Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
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|ClinicalTrials.gov Identifier: NCT02956330|
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : June 23, 2017
|Condition or disease|
|Macular Edema Retinal Vein Occlusion|
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|
|Actual Enrollment :||20 participants|
|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 :||November 2016|
|Actual Primary Completion Date :||April 12, 2017|
|Actual Study Completion Date :||April 12, 2017|
Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.
- Time to additional therapy for RVO [ Time Frame: 6 months following exit from Parent study ]
- Mean change from baseline for intraocular pressure [ Time Frame: 6 months following exit from Parent study ]Measured by applanation tonometry
- Mean change from baseline in central subfield thickness [ Time Frame: 6 months following exit from Parent study ]Based on spectral domain optical coherence tomography
- Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months following exit from Parent study ]Based on ETDRS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956330
|United States, Texas|
|San Antonio, Texas, United States|
|Study Director:||Jennifer Kissner, PhD||Clearside Biomedical, Inc.|