Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02956330

Enrollment

Registered

2016-11-07

Start date

2016-11-30

Completion date

2017-04-12

Last updated

2019-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame
Time to additional therapy for RVO	6 months following exit from Parent study

Secondary

Measure	Time frame	Description
Mean change from baseline for intraocular pressure	6 months following exit from Parent study	Measured by applanation tonometry
Mean change from baseline in central subfield thickness	6 months following exit from Parent study	Based on spectral domain optical coherence tomography
Mean change from baseline in best corrected visual acuity	6 months following exit from Parent study	Based on ETDRS

Countries

United States

Outcome results