Imaging Parameters and DME Treatment Response
Completed
Conditions studied: Diabetic Macular Edema, Diabetic Retinopathy
In brief
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.
Key facts
- Study ID
- NCT02637245
- Run by
- Duke University
- People needed
- 32
- Starts
- 2015-05-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Duke Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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