Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01934920
• Other study ID #: Elman-01
• Status: Recruiting
• Start date: August 2016
• Est. completion date: May 2019

Study information

• Verified date: February 2019
• Source: Elman Retina Group
• Contact: Jennifer Belz
• Phone: 4106863000
• Email: belz[@]elmanretina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
United States	Aaron Goldberg, Primary Care	Baltimore	Maryland
United States	MedStar Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Elman Retina Group	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Streamlining and identification of patients at risk of diabetic macular edema	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)