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A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg CLS-TA + IVT aflibercept | Experimental | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept |
|
| sham + IVT aflibercept | Active Comparator | Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept |
|
| 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 |
|---|---|---|
| Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm | 3 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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85014 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Suprachoroidal CLS-TA + IVT Aflibercept | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham | Drug | suprachoroidal sham procedure |
|
|
| IVT aflibercept | Drug | 2 mg intravitreal injection of aflibercept |
|
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| San Diego | California | 92037 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Atlanta | Georgia | 30322 | United States |
| Baltimore | Maryland | 21287 | United States |
| St Louis | Missouri | 63128 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Abilene | Texas | 79606 | United States |
| Houston | Texas | 77030 | United States |
| McAllen | Texas | 78503 | United States |
| San Antonio | Texas | 78251 | United States |
| The Woodlands | Texas | 77384 | United States |
| Suprachoroidal Sham + IVT Aflibercept |
Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| COMPLETED |
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| NOT COMPLETED |
|
The Intent-to-Treat set included all randomly assigned subjects who were treated and had at least one post-Baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Suprachoroidal CLS-TA + IVT Aflibercept | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| BG001 | Suprachoroidal Sham + IVT Aflibercept | Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| 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 |
| |||||||||||||||||
| 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 | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm | The Intent-to-Treat set included all randomly assigned subjects who were treated and had at least one post-Baseline assessment. | Posted | Count of Participants | Participants | 3 months |
|
|
|
3 months
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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 | Suprachoroidal CLS-TA + IVT Aflibercept | Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept | 0 | 23 | 0 | 23 | 12 | 23 |
| EG001 | Suprachoroidal Sham + IVT Aflibercept | Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept | 0 | 23 | 0 | 23 | 10 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Cataract | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Corneal oedema | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Eye pain | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Lacrimation increased | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Macular fibrosis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Ocular discomfort | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Ocular hypertension | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Optic disc vascular disorder | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Optic nerve disorder | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Punctate keratitis | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Retinal degeneration | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Retinal degeneration | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Retinal exudates | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Retinopathy | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Vision blurred | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Vision blurred | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Fellow eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Vitreous detachment | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Vitreous floaters | Eye disorders | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (17.0) | Non-systematic Assessment | #Study eye |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
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 |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| C533178 | aflibercept |
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| >=65 years |
|
| Male |
|
| 2 |
|
| 3 |
|