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.
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.
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.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- 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 group | Role | What they receive |
|---|---|---|
| Patients with Diabetic Macular Edema | Patients 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.
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)
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.
- First posted22 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Allingham, MD, PhD, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Parameters Predicting Treatment Response in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02637245
- Acronym / sponsor ID
- Pro00061249
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- diabetic macular edema, diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Diabetic Macular Edema | – | Other: No interventionPatients with Diabetic Macular Edema. There will be no intervention in this cohort, only observation of standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Able to provide written informed consent
- Diagnosis of DME in one or both eyes which is visually significant in the opinion of the clinician.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with Diabetic Macular Edema |
Primary outcome
Changes in disease state characteristics in response to therapy
Time frame: Six months post treatment
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.
1 secondary outcome
Changes in visual acuity using ETDRS visual acuity assessment
Time frame: Baseline, Six months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Related trials for Diabetic Macular Edema
Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Allingham, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.