Join Clinical Trials for Diabetic Eye Disease
Diabetic Eye Disease (Diabetic Retinopathy)
Diabetic eye disease is a serious side effect of diabetes that can lead to the complete loss of vision if not prevented and/or effectively treated. It results when blood vessels within the eye are damaged by excessive amounts of blood sugar. This damage impairs blood flow to the retinas of the eye, and in severe cases, can even block the flow of blood completely.
Vision impairment (including blurred vision) and even total vision loss can occur as a result. Unfortunately, diabetic eye disease does not always produce symptoms until it is too late. As the condition worsens, symptoms may include the presence of spots or “floaters” in the line of sight, blurred vision, vision fluctuations, dark areas within the visual field, complete vision loss, and difficulty perceiving colors. Regardless of the symptoms that are present, both eyes are usually affected.
Diabetic eye disease is generally classified into one of two types: early diabetic retinopathy and advanced diabetic retinopathy. By definition, the advanced form is the most severe type and incurs the greatest risk of complications.
Examples of complications stemming from diabetic eye disease include eye hemorrhage, retinal detachment (when the retina becomes detached from the back of the eye), glaucoma, and blindness.
Although anyone with a diagnosis of diabetes is at risk for developing diabetic eye disease, the risk is greatest among those who have had diabetes for a long period of time, those who have poorly-controlled blood sugar, individuals with high blood pressure and/or high cholesterol, pregnant women, and individuals who use tobacco products.
Current research efforts are focused on improved methods of screening for diabetic eye disease, investigating new and better means of treating diabetes-related eye damage, and discovering lifestyle and genetic factors that increase the risk of diabetic eye disease.
What Will A Diabetic Eye Disease Clinical Trials Be Like?
The types of tests and assessments used in diabetic eye disease clinical trials will ultimately depend on the specific nature of the study and what aspects of diabetic eye disease are being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials:
- Physical exam
- Dilated eye exam (during which the pupils are dilated using special eye drops, which enables the doctor to view larger areas inside the eye)
- Eye pressure test to measure for glaucoma
- Retinal photography
- Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
- Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
- Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
- Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
- Blood tests to monitor cholesterol
- Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
- Dietary and/or exercise interventions
- Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.
Typical Diabetic Eye Disease Clinical Trial Protocol:
Specific examples of clinical trials for diabetic eye disease might include the following:
- A randomized study to determine if injection of a new drug designed to stimulate repair of damaged eye tissue is effective at improving the outcome of standard eye surgery used to treat severe diabetic retinopathy. In such a study, patients would be randomly assigned to receive the injection plus standard surgery, or standard surgery alone.
- An observational study in which 100 individuals with various forms of diabetic retinopathy provide blood samples for analysis to determine if they have any specific genetic changes that might be associated with an increased risk of diabetic retinopathy. In addition, 100 individuals with diabetes but who do not have evidence of diabetic eye disease, as well as 100 healthy control subjects, would also be included in this study and would provide blood samples for analysis and comparison.
- An clinical trial in which individuals with mild to moderate diabetic retinopathy are randomly assigned to receive either standard care plus a nutritional supplement designed to improve visual functioning, or standard care plus a placebo.
- A study designed to evaluate the safety and effectiveness of a new laser eye therapy designed to slow the progression of diabetic retinopathy.
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment (such as the first example listed above).
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the third example listed above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors, including your specific type of diabetic eye disease, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:
- Your particular diagnosis of diabetic eye disease
- Your family history of diabetes
- Your prior history of treatment for diabetes and other medical conditions (including any surgeries, procedures, and medications)
- Your current medications (including aspirin), vitamins, and dietary supplements
- Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known)
Suggested Search Terms:
Once you are ready to begin your search for diabetic eye disease clinical trials, it is advisable to search using the term “diabetic retinopathy” plus any of the following keywords that may be relevant to your particular situation: “treatment,” “risk,” “prevention,” “screening,” “management,” “childhood,” “pediatric,” “vitamins,” “nutrition,” “surgery,” and “laser.”
Current Search Term:
“Diabetic Eye Disease”
Condition: Diabetic Retinopathy
Interventions: Drug: BI 1467335; Drug: Placebo
Sponsor: Boehringer Ingelheim
Conditions: Diabetic Retinopathy; Diabetic Eye Problems; Diabetic Macular Edema
Interventions: Procedure: Color fundus photography; Drug: Mydriatic Agent
Sponsors: Eyenuk, Inc.; National Eye Institute (NEI)
Enrolling by invitation