DME FOUND: OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

• Sponsor: Joslin Diabetes Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01875783
• Collaborator: Genentech, Inc. (Industry), Juvenile Diabetes Research Foundation (Other), Optovue (Industry)
• Enrollment: 385
• Locations: 4
• Arm: 1
• Actual Duration (Months): 28
• Patients Per Site: 96.3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetic Macular Edema; Diabetic Retinopathy	Device: OCT imaging	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 385 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Care Provider, Investigator)
• Masking Description: Primary diabetes care specialists masked to results of OCT intervention
• Primary Purpose: Diagnostic
• Official Title: Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
• Actual Study Start Date: Mar 17, 2014
• Actual Primary Completion Date: May 14, 2015
• Actual Study Completion Date: Jul 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCT imaging All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.	Device: OCT imaging; Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.

Outcome Measures

Primary Outcome Measures

1. Rates of Retina Care Referral for Patients With Diabetic Macular Edema [Baseline visit]

   Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

Secondary Outcome Measures

1. Retinal Referral Rates for Patients With DME [Baseline visit]

   Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

2. Rates of Retinal Treatment for Patients With DME [One month]

   Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment

3. Rates of Retinal Treatment Over 1 Year for Patients With DME [9 months]

   Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus as evidenced by:

• Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR

• Documented diabetes by American Diabetes Association and/or World Health Organization criteria

• Age greater than or equal to 18 years old

• Diabetes duration of 10 more years OR last measured HbA1c of 10% or more

• Able and willing to participate in study procedures and comply with study follow-up visits

• Able to give informed consent for study participation

• Not moving out of the study area during the 1 year follow-up period

Exclusion Criteria:

• Unable to cooperate with the OCT image acquisition procedure or other study procedures

• Unable or unwilling to comply with the study follow-up visits

• Unable or unwilling to sign form for release of retinal medical records

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215
2	OuterCape Health Services, Inc	Wellfleet	Massachusetts	United States	02667
3	SUNY Upstate Medical University	Syracuse	New York	United States	13210
4	University of Endocrine Consultants	Chattanooga	Tennessee	United States	37411

Sponsors and Collaborators

• Joslin Diabetes Center
• Genentech, Inc.
• Juvenile Diabetes Research Foundation
• Optovue

Investigators

• Principal Investigator: Jennifer K Sun, MD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joslin Diabetes Center
• ClinicalTrials.gov Identifier: NCT01875783
• Other Study ID Numbers: 2011-17
• First Posted: Jun 12, 2013
• Last Update Posted: Dec 22, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Joslin Diabetes Center: diabetes; diabetic macular edema; diabetic retinopathy; optical coherence tomography
• Additional relevant MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus; Edema

Study Results

Participant Flow

Arm/Group Title	OCT Imaging
Arm/Group Description	All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Period Title: Overall Study
STARTED	385
COMPLETED	385
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OCT Imaging
Arm/Group Description	All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Overall Participants	385
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	294 76.4%
>=65 years	91 23.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.8 (14.1)
Sex: Female, Male (Count of Participants)
Female	193 50.1%
Male	192 49.9%
Region of Enrollment (Count of Participants)
United States	385 100%

Outcome Measures

1. Primary Outcome

Title	Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Description	Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Retina Specialist Care
Arm/Group Description	Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)
Measure Participants	385
Count of Participants [Participants]	44 11.4%

2. Secondary Outcome

Title	Retinal Referral Rates for Patients With DME
Description	Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eyes That Have Undergone OCT Imaging
Arm/Group Description	All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Measure Participants	385
Measure eyes	761
Count of Units [eyes]	59

3. Secondary Outcome

Title	Rates of Retinal Treatment for Patients With DME
Description	Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment
Time Frame	One month

Outcome Measure Data

Analysis Population Description

This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm

Arm/Group Title	Participants Referred for Retina Care
Arm/Group Description	Study participants identified for retina referral by the OCT guided referral algorithm.
Measure Participants	34
Count of Participants [Participants]	14 3.6%

4. Secondary Outcome

Title	Rates of Retinal Treatment Over 1 Year for Patients With DME
Description	Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm.

Arm/Group Title	Participants Referred for Retina Care
Arm/Group Description	Study participants identified for retina referral by the OCT guided referral algorithm.
Measure Participants	34
Count of Participants [Participants]	18 4.7%

Adverse Events

Arm/Group Title	OCT Imaging
Arm/Group Description	All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
All Cause Mortality
	OCT Imaging
	Affected / at Risk (%)	# Events
Total	0/385 (0%)
Serious Adverse Events
	OCT Imaging
	Affected / at Risk (%)	# Events
Total	0/385 (0%)
Other (Not Including Serious) Adverse Events
	OCT Imaging
	Affected / at Risk (%)	# Events
Total	0/385 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.