A weekly e-newsletter to help increase awareness and support patient education. This week features Szilárd Kiss, MD, discussing the diabetic risk factors and key conversations to have with patients. This week’s edition features Charles C. Wykoff, MD, PhD, discussing types of diabetes and shifting treatment options resulting from new data and studies. David Eichenbaum, MD, discussing the risk factors for diabetes and diabetic macular edema. Geeta Lalwani, MD; and A. Paul Chous, OD discussing DME compliance tips and pearls.

PART 1
COMING SOON:

Szilárd Kiss, MD

PART 2

Charles C. Wykoff, MD, PhD

PART 3

David Eichenbaum, MD

PART 4

Geeta Lalwani, MD; and A. Paul Chous, OD

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Diabetic VISION LOSS CONSEQUENCES - MAKING IT REAL

"How long have you had Diabetes?" An important question to ask your patients.

We know disease duration is the leading risk factor for vision loss from diabetes.1

  • It is critical to perform comprehensive dilated fundus examinations throughout a patient’s life, starting at diagnosis for patients with type 2 diabetes and within 3 to 5 years of diagnosis for those with type 1 diabetes.
  • Thereafter, these comprehensive examinations should be performed at least every 1 to 2 years, keeping in mind that these patients have an increased risk for glaucoma and cataracts in addition to diabetic retinopathy (DR). Diabetes can affect both central and peripheral vision, contrast sensitivity, and color vision, ultimately affecting every aspect of vision in daily life. While disease duration is an immutable fact, there are three systemic factors that patients can modify and control to minimize their risk of vision loss.

The Big 3 Modifiable Risks for Diabetic Vision Loss

Elevated levels of blood sugar, blood pressure, and blood lipids are all associated with disease progression and the onset of DR.1,2

  1. Hyperglycemia. Diabetes causes leaky blood vessels, resulting in part from high circulating sugar levels. The worse those daily sugar levels are, the worse the hemoglobin A1c is, and the more likely a patient will experience vision-threatening ocular changes.
  2. Hypertension. Uncontrolled high blood pressure increases the level of DR, similar to water squeezing out of a leaky hose as pressure increases.
  3. Hyperlipidemia. High blood lipids and blood cholesterol increase the risk of diabetic eye disease. They seep out of the leaky vessels and settle in and underneath the retina, ultimately resulting in vision loss.

Regular eye examinations along with good control of blood sugar, blood pressure, and blood lipids are the primary steps patients can take to minimize their risk of diabetic eye disease.

other risks to consider

1. Pregnancy. Pregnancy can cause changes to diabetic eye disease, almost independent of blood sugar levels. In the setting of abnormal blood sugars, the retinopathy can progress.3 Women with diabetes should be examined as the family planning process progresses, during the first and second trimesters of pregnancy, and after giving birth.

2. Sleep Apnea. Sleep apnea has been linked to worsening diabetic eye disease, owing to intermittent hypoxia,4 but eye care providers and primary care physicians often do not associate this condition with vision loss. If your patient is obese, has some difficulty breathing, and seems tired most of the time, ask about sleep apnea, particularly if his or her DR seems out of proportion to what you think it should be. Treating sleep apnea may help a patient’s diabetic eye disease.

3. Denial. Some patients, for many reasons, do not visit their doctors, even when they suspect something may be wrong. Educating patients on the risk factors associated with diabetes and the consequences of nonadherence is vital to preventing tragic results.

what’s the point? — diabetic vision loss is life-changing

Diabetes is an incurable disease; however, it can be controlled. It is important for eye care providers to counsel patients about lifestyle changes and medications that will help them control risk factors associated with diabetes.

We are all a part of the education solution to teach our patients about the risks associated with this disease. We also need to make the consequences of untreated diabetes tangible. Taking the time to bring the picture together for patients can make a big difference in how they interpret these consequences.

remember to tell your patients:

  1. Vision impacts every facet of your life.
  2. Taking the steps to manage your diabetes avoids vision loss and maintains your ability to do the things you love and to be independent.
  3. Vision loss is life-changing, and you can help prevent it from happening to you.

1. Jau JW, Rogers SL, Kawasaki R, et al.; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-564.

2. Yun JS, Lim TS, Cha SA, et al. Lipoprotein(a) predicts the development of diabetic retinopathy in people with type 2 diabetes mellitus. J Clin Lipidol. 2016;10:426-433.

3. Morrison JL, Hodgson LA, Lim LL, Al-Qureshi S. Diabetic retinopathy in pregnancy: a review. Clin Exp Ophthalmol. 2016;44:321-334.

4. Nashimura A, Kasai T, Tamura H, et al. Relationship between sleep disordered breathing and diabetic retinopathy: Analysis of 136 patients with diabetes. Diabetes Res Clin Pract. 2015;109:306-311.

