CLINICAL TRIAL

Optical coherence tomography angiography for Diabetic Retinopathy

Recruiting · 18+ · All Sexes · Vancouver, Canada

This study is evaluating whether there are differences in the micro-vascular changes in patients with diabetes.

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About the trial for Diabetic Retinopathy

Eligible Conditions
Diabetes Mellitus · Diabetic Retinopathy · Retinal Diseases

Treatment Groups

This trial involves 2 different treatments. Optical Coherence Tomography Angiography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Optical coherence tomography angiography
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optical coherence tomography angiography
2017
N/A
~300

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age ≥18 Participants can have 1 or 2 study eyes
Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 18 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 18 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Optical coherence tomography angiography will improve 1 primary outcome and 5 secondary outcomes in patients with Diabetic Retinopathy. Measurement will happen over the course of 6 months.

Retinal layer thickness
6 MONTHS
Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
Presence of predominantly peripheral lesions (PPL)
6 MONTHS
The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
Perfusion density
6 MONTHS
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Foveal avascular zone (FAZ)
6 MONTHS
The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Areas of different perfusion density
6 MONTHS
Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
18 MONTHS
Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,

Who is running the study

Principal Investigator
E. N.
Eduardo Navajas, Principal Investigator
University of British Columbia

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is diabetic retinopathy?

DME is an important clinical aspect of the diabetic eye. Current knowledge and understanding of its significance will enable clinicians to initiate appropriate treatment during the pre-proliferative stage of the disease.

Anonymous Patient Answer

Can diabetic retinopathy be cured?

Recent findings of this study suggest that the primary treatment of diabetic retinopathy may be to minimize the severity of diabetic retinopathy and thereby the potential for visual loss, rather than to prevent or cure the retinal disease.

Anonymous Patient Answer

What are the signs of diabetic retinopathy?

Some signs of diabetic retinopathy include the presence on examination of a cotton wool spot, microaneurysms and a fragile neurosensory retina. In combination with visual field examination, diabetic retinopathy may be identified as early signs of diabetic retinopathy.

Anonymous Patient Answer

What are common treatments for diabetic retinopathy?

Diabetic retinopathy may not be treatable, but may be possible to prevent by keeping blood sugars below or at target levels. Retinal laser treatment and vitrectomy may improve vision outcomes in chronic diabetic retinopathy.

Anonymous Patient Answer

What causes diabetic retinopathy?

The main risk factors are old age and male sex. The presence of more than 20 NPDR or PDR (stage 4 diabetic retinopathy) increases the risk by more than a factor of ten. Other risk factors include refractive error, microvascular complications, and smoking. In patients with diabetic macular edema, the main risk factors are increasing severity of the macular edema and increasing duration of diabetes. In patients with proliferative retinopathy the risk is higher in patients with proliferative retinopathy, especially in those with a previous history of proliferative retinopathy of any stage. Diabetic patients at high risk of diabetic retinopathy may be identified by routine retinal examination.

Anonymous Patient Answer

How many people get diabetic retinopathy a year in the United States?

This survey indicates that in 2000, only about one-quarter of Americans had retinopathy. The disease affects younger individuals and those with poor glycemic control and obesity. However, the annual incidence of all retinopathy cases has increased.

Anonymous Patient Answer

What are the latest developments in optical coherence tomography angiography for therapeutic use?

Optical coherence tomography angiography detects the vessel wall changes in eyes that are at high risk for new bleeding, even in cases in which anti-VEGF therapy has failed and has therefore an important role as a therapeutic option for treating the neovascularisation-driven retinopathy in diabetic macular Edema and the subfoveal hemorrhage in diabetic retinopathy.

Anonymous Patient Answer

Does diabetic retinopathy run in families?

Genetic studies have shown that diabetic retinopathy runs in families, but we have not yet established any specific type of retinopathy. We found that FH(IIbE)/IH(I) and FH-I/IH(I) were associated with disease in the family history. The reason for the inheritance in FH-I/IH(I) is unknown.

Anonymous Patient Answer

What is the latest research for diabetic retinopathy?

In a recent study, findings of the latest prospective, randomized and controlled clinical researches were reviewed and analyzed. It is essential to maintain a good control of the blood sugar level, blood pressure and the blood lipids. It is difficult to modify them in order to avoid diabetic retinopathy. However, there are many ways to prevent the development of diabetic retinopathy. The following are the ways to prevent diabetic retinopathy, as reported in the latest scientific journals:\n\n1. Dental braces can help to keep the teeth in line with the bones, in turn assisting blood flow to the eyes.\n\n2.

Anonymous Patient Answer

How does optical coherence tomography angiography work?

OCTA clearly identified abnormal retinal capillaries in the majority of DR patients. OCTA appears to be a useful tool for assessing retinas at high risk for advanced DR.

Anonymous Patient Answer

Is optical coherence tomography angiography safe for people?

OCTA is a safe and reproducible technique for imaging retinal and choroidal vessel patterns. OCTA is feasible and safe in patients with severe macular edema, age over 75, and in diabetic individuals, which is important given that these patients may have abnormal retinal or choroidal vessel patterns. OCTA can be performed without the assistance of fluorescein angiography. OCTA imaging is an acceptable diagnostic alternative for macular edema in patients with contraindications for OCT, where the absence of fluorescein angiography leads to a higher likelihood of false-positive findings. OCTA is a useful adjunct in the diagnosis of macular edema.

Anonymous Patient Answer

Is optical coherence tomography angiography typically used in combination with any other treatments?

In patients with type 2 diabetes treated appropriately, there were no statistically significant differences in macular and retinal vessel vessel diameter when comparing diabetic patients with and without retinopathy. Optical coherence tomography angiography is most commonly used in combination with other retinal and macular procedures in diabetic patients. Results from a recent clinical trial in patients with type 2 diabetes are in line with results of previous studies.

Anonymous Patient Answer
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