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This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.
This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema.
Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | Experimental | Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | Drug | CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 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. | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure in the Study Eye | 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. | Baseline, 24 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina-Vitreous Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16196117 | Background | Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. | |
| 4000641 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2017 |
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|
| Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye | 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. | Baseline, 24 Weeks |
| Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye | 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. | Baseline, 24 Weeks |
| Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye | 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. | Baseline, 24 Weeks |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Northern California Retina Vitreous Associates Medical Group, Inc. | Mountain View | California | 94040 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Midwest Eye Retina Practicing at Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology. 1985 Apr;92(4):467-71. doi: 10.1016/s0161-6420(85)34001-0. |
| 21220619 | Background | Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10. |
| 36787524 | Derived | Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324. |
| 36399237 | Derived | Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18. |
| Intention-to-Treat Population | Defined as all patients eligible to be treated with CLS-TA (i.e., patients who did not fail screening and entered the study). |
|
| Safety Population | Defined as all patients who entered the study and were administered at least one dose of CLS-TA. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of patients in years relative to the date of the Screening visit. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Age, Continuous | Age of patients in years relative to the date of the Screening visit. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Type of Uveitis in the Study Eye | Location of inflammation in the study eye, including anterior (anterior chamber), intermediate (vitreous), posterior (retina or choroid) and panuveitis. | Count of Participants | Participants |
|
| 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 | Adverse Events | 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. | The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA | Posted | Count of Participants | Participants | Baseline to 24 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure in the Study Eye | 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. | The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 Weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye | 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. | The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA | Posted | Count of Participants | Participants | Baseline, 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye | 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. | The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA | Posted | Count of Participants | Participants | Baseline, 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye | 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. | The Safety Population included all patients who entered the study and were administered at least one dose of CLS-TA | Posted | Count of Participants | Participants | Baseline, 24 Weeks |
|
|
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.
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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 | 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 | 0 | 38 | 1 | 38 | 24 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Eye inflammation | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Eye inflammation | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Eye pain | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Ocular hypertension | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Cataract | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Cataract nuclear | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Cystoid macular oedema | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Eye irritation | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Vision blurred | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Visual impairment | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Non-systematic Assessment | # Fellow eye |
|
| Procedure headache | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
| Injection site pain | General disorders | MedDRA (19.0) | Non-systematic Assessment | # Study eye |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ciulla, MD MBA | Clearside Biomedical, Inc. | (678) 392-2318 | thomas.ciulla@clearsidebio.com |
| Apr 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D015866 | Uveitis, Posterior |
| D014606 | Uveitis, Anterior |
| D015867 | Uveitis, Intermediate |
| D015864 | Panuveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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Not provided
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Posterior uveitis |
|
| Panuveitis |
|
|
|
|
| Participants |
|
|