Diabetic Retinopathy Update – Shifting Treatment Paradigms

Advances in pharmacotherapy signal a move toward earlier treatment.

Diabetic retinopathy (DR) is a blinding disease, but in a majority of cases today, it is treatable, and blindness can be prevented if patients are diligent about compliance (See last week’s article).

Positive outcomes over the last decade stem from advances in pharmacotherapy — both anti-VEGF agents and steroids — that built on the value of retinal lasers. New data and ongoing studies are expanding our indications. By initiating treatment earlier in the disease course, you can attempt to preserve vision, improve quality of life, and ultimately reduce the treatment burden for your patients.

Here is a snapshot of where we stand now, with a look at the most recent FDA approval and ongoing trials that may trigger future paradigm shifts.

Treating PDR and DME

The two most common causes of blindness in diabetes are proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME).

  1. PDR. All patients with PDR need treatment or, at the very least in rare instances, close monitoring, with treatment likely in the near future.
  2. DME. Most patients with DME will ultimately be treated, particularly those with center-involved macular edema with associated loss of visual acuity or associated symptoms if their visual acuity is good.
    • Patients who have DME but are asymptomatic, or symptomatic with excellent visual acuity, may be actively treated or not, but they need to be closely monitored. A large ongoing DRCR.net trial (Protocol V) is investigating these patients.

DR News

  1. United States. The FDA expanded the approved indications of ranibizumab (Lucentis, Genentech) to include treatment of all forms of DR, based on data from the Phase 3 DRCR.net Protocol S trial.1
  2. United Kingdom. Investigators for the smaller Phase 2 CLARITY trial studied the use of aflibercept (Eylea, Regeneron) in a similar PDR population and reported similar findings,2 adding further support to the efficacy of anti-VEGF therapy for PDR.

The data from these trials are shifting treatment patterns. Many cases of PDR are now managed with anti-VEGF therapy, often in combination with more limited peripheral laser application.

NPDR News

Optimal management of patients with nonproliferative diabetic retinopathy (NPDR) without DME, is in flux.

  1. Earlier Treatment Ongoing Trials. Two large randomized trials — PANORAMA sponsored by Regeneron and Protocol W sponsored by the DRCR.net — are currently underway, looking at treating these patients earlier than we traditionally would have. In both trials, patients with moderately severe NPDR, DR without DME, are receiving aflibercept or the clinical standard of care, observation.
  2. Targeting the NPDR “sweet spot.” There appears to be a “sweet spot” for patients with DR just before they progress to PDR.
    • Based on analyses such as the LA Latino Eye Study,3 we know this patient population, who are currently not being actively treated, have already experienced significant reductions in vision-associated quality of life, and, on average, they have decreased functional vision.
    • When we treat these patients with anti-VEGF therapy, many of them have significant and clinically relevant improvements in their DR severity levels.
    • If we can capture these patients before they develop PDR or DME, we may be able to turn back the clock by improving their DR severity level. This has the potential to improve their quality of life from a visual function perspective, and substantially decreasing the rate at which they develop PDR and DME.

Is Earlier Intervention the Key?

I believe we will find that the earlier we treat DR and DME, the fewer treatments patients will need and the better ultimate visual outcomes they will enjoy. I believe our treatment paradigms will continue to shift toward intervening earlier, giving our patients better long-term visual potential.

1. Beaulieu WT, Bressler NM, Melia M, et al.; Diabetic Retinopathy Clinical Research Network. Panretinal photocoagulation versus ranibizumab for proliferative diabetic retinopathy: patient-centered outcomes from a randomized clinical trial. Am J Ophthalmol. 2016;170:206-213.

2. Sivaprasad S, Prevost AT, Vasconcelos JC, et al.; CLARITY Study Group. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017;389:2193-2203.

3. McKean-Cowdin R, Varma R, Hays RD, et al.; Los Angeles Latino Eye Study Group. Longitudinal changes in visual acuity and health-related quality of life: the Los Angeles Latino Eye study. Ophthalmology. 2010;117:1900-1907.

Diabetes and DME: Common Risk Factors

The most common risk factors for type 2 diabetes include being older than 30 years of age, having a sedentary lifestyle, and having a body mass index of 25 to 29.9. In addition, having a family history of diabetes, having given birth to a baby who weighed more than 9 lbs, the presence of cardiac risk factors, including a history of hypertension and abnormal cholesterol levels, also increases a person’s risk for diabetes.1 While the risk for diabetes increases with age, younger patients who are obese and have a strong family history of diabetes are at increased risk of type 2 diabetes as well. Ethnicity can also play a role. Certain ethnic groups are at higher risk, including Native Americans, African-Americans, Latinos, Pacific Islanders, and Asians.

