NCT02933905

Brief Summary

Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 12, 2016

Last Update Submit

October 14, 2016

Conditions

Diabetic Macular EdemaVitreomacular InterfaceAnti-VEGF Treatment

Outcome Measures

Primary Outcomes (1)

  • Change in best-corrected visual acuity

    One year

Secondary Outcomes (2)

  • Change in central macular thickness

    One year

  • Number of ranibizumab injections

    One year

Study Arms (2)

Non-PVD subjects

Patients with no PVD on SD-OCT at basal visit

Drug: Intravitreal Ranibizumab injection

PVD subjects

Patients with PVD on SD-OCT at basal visit

Drug: Intravitreal Ranibizumab injection

Interventions

Intravitreal Ranibizumab injectionDRUG
Non-PVD subjectsPVD subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diabetic macular edema

You may qualify if:

  • diabetic macular edema treatable with antiangiogenic drugs

You may not qualify if:

  • age under 18
  • cardiovascular events during the last year
  • previous vitrectomy
  • previous macular edema treatment during the last 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FEBO

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10