Recruiting

Diabetic Macular Edema

Sponsor:

Elman Retina Group

Code:

NCT01934920

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Conditions

Diabetic Macular Edema

Study ID

NCT01934920

Start date

Aug, 2016

Status verified date

Feb, 2019

Completion date

May, 2019

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Assess the incidence of new and/or undiagnosed diabetic macular edema. [ Time Frame: 1 day (Patients are only seen once for assessments) ]

Central Contacts and Locations

Central contacts

Jennifer Belz

4106863000belz@elmanretina.com

Locations

Aaron Goldberg, Primary Care

Recruiting

Baltimore, Maryland, United States, 21209

Contacts

Jennifer Belz

410-686-3000belz@elmanretina.com

Principal Investigator:

Michael Elman, MD

MedStar Hospital

Recruiting

Baltimore, Maryland, United States, 21237

Principal Investigator:

Michael J Elman, MD

More Information

Sponsor

Elman Retina Group

Last update posted

Feb 7, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elman Retina Group on 2019-02-07.