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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-04-12

Brief Summary

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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

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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.

Conditions

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Macular Edema Retinal Vein Occlusion

Keywords

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RVO ME Central Subfield Thickness OCT Optical Coherence Tomography Cystoid Macular Edema Subretinal Fluid Eylea Aflibercept Anti-VEGF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CLS1003-201

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Ciulla, MD

Role: STUDY_DIRECTOR

Clearside Biomedical, Inc.

Locations

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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLS1003-202

Identifier Type: -

Identifier Source: org_study_id