The Latest on Eylea: A Leading Treatment for Diabetes-Related Retinopathy

27 Apr 2021 diabetic retinopathy, eye health, eylea, News, Partners, retinopathy, Treatments, Trial, Type 1 Diabetes, Type 2 Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Kira Wang

New results on Eylea, a treatment for diabetes-related retinopathy, show that the therapy reduces the risk of more serious eye complications when used for prevention.

Key findings were recently published on Eylea, a common therapy in the US used to treat several eye conditions including diabetes-related eye disease. According to Dr. Jennifer Sun (co-chair of the Diabetic Retinopathy Clinical Research Network), 60% of patients may not know they have some form of early-stage diabetes-related retinopathy which may not affect one’s ability to see. The clinical trial was focused on prevention: does early Eylea treatment of diabetes-related retinopathy result in better vision later on? The answer may not yet be clear – while Eylea was found to reduce specific vision-threatening complications, it did not meaningfully improve vision outcomes in the published study.

Eylea is an approved treatment for diabetes-related macular edema and diabetes-related retinopathy, two of the eye complications associated with diabetes. Eylea is an anti-VEGF therapy, meaning that the drug blocks VEGF, a protein that is necessary for new blood vessel growth. The medication is injected into the eye by an ophthalmologist every four to 16 weeks, depending on the severity of the eye disease.

The trial looked at 328 adults with early-stage diabetes-related retinopathy (also called non-proliferative diabetes-related retinopathy) and excellent vision. At the beginning of the study, about half of the eyes received Eylea injections every 16 weeks, and the other half received a placebo injection (which included no medication). The preliminary data were reported through two years. The study will continue for a total of four years.

The researchers were studying two main outcomes in these eyes:

  • Changes in the anatomy of the retina (for evidence of either a more advanced stage of diabetes-related retinopathy, called proliferative diabetes-related retinopathy, or the development of swelling called center-involved diabetes-related macular edema). These can be thought of as structural changes in the eye.
  • A functional difference in participants’ ability to see, known as their visual acuity. See below for key findings after two-years:

The trial found that Eylea led to improved anatomical outcomes and reduced the risk of more serious eye complications:

  • Eylea reduced the risk of developing complications by 68% when compared to the placebo. The probability of developing any complication was 16% in the Eylea group and 44% in the placebo group.
  • Individually, participants taking Eylea were 66% less likely to develop more advanced stages of diabetes-related retinopathy (proliferative diabetes-related retinopathy) and 64% less likely to develop macular edema with vision loss.
  • People receiving placebo injections were five times more likely to need additional treatment (with Eylea) with worsening of the eye disease.
  • There was no difference in the vision quality of either group after two years (excellent vision in 75% of the treatment group and 72% of the placebo group).

The four-year results of the trial will be important in determining whether the higher rate of complications in the placebo group might eventually lead to more vision loss in that group. If this is the case, treating diabetes-retinopathy in its earliest stages with Eylea may present a long-term benefit for vision.

There are several treatment options for diabetes-related eye disease, including oral medications, laser treatments for the eyes, and therapies like Eylea. Increasingly, surgical techniques are being used for less advanced stages of diabetes-related eye disease. Other novel strategies are also being investigated to avoid needing regular injections into the eye.

More information is needed before Eylea can be considered for use as a widespread tool to prevent worsening of diabetes-related retinopathy. Dr. Sun’s bottom line for clinicians and patients? “With regular follow-up and rigorous evaluation, the chances of continuing to have good vision, even with severe non-proliferative diabetic retinopathy and moderate non-proliferative diabetic retinopathy, are excellent. I don’t think this study says that early treatment should be routinely given yet. It is important to hang tight and wait for four-year results.”

The most important action people with diabetes can take is to have an annual dilated eye exam, in addition to managing glucose, blood pressure, and cholesterol levels. If diabetes-related eye disease worsens, there a number of options that can be used to prevent vision loss. To learn more about protecting your eyes and treating eye disease, check out our series: Caring For Your Eyes.

Source: diabetesdaily.com

Person with Type 1 Diabetes in the Moderna COVID-19 Vaccine Trial

7 Jan 2021 COVID-19, insulin, Intensive management, Partners, Trial, Type 1 Diabetes, U.S. Food & Drug Administration (FDA), vaccination

This content originally appeared on Beyond Type 1. Republished with permission.

By Zoe Cook

Here’s the quick version for all of those who don’t have time to read my full experience below — I trialed the Moderna COVID-19 vaccine and *spoiler alert* had a great experience.

