Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

February 6, 2019 updated by: Elman Retina Group
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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Aaron Goldberg, Primary Care
        • Contact:
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Hospital
        • Principal Investigator:
          • Michael J Elman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the incidence of new and/or undiagnosed diabetic macular edema.
Time Frame: 1 day (Patients are only seen once for assessments)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streamlining and identification of patients at risk of diabetic macular edema
Time Frame: 1 day (Patients only seen once for assessments)

Establish methods for streamlining screening and identification of patients at risk.

Establish methods for referral for treatment of patients identified with vision threatening diabetic retinopathy.
1 day (Patients only seen once for assessments)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elman Retina Group

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Michael J Elman, MD, Elman Retina Group, P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 3, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elman-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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