Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Next RVO therapy administered (if applicable), including reason for treatment Continued documentation of current or changes in medical or ocular conditions following parent study Concomitant drug or therapy changes Visual acuity, including details on the method used in the assessment Central retinal thickness, including details on the equipment used in its determination Intraocular pressure, including details on the equipment used in its determination 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.

Official Title
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Retrospective Study of the Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept for the Treatment of Macular Edema Associated With RVO in Subjects Who Completed Parent Study CLS1003-201

Conditions
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Macular Edema, Retinal Vein Occlusion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201 Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLS1003-201<br>Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to additional therapy for RVO |  | 6 months following exit from Parent study | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, RVO, ME, Central Subfield Thickness, Optical Coherence Tomography, Cystoid Macular Edema, Subretinal Fluid, Eylea, Aflibercept, Anti-VEGF