Clinical trial NCT02956330: Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Retinal Vein Occlusion
Keywords: RVO
ME
Central Subfield Thickness
OCT
Optical Coherence Tomography
Cystoid Macular Edema
Subretinal Fluid
Eylea
Aflibercept
Anti-VEGF
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include approximately 30 adult subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Time to additional therapy for RVO
timeFrame: 6 months following exit from Parent study
Secondary outcomes:
measure: Mean change from baseline for intraocular pressure
timeFrame: 6 months following exit from Parent study
measure: Mean change from baseline in central subfield thickness
timeFrame: 6 months following exit from Parent study
measure: Mean change from baseline in best corrected visual acuity
timeFrame: 6 months following exit from Parent study
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References: