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Completed

NCT Number: NCT02956330

Retrospective Study of the Safety and Efficacy of Patients 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Antonio, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Time to additional therapy for RVO

    Time frame: 6 months following exit from Parent study

Secondary outcomes

  1. Mean change from baseline for intraocular pressure

    Time frame: 6 months following exit from Parent study

    Measured by applanation tonometry

  2. Mean change from baseline in central subfield thickness

    Time frame: 6 months following exit from Parent study

    Based on spectral domain optical coherence tomography

  3. Mean change from baseline in best corrected visual acuity

    Time frame: 6 months following exit from Parent study

    Based on ETDRS

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2016
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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