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AMD, RVO, & DME Update: Case Studies in Patient & Practice Management

By: Jonathan L. Prenner, MD, Moderator; Dean Eliott, MD; Carl Regillo, MD; and Chirag P. Shah, MD, MPH

This course has expired. You can still review the content but course credit is no longer available.

Supplement Credits: 1

This continuing medical education (CME) activity is based on content from a roundtable held in August 2014 in Philadelphia, PA. This certified CME activity is designed for retina specialists and general ophthalmologists involved in the management of patients with retinal disease.

Participants should read the CME activity in its entirety. After reviewing the material, please complete the self-assessment test, which consists of a series of multiple choice questions. To answer these questions online and receive real-time results, please visit http://www.dulaneyfoundation.org and click “Online Courses.” Upon completing the activity and achieving a passing score of over 70% on the self-assessment test, you may print out a CME credit letter awarding 1 AMA PRA Category 1 Credit.™ The estimated time to complete this activity is 1 hour.

Expiration Date: Monday, February 29, 2016
Release Date: February 2015

Learning Objectives

Upon completion of this activity, participants should be able to:
• Describe the current epidemiology of major retinal diseases, including AMD, RVO, and DME
• Assess clinical studies involving new approaches to treat DME
• Utilize expert case examples to differentiate between clinical study dosing protocols and alternative dosing schedules
• Interpret retinal imaging case examples describing the treatment of DME
• Explore the management of treatment complications and secondary therapies
• Educate patients on ophthalmic implications of systemic diabetes management
• Demonstrate optimized patient flow, inventory flow, and office efficiency

Statement of Need

The impact of vision loss due to macular degeneration and ocular manifestations of diabetes is a major public health burden facing our society, given the large aging population at risk for sight-threatening ocular conditions. Significant challenges lie ahead in addressing the needs of patients at risk for vision loss, as well as the impact on society that comes with an increasing population with impaired vision. Macular degeneration, retinal vein occlusion (RVO), and diabetic macular edema (DME) present related physiologic problems for retinal specialists and ophthalmologists in the management of these conditions. Given the coincident systemic disease associated with diabetic retinopathy, the present and predicted burden and health care impact is substantial.

According to the 2012 Vision Problems in the US Report from the Prevent Blindness America Foundation,1 diabetic retinopathy affects more than 7.6 million persons aged 40 years and older.This contributes significantly to the more than $50 billion in direct economic costs due to vision disorders in people aged 40 years and older.

As new therapies enter the market, therapeutic options and dosing strategies can be affected by the cost of treatment, which continues to be a major factor in treatment planning.2 Clinicians need to consider multiple options for therapy in order to properly gauge the right treatment plan for any given patient’s needs.

More broadly, the American Diabetes Association confirms that more than 150 million people across the world are affected by diabetes. By 2025, that number will likely increase to 324 million, including 35% who are expected to develop diabetic retinopathy (DR).3 For nearly 20 years, diabetic retinopathy DR has been documented as the leading cause of blindness and decreased vision-related quality of life in working-age Americans.4,5,6

DME frequently follows the onset of nonproliferative diabetic retinopathy, resulting from abnormal capillary permeability and associated leakage of fluid leakage into the tissue of the retina. In recent years, new understanding of the pathophysiology of DME has focused researchers on the involvement of intracellular hyperglycemia, which induces free radicals (oxidative stress), protein kinase C (PKC) activation, and formation of advanced glycation end products (AGE).7 This process results in hypoxia, ischemia, inflammation, and alteration of vitreomacular interface. Inflammation produces an increase in VEGF production, endothelial dysfunction, leukocyte adhesion, and PKC production. In fact, DR is now considered to be a state of low-grade inflammation.8

When not treated properly, which is often the case, DME progresses to proliferative DR (PDR) and retinal neovascularization, hemorrhaging, and permanent loss of vision. Approximately 50% of untreated patients with PDR will become blind within 5 years of the initial diagnosis.9 Such outcomes can frequently be avoided, however. Both decreased vision and decreased vision-related quality of life may be modified by treatment, including new modalities that provide practitioners with the flexibility of customizing management based on each patient’s needs.

