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

December 19, 2019 updated by: Clearside Biomedical, Inc.

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include approximately 30 adult subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clearside Biomedical, Inc.

Investigators

Study Director: Thomas Ciulla, MD, Clearside Biomedical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

April 12, 2017

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria