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Diabetic Macular EdemaNCT02637245

Imaging Parameters and DME Treatment Response

An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema, Diabetic Retinopathy
How many people
32 participants
Where
1 siteUnited States
Study dates
May 2015to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Eye Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Imaging Parameters Predicting Treatment Response in Patients With Diabetic Macular Edema

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.

Read the detailed description

The investigators hypothesize that DME is a common endpoint caused by differing pathobiology which varies between patients. Clinically fluorescein angiography (FA) and optical coherence tomography (OCT) are used to diagnose and assess diabetic retinopathy including DME. These two imaging modalities provide different biological information with FA giving functional data regarding the perfusion and integrity of the retinal water homeostasis system where OCT gives structural information including the quantity and location of fluid in patients with DME. The investigators believe that careful analysis of both the leakage pattern on FA and the characteristics of intraretinal fluid on OCT have potential to provide insight into the predominant mechanism of DME in an individual patient. Specifically, it has been proposed that at least two forms of DME exist, focal and diffuse. In focal DME, leakage seen on FA originates predominantly from leaking microaneurysms present in the retinal microvasculature, which are markers for endothelial dysfunction and focal breakdown of the blood retinal barrier. Similarly, it has been hypothesized that focal leakage imaged by OCT will result in accumulation of noncystic fluid in the extracellular space. In contrast, diffuse pattern leakage has no discernable source on FA and it is believed that this pattern represents failure of the Müller and RPE cell pump function resulting in accumulation of intracellular fluid in the retina. Diffuse leakage imaged with OCT may appear as cystic fluid accumulation which represents swollen Müller or other retinal cells.

In clinical practice, most patients with DME have a mixture of focal and diffuse leakage with one type being predominant. The investigators hypothesize that, because they are driven by disparate pathobiology, different DME subtypes will respond differently to treatment. Thus, it may be possible to use fluorescein angiography and/or optical coherence tomography to predict the optimal treatment for an individual patient, thereby improving patient outcomes and possibly reducing treatment burden. To date, there are no prospective studies correlating FA and OCT imaging parameters with response to specific therapies, nor is there prospective data on using imaging parameters to guide choice of treatment modality in subjects with DME. As a first step toward determining whether imaging parameters predict treatment response, the investigators will prospectively collect imaging, treatment and outcome data in patients with diabetic macular edema treated at Duke Eye Center.

Being tested
No intervention
Keywords
diabetic macular edema, diabetic retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT02637245
Study groupRoleWhat they receive
Patients with Diabetic Macular EdemaPatients with Diabetic Macular Edema. There will be no intervention in this cohort, only observation of standard of care.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Six months post treatment

Secondary outcomes (1)
  1. Changes in visual acuity using ETDRS visual acuity assessment

    Visual acuity will be assessed using ETDRS visual acuity charts.

    Measured: Baseline, Six months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02637245
Sponsor's protocol ID
Pro00061249
Status last verified
Sep 2025
First submitted
10 Dec 2015
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema and Diabetic Retinopathy, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in disease state characteristics in response to therapy (time frame: Six months post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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