Anyone older than 45 years should have a screening test for diabetes, with repeat screening every 3 years. Those with risk factors, specifically those who are overweight and have a positive family history of diabetes, should be screened at a younger age. There is no standard for how young screening should begin, but in my practice, I have seen 10-year-olds with type 2 diabetes. A fasting blood test will determine your fasting blood sugar. According to the American Diabetes Association, results higher than 100 mg/dL indicate prediabetes and higher than 125 mg/dL is diabetes.2

Once a patient is diagnosed with prediabetes, it is important for he or she to increase moderate intensity physical activity (such as brisk walking) to at least 150 minutes a week and to lose weight. The weight loss does not need to be dramatic, because losing 7% of your body weight, which is about 10 to 15 pounds for most people, can decrease the risk of developing diabetes.1 Advise patients that the goal of exercise and weight loss is not about looking thin, it is about losing enough weight to improve their body's ability to use insulin and process glucose and help the body’s insulin-producing cells, the beta cells, function better. The research shows that it can be very helpful.2

If diet and exercise are not effective, a medication called metformin, which is indicated for type 2 diabetes, can halt the progression from prediabetes to diabetes.3 It is an off-label use, but many physicians are prescribing metformin to prevent the development of diabetes.3 It is really important that patients know if they have prediabetes, because it is better to prevent it than to treat it.4 Patients can utilize in-person and online Diabetes Prevention Programs offered by the CDC.

For those who have diabetes, the risk for developing diabetic retinopathy and diabetic macular edema depends on two factors: duration of diabetes and the level of glucose control. If a person has had diabetes since childhood, he or she is likely going to have some form of diabetic retinopathy by age 80 years. However, having mild retinopathy may not impact visual acuity and effective treatments are available for more serious forms of eye disease. This is why regular eye examinations are so important—it is possible to have 20/20 visual acuity but still have damage in the back of the eye. Ophthalmologists have the tools to detect and treat, if needed, the ocular complications of diabetes to help maintain vision.

1. American Diabetes Association. Diagnosing Diabetes and Learning About Prediabetes. diabetes.org. www.diabetes.org/are-you-at-risk/prediabetes/?loc=atrisk-slabnav. Last Edited June 9, 2015. Accessed October 5, 2016.

2. Knowler WC, Fowler SE, Hamman RF, et al; Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677–1686.

3. Bray GA, Edelstein SL, Crandall JP, et al; Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care. 2012;35(4):731–737

4. Overview of the Diabetes Prevention Program (DPP), National Institute of Diabetes and Digestive and Kidney Disease. niddk.nih.gov. www.niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp/Pages/default.aspx. Accessed on September 27, 2016.

Diabetic Macular Edema: Compliance Tips and Pearl

I encourage patients with diabetes to comply with therapy by emphasizing the positive points and educating them about the negative. That is, they can lose vision unless they have regular examinations and follow the recommended protocol for disease management. I believe that showing patients their optical coherence tomography images so they can track the reduction of their diabetic macular edema helps patients to understand why treatment is important. It encourages them to be more engaged in how the therapy is affecting their potential for best vision and, therefore, helps them comply with the therapy.

Regular eye examinations are important because diabetic retinopathy is still the No. 1 cause of blindness among working-age Americans.1 Patients with diabetes mellitus may be unaware that they have vision-threatening disease, because it does not always cause pain and/or redness in the eyes. It is the responsibility of the physician to emphasize the importance of visual screenings to their patients. Family practitioners are graded on whether their diabetic patients are having regular eye screenings. Public education campaigns are very important as well. They are designed to work in conjunction with physicians to inform patients about their risk of vision loss as a complication of diabetes.

As a retina specialist, I focus on vision and the anatomy that we see with optical coherence tomography. However, to provide the best possible care for a patient with diabetic macular edema, I think it is important to step into the shoes of the patient who is experiencing vision loss. These are patients who often are being affected in a variety of ways. Perhaps their hands and feet are starting to go numb. Maybe the doctor is telling them that their kidneys are not working properly. They may not be getting regular exercise that is beneficial to control their blood sugar and blood pressure and help them have a sense of well-being.

These patients need encouragement. Encourage them to monitor their A1C levels and to walk 30 minutes a day. If they cannot walk 30 minutes a day, then tell them to start with 10 minutes a day. They should be mindful about what they are eating and drinking, because their diet affects how they feel, their blood sugar, and their vision. If they comply, they not only regain a sense of control, but they may also improve their vision.

1. Sieving PA. Sharp rise in diabetic eye disease makes american diabetes month ever more important. Nie.nih.gov. https://nei.nih.gov/news/statements/diabetesmonth2012. Accessed October 5, 2016.

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About Retina Today

Retina Today is a publication that delivers the latest research and clinical developments from areas such as medical retina, retinal surgery, vitreous, diabetes, retinal imaging, posterior segment oncology and ocular trauma. Each issue provides insight from well-respected specialists on cutting-edge therapies and surgical techniques that are currently in use and on the horizon.