NCT02956330

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

November 3, 2016

Last Update Submit

December 19, 2019

Conditions

Macular EdemaRetinal Vein Occlusion

Keywords

RVOMECentral Subfield ThicknessOCTOptical Coherence TomographyCystoid Macular EdemaSubretinal FluidEyleaAfliberceptAnti-VEGF

Outcome Measures

Primary Outcomes (1)

  • Time to additional therapy for RVO

    6 months following exit from Parent study

Secondary Outcomes (3)

  • Mean change from baseline for intraocular pressure

    6 months following exit from Parent study

  • Mean change from baseline in central subfield thickness

    6 months following exit from Parent study

  • Mean change from baseline in best corrected visual acuity

    6 months following exit from Parent study

Study Arms (1)

CLS1003-201

Those subjects whose parent study primary investigator has access to their medical records, following exit from CLS1003-201.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Macular EdemaRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Ciulla, MD

    Clearside Biomedical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

November 1, 2016

Primary Completion

April 12, 2017

Study Completion

April 12, 2017

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations

US(1)