If you had asked me ten months ago where I thought life would be now, it would be anywhere but here. I was preparing to graduate from UT Austin, finalizing my application to medical school, and planning my gap year. I had planned to spend the year traveling, working as an EMT, and living life to the fullest before I commit myself to my career for good. It was only a few weeks after the news first broke of COVID-19 that I was emailing my professors and voluntarily studying from home. Quickly realizing that our entire family is high-risk, we decided to air on the side of caution. The first week of March we decided to lock down and we’ve barely left since.

Why I Participated

In early August, I found out that a local research center was conducting a trial for the Moderna COVID-19 vaccine and that they were looking for high-risk frontline workers to participate (at the time, I was working at a children’s hospital). Many people questioned my choice to participate, but here’s why I decided it was right for me:

  1. My entire family is high-risk and not only was I the only one leaving the house, but I was leaving to work at a hospital.
  2. Thanks to my pre-med studies, I understand mRNA technology and the FDA clinical trial safety measures enough to feel comfortable in making an educated decision.
  3. I participated in the blinded Teplizumab trial when I was first diagnosed at the age of ten, so I am no stranger to the clinical trial process.
  4. I wanted to be a part of the solution. My nature is to help others in any way that I can; someone has to trial it for other type 1s, why not me?

Sure, my hands were shaking and I was sweating as I signed the final consent form, but it was something I felt I just needed to do.

The Doses

I went in for my first dose in mid-August. It was a long first appointment filled with lots of signatures, tests, and questions. I received my first dose that same day, with a 50/50 chance that I had the vaccine or placebo. The next day I had some arm soreness, but nothing else. I was secretly hoping for at least a little chill or body ache to try and confirm that I received the vaccine, but nothing. I was disappointed with the uncertainty, but also knew that symptoms were expected to be worse after the second dose and that I had a slightly swollen lymph node in my neck. A month later in mid-September, I had a second dose, which again resulted in no immediate side effects and didn’t even make the lymph node swell up again. Interestingly, after both doses, my insulin needs dropped slightly over four days, with the fourth day needing ~30% less insulin. I also developed eczema on my face, which is something I likely would have developed at some point in my life since we have a family history of many skin issues.

In October, I got my antibodies tested and was surprised to find out that I did indeed have antibodies. I can’t say for sure yet whether I had the vaccine, but based on the lymph nodes, sore arm, and antibody tests, it seems fairly certain. As I’m isolated and no one I know has had COVID symptoms, it would be highly unlikely that I got antibodies from anywhere else.

Editor’s Note: According to interim guidance from the CDC, COVID-19 antibody tests are not 100% accurate can result in both false negatives and false positives.

Even though I have antibodies and could assume I had the vaccine, I didn’t know how truly effective the vaccine was. I decided to still treat myself as though I was unvaccinated and not take any chances. Now that it’s been announced that the vaccine is 95% effective, I can feel more comfortable returning back to some form of normal-ish life. Even then, it’s been hard to undo the anxiety and fear that seem to have become a part of daily life over the past ten months. I still get uncomfortable when I see someone without a mask, don’t even begin to consider large gatherings, and stay home as much as possible. The changes for me have been small — being able to go to the grocery store, have a cup of coffee with a close friend, and start looking for jobs again. For our family, it was just the simplicity of going to bed with peace of mind that is priceless.

What’s Next

Within the next few days, trial participants should find out about the process of being unblinded if we are offered a vaccine elsewhere. I will most likely choose to stay blinded to keep the study valid. As long as I continue to test positive for antibodies, I personally don’t feel a need to be officially unblinded, as I imagine this means we will have to be removed from the trial.

For privacy reasons, I won’t say which trial center I participated with, but I can say that they were amazing. The staff and study coordinators made the expectations of me as a participant crystal clear and were responsive to any (and all) questions and concerns. I am very grateful that I had the opportunity to receive a vaccine early on and that I was able to potentially help others in the process. I cannot thank Moderna, their scientists, or their research teams enough for the peace of mind and protection they have provided both me and my family.

Originally I thought 2020 was going to be my year — the year I graduated, did an IronMan, traveled, lived life, worked hard, and visited my dream medical schools. Now, 2020 has been the year that reminded me to be grateful for all of the things I already had. I still got to wear a cap and gown, even if it was at home. I found a different way to work, a different way to interview at schools, and planned my own triathlon. Life being “paused” has reminded me how precious quality time with family is, the enjoyment of a good book, and how easy it is to take things for granted.

Source: diabetesdaily.com

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