Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

NCT ID: NCT01934920

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elman Retina Group

OTHER

Sponsor Role lead

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Elman, MD

Role: PRINCIPAL_INVESTIGATOR

Elman Retina Group, P.A.

Locations

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Aaron Goldberg, Primary Care

Baltimore, Maryland, United States

Site Status RECRUITING

MedStar Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Belz

Role: CONTACT

4106863000

Facility Contacts

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Jennifer Belz

Role: primary

410-686-3000

Other Identifiers

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Elman-01

Identifier Type: -

Identifier Source: org_study_id

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