Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/24/2017 |
| Start Date: | November 2016 |
| End Date: | April 12, 2017 |
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).
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).
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.
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.
Inclusion Criteria:
- Completed enrollment and did not receive additional aflibercept therapy in the Parent
study, CLS1003-201
Exclusion Criteria:
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