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Clinical Trials/NCT02956330
NCT02956330
Completed
Not Applicable

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

Clearside Biomedical, Inc.0 sites20 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Macular Edema
Sponsor
Clearside Biomedical, Inc.
Enrollment
20
Primary Endpoint
Time to additional therapy for RVO
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
April 12, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to additional therapy for RVO

Time Frame: 6 months following exit from Parent study

Secondary Outcomes

  • Mean change from baseline in central subfield thickness(6 months following exit from Parent study)
  • Mean change from baseline for intraocular pressure(6 months following exit from Parent study)
  • Mean change from baseline in best corrected visual acuity(6 months following exit from Parent study)

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