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This is a single-arm, multicenter study to evaluate clinical usability of a pre-filled syringe containing SCD411 in adult patients with neovascular Wet Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), or Diabetic Retinopathy (DR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCD411 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD411 0.05mL (2mg) | Drug | Single intravitreal therapy (IVT) injection using a prefilled syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful task completions for product use tasks (from opening the carton to disposal of the used PFS and needle) | Successful completion is defined as achieving the correct results without a usage error. A usage error is defined as an action or lack of action by the user of the PFS that leads to a result that is not intended by the manufacturer | Baseline [Day 1] |
| Percentage of successful completions of safety-related critical tasks | Critical tasks are tasks that, if not performed correctly (or at all), would or could cause serious harm to the patient or user | Baseline [Day 1] |
| Percentage of successful completions of essential tasks | Essential tasks are tasks that are not critical but are required to complete the use process for effective use of SCD411 | Baseline [Day 1] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ocular adverse events (AEs) in the study eye | Baseline through follow up visit - approximately 7 (+2) days post injection | |
| Number of serious adverse events (SAEs) in the study eye | Baseline through follow up visit - approximately 7 (+2) days post injection |
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Inclusion Criteria:
Providers must meet all of the following criteria to be eligible for the study:
Patients must meet all of the following criteria to be eligible for the study:
Exclusion Criteria:
Patients meeting any of the following criteria will not be eligible for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Jhip Ha | Sam Chun Dang Pharm. Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Florida Eye Institute | Stuart | Florida | 34994 | United States | ||
| Center for Retina and Macular Disease |
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| Number of non-ocular SAEs | Baseline through follow up visit - approximately 7 (+2) days post injection |
| Winter Haven |
| Florida |
| 33880 |
| United States |
| University Retina & Macula Associates, P.C | Lemont | Illinois | 60439 | United States |
| Retina Vitreous Surgeons of Central New York, PC | Liverpool | New York | 13088 | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003925 | Diabetic Angiopathies |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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