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Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Sponsor
Elman Retina Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT01934920
Collaborator
Genentech, Inc. (Industry)
500
Enrollment
2
Locations
33
Anticipated Duration (Months)
250
Patients Per Site
7.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Identifying Patients With Unrecognized Treatable Diabetic Macular Edema
    Actual Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    May 1, 2019
    Anticipated Study Completion Date :
    May 1, 2019

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Streamlining and identification of patients at risk of diabetic macular edema [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aaron Goldberg, Primary Care Baltimore Maryland United States 21209
    2 MedStar Hospital Baltimore Maryland United States 21237

    Sponsors and Collaborators

    • Elman Retina Group
    • Genentech, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elman Retina Group
    ClinicalTrials.gov Identifier:
    NCT01934920
    Other Study ID Numbers:
    • Elman-01
    First Posted:
    Sep 4, 2013
    Last Update Posted:
    Feb 7, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Feb 7, 2019