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The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.
The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.
Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg CLS-TA | Experimental | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA |
|
| 0.8 mg CLS-TA | Experimental | Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg CLS-TA | Drug | 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis | 2 months |
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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 |
|---|---|---|---|---|---|---|
| Miami | Florida | 33136 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg CLS-TA | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
| FG001 | 0.8 mg CLS-TA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.8 mg CLS-TA | Drug | 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Chicago | Illinois | 60611 | United States |
| Boston | Massachusetts | 02114 | United States |
| Waltham | Massachusetts | 02451 | United States |
| Omaha | Nebraska | 68105 | United States |
| New York | New York | 10021 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cleveland | Ohio | 44195 | United States |
| Dallas | Texas | 75231 | United States |
Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA 0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg CLS-TA | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
| BG001 | 0.8 mg CLS-TA | Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA 0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis | Intent-to-Treat set includes all randomly assigned subjects who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Microns | 2 months |
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8 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 | 4 mg CLS-TA | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA 4 mg CLS-TA: 4 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | 0 | 17 | 1 | 17 | 14 | 17 |
| EG001 | 0.8 mg CLS-TA | Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA 0.8 mg CLS-TA: 0.8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anterior chamber cell | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Anterior chamber inflammation | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Blindness transient | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
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| Conjunctival oedema | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Dry eye | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Dry eye | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
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| Eye pain | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Keratitis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Macular oedema | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Macular oedema | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Ocular discomfort | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Punctate keratitis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Retinal artery occlusion | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Uveitis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Uveitis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
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| Injection site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Papillitis | General disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
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| Papillitis | General disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
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| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Intraocular pressure increased | Investigations | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ciulla, MD | Clearside Biomedical, Inc. | (678) 392-2318 | thomas.ciulla@clearsidebio.com |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| D015866 | Uveitis, Posterior |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D015867 | Uveitis, Intermediate |
| D000080324 | Choroidal Effusions |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005124 | Eye Abnormalities |
| D015862 | Choroid Diseases |
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| >=65 years |
|
| Male |
|