Focal macular laser photocoagulation (FML) has been the primary treatment for DME for more than 2 decades. The Early Treatment Diabetic Retinopathy Study (ETDRS) outcomes focused on the preservation of vision, finding a 50% reduction in the likelihood of severe vision loss with grid-style FML.10 In 2010, the Diabetic Retinopathy Clinical Research Network (DRCR.net) reported a 10-letter gain in nearly one-third of patients treated with a laser, but 19% of subjects experienced progressive visual loss.11 Emerging therapies have recently shown promise, both as adjunctive and possibly first-line alternatives to laser therapy. Several pharmaceutical therapies for DME are currently in clinical development, the majority of which are intravitreally injected anti-inflammatory or anti-angiogenic agents. These include VEGF inhibitors, such as ranibizumab (Lucentis, Genentech), aflibercept (VEGF Trap-Eye, Regeneron) and pegaptanib sodium (Macugen, OSI Eyetech), and intravitreal delivery systems, which release corticosteroids, such as fluocinolone acetonide (Iluvien, Alimera), dexamethasone (Ozurdex, Allergan), and triamcinolone acetonide (I-vation SurModics).

A full knowledge of the dynamics of retinal therapeutic treatment options will be beneficial for arming both specialists and general ophthalmologists who use these drugs with a more complete understanding when counseling patients and initiating treatment. It is expected that providing this education would remove a potential barrier to greater acceptance of this area of disease management. Finally, in the interest of providing more complete care to patients, arming clinicians with current insight into the management strategies for retinal therapeutics may assist in the reduction of treatment complications and prevent further loss of vision.

1. Prevent Blindness America, 2012 Vision Problems in the U.S. Available at: http://www.preventblindness.org/sites/default/files/national/documents/state-fact-sheets/VPUS%2BCOV_FS_US.pdf.
2. Akpek EK, Smith RA. Overview of age-related ocular conditions managed care Iimplications of age-related ocular conditions. Available at: http://www.ajmc.com/publications/supplement/2013/ACE011_13may_AgingEye/ACE011_13May_AgingEye_Akpek.
3. Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003;26(3):917-932.
4. National Institutes of Health. Diabetes in America, 2nd ed. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases: Bethesda, MD, 1995.
5. Klein R, Knudtson MD, Lee KE, et al. The Wisconsin epidemiologic study of diabetic retinopathy: XVIII. The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1 diabetes. Ophthalmology. 1998;105:1801-1815.
6. Hariprasad SM, Mieler WF, Grassi M, et al. Vision-related quality of life in patients with diabetic macular oedema. Br J Ophthalmol. 2008;92:89-92.
7. Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009;54(1):1-32.
8. Singh A, Stewart JM. Pathophysiology of diabetic macular edema. Int Ophthalmol Clin. 2009;49(2):1-11.
9. Hamilton AMP, Ulbig MW, Polkinghorne P. Management of diabetic retinopathy. BMJ Publishing Group: London, 1996.
10. Photocoagulation for diabetic macular edema. Early treatment diabetic retinopathy study report number 1. Early treatment diabetic retinopathy study research group. Arch Ophthalmol. 1985;103:1796-1806.
11. Diabetic Retinopathy Clinical Research Network. Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2010;117:946-953.

Disclaimer

The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of The Dulaney Foundation and Retina Today.

Policy on Privacy and Confidentiality

In accordance with the disclosure policies of The Dulaney Foundation and to conform with ACCME and US Food and Drug Administration guidelines, anyone in a position to affect the content of a CME activity is required to disclose to the activity participants (1) the existence of any financial interest or other relationships with the manufacturers of any commercial products/devices or providers of commercial services and (2) identification of a commercial product/device that is unlabeled for use or an investigational use of a product/device not yet approved.

AMD, RVO, & DME Update: Case Studies in Patient & Practice Management

Jonathan L. Prenner, MD, Moderator; Dean Eliott, MD; Carl Regillo, MD; and Chirag P. Shah, MD, MPH

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