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

Sponsor

Clearside Biomedical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02956330

Collaborator

(none)

Enrollment

Location

5.3

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Macular Edema Retinal Vein Occlusion

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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Apr 12, 2017

Actual Study Completion Date :

Apr 12, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Time to additional therapy for RVO [6 months following exit from Parent study]

Secondary Outcome Measures

Mean change from baseline for intraocular pressure [6 months following exit from Parent study]
Measured by applanation tonometry
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 in best corrected visual acuity [6 months following exit from Parent study]
Based on ETDRS