Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02637245 |
| Other study ID # |
Pro00061249 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
March 2023 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
