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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956330
• Other study ID #: CLS1003-202
• Status: Completed
• Start date: November 2016
• Est. completion date: April 12, 2017

Study information

• Verified date: December 2019
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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