NCT01934920

Brief Summary

This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

August 30, 2013

Last Update Submit

February 6, 2019

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Assess the incidence of new and/or undiagnosed diabetic macular edema.

    This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography

    1 day (Patients are only seen once for assessments)

Secondary Outcomes (1)

  • Streamlining and identification of patients at risk of diabetic macular edema

    1 day (Patients only seen once for assessments)

Eligibility Criteria

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

Patients identified through medical records or admitted into Franklin Square Hospital with a history of diabetes

You may qualify if:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 18 years
  • Patient related considerations
  • Patients with diabetes mellitus
  • Disease related considerations
  • Diabetes mellitus

You may not qualify if:

  • Prior admission screening within twelve months.
  • Inability to sit for evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aaron Goldberg, Primary Care

Baltimore, Maryland, 21209, United States

RECRUITING

MedStar Hospital

Baltimore, Maryland, 21237, United States

RECRUITING

Study Officials

  • Michael J Elman, MD

    Elman Retina Group, P.A.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Belz

CONTACT

4106863000belz@elmanretina.com

Study Design

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

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 4, 2013

Study Start

August 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

US(2)