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

Clearside Biomedical

Status: Completed

Conditions: Macular Edema; Retinal Vein Occlusion

Study type: Observational

Funder types: Industry

Identifiers

NCT02956330

CLS1003-202

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

20 participants in 1 patient group

CLS1003-201

Description:

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