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The purpose of this non interventional retrospective study is to continue to collect data from patients following their completion of Protocol CLS 1003-201: "Safety and Efficacy of Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following Retinal Vein Occlusion" (ie, the parent study).
This is a non-interventional, retrospective study of up to 6 months for subjects that completed the parent study CLS1003-201. This study is designed to collect data from patients following their parent study exit visit, through either the time of the next treatment for RVO or at least 6 months following the parent study exit visit, whichever occurs first.
During this non-interventional retrospective study, the following data will be collected in an online questionnaire (or where required, on paper) provided by Clearside:
Subjects will be selected based on parent study primary investigator's access to their medical records access, following exit from CLS1003-201. Data will also be collected on the total number of patients included in this non interventional study as well as reasons patients were excluded. Data will be summarized from the randomization treatment assignment in the parent study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS1003-201 | Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to additional therapy for RVO | 6 months following exit from Parent study |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline for intraocular pressure | Measured by applanation tonometry | 6 months following exit from Parent study |
| Mean change from baseline in central subfield thickness | Based on spectral domain optical coherence tomography |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include approximately 30 adult subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ciulla, MD | Clearside Biomedical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 6 months following exit from Parent study |
| Mean change from baseline in best corrected visual acuity | Based on ETDRS | 6 months following exit from Parent study |
| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |