San Antonio, Texas, United States
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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
-
Time to additional therapy for RVO
Time frame: 6 months following exit from Parent study
Secondary outcomes
-
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
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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