NCT02000102

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 26, 2013

Last Update Submit

November 17, 2014

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    1 year

Secondary Outcomes (1)

  • Central Subfield Thickness on Optical Coherence Tomography

    1 year

Study Arms (1)

Diabetic Macular Edema Patients Switched to Aflibercept

Drug: Intravitreal Injection of Aflibercept

Interventions

Intravitreal Injection of AfliberceptDRUG
Diabetic Macular Edema Patients Switched to Aflibercept

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Study Design

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

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

US(1)