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

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion

• Registration Number: NCT02956330
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to additional therapy for RVO	6 months following exit from Parent study

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in central subfield thickness	6 months following exit from Parent study	Based on spectral domain optical coherence tomography
Mean change from baseline for intraocular pressure	6 months following exit from Parent study	Measured by applanation tonometry
Mean change from baseline in best corrected visual acuity	6 months following exit from Parent study	Based on ETDRS