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NCT02637245 · ClinicalTrials.gov registry record
Imaging Parameters and DME Treatment Response
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 32
- Enrollment target
NCT02637245: Completed study, sponsored by Duke University.
NCT02637245 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637245 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-12 |
What the finished NCT02637245 record still lists
NCT02637245 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT02637245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02637245 about?
NCT02637245 is a clinical study titled "Imaging Parameters and DME Treatment Response". 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...
What is the current status of trial NCT02637245?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2015-05. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02637245?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT02637245?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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