Imaging Parameters and DME Treatment Response

NCT02637245 | Completed

• 1 other identifier: Pro00061249
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients. While anti-VEGF treatments and to a lesser extent corticosteroid and macular photocoagulation have improved outcomes in patients with DME, no single therapy is universally effective and currently there is no a priori means of determine which patients will respond best to any given therapy. The purpose of this study is to determine whether specific parameters of ocular imaging studies including optical coherence tomography and fluorescein angiography can predict response to treatment in patients with DME. This is a prospective observational cohort study that will collect clinical data and imaging studies obtained as standard of care. Up to 150 subjects with clinically significant DME will be enrolled at Duke Eye Center or its satellite offices. These imaging studies will be analyzed to determine whether specific parameters are associated with poor or favorable response to specific treatments. There will be no intervention as part of this observational trial, thus the primary risk to subjects is loss of confidentiality, which will be minimized by the study team.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Keywords

diabetic macular edema; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Changes in disease state characteristics in response to therapy

  Generated software will be used to analyze FA and OCT images at the start, duration and end of the study. We have developed automated segmentation software for both optical coherence tomography (OCT) and fluorescein angiography (FA). This software will be used to quantify specific imaging parameters including leakage area, diffuse leakage, focal leakage from FA and cyst volume, cyst location, inner retinal volume and outer retinal volume from OCT.

  Six months post treatment

Secondary Outcomes (1)

• Changes in visual acuity using ETDRS visual acuity assessment

  Baseline, Six months post treatment

Study Arms (1)

Patients with Diabetic Macular Edema

Patients with Diabetic Macular Edema. There will be no intervention in this cohort, only observation of standard of care.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with Diabetic Macular Edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of DME in one or both eyes which is visually significant in the opinion of the clinician/investigator.

You may qualify if:

• Able to provide written informed consent
• Diagnosis of DME in one or both eyes which is visually significant in the opinion of the clinician.

You may not qualify if:

• Macular edema secondary to causes other than diabetes
• Known or suspected sensitivity or allergy to fluorescein dye
• Significant media opacity (e.g. cataract or vitreous hemorrhage)
• Prior history of vetrectomy surgery

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Michael Allingham, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 22, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 5, 2025

Record last verified: 2025-09

Locations

US (1)