 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v.17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Cystoid macular oedema | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
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| Cystoid macular oedema | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Fellow eye |
|
| Eye irritation | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Eye pain | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Eyelid margin crusting | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Punctate keratitis | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Retinal ischaemia | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Retinal neovascularisation | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Uveitis | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Vision blurred | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye; both events occurred in a subject who received 0 µL of study drug. |
|
| Visual acuity reduced | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (17.1) | Non-systematic Assessment | #Fellow eye |
|
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment | #Event occurred in a subject who received 0 µL of study drug. |
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| Localised infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment | #Both events occurred in a subject who received 0 µL of study drug. |
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| Sinusitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment | #Event occurred in a subject who received 0 µL of study drug. |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment | #Event occurred in a subject who received 0 µL of study drug. |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Psychological trauma | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment | #Event occurred in a subject who received 0 µL of study drug. |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (17.1) | Non-systematic Assessment | #Study eye; event occurred in a subject who received 0 µL of study drug. |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ciulla, MD | Clearside Biomedical, Inc. | (678) 392-2318 | thomas.ciulla@clearsidebio.com |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D015867 | Uveitis, Intermediate |
| D015866 | Uveitis, Posterior |
| D015864 | Panuveitis |
| D000080324 | Choroidal Effusions |
| D007249 | Inflammation |
| D009879 | Ophthalmia, Sympathetic |
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D005124 | Eye Abnormalities |
| D015862 | Choroid Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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