Outcomes of Diabetic Macula Edema Patients Switched to Af... | NCT02000102

Studies
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab

NCT02000102

Sponsor

Stanford University

Status

Completed

Last Update Posted

Nov 18, 2014Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Diabetic Macular Edema

Interventions

Intravitreal Injection of Aflibercept

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Nov 26, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 18, 2014Estimated

Description Module

Brief Summary

Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic Macular Edema Patients Switched to Aflibercept			Drug: Intravitreal Injection of Aflibercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Injection of Aflibercept	Drug		Diabetic Macular Edema Patients Switched to Aflibercept

Measure	Description	Time Frame
Visual Acuity		1 year

Measure	Description	Time Frame
Central Subfield Thickness on Optical Coherence Tomography		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab -

Exclusion Criteria: None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Byers Eye Institute at Stanford		Palo Alto	California	94303	United States