Diabetic Eye Disease: a Growing Epidemic

According to CDC estimates in 2015,

Diabetes mellitus affected 9.4% of Americans (30.3 million people)1
24%
of adults with diabetes
mellitus were undiagnosed1
 34%
of adults aged 18 and older
had prediabetes1
 33%
of the U.S. population
is expected to have diabetes
mellitus by 20502
Diabetes Epidemiology: 24% of adults with diabetes were undiagnosed, 34% of adults aged 18 and older had prediabetes, and 33% of the U.S. population is expected to have diabetes by 2050. Diabetes Epidemiology: 24% of adults with diabetes were undiagnosed, 34% of adults aged 18 and older had prediabetes, and 33% of the U.S. population is expected to have diabetes by 2050.

In 2015, diabetes mellitus was the 7th leading cause of death in the U.S.1

  • CDC = Centers for Disease Control and Prevention
Diabetic Retinopathy is a common, serious, and undertreated complication
of diabetes3–6

DR is the leading cause of new cases of blindness among people with diabetes between the ages of 20 and 74 years4

DIABETIC RETINOPATHY CAN AFFECT ≈1 OUT OF 3 ADULTS OVER AGE 40 WITH DIABETES5
Diabetic retinopathy can affect approximately 1 out of 3 adults over 40 with diabetes.

Hyperglycemia may be the underlying cause of DR and DME7

Diabetic Retinopathy can put patients at risk of vision loss3
  • Diabetic Retinopathy detection can occur at various levels of severity3
In a 2013 analysis, the majority of patients with DR were diagnosed with moderate to severe nonproliferative DR (NPDR) and proliferative DR (PDR)8

46% Mild NPDR
41% Moderate to Severe NPDR
13% PDR
Of patients diagnosed with diabetic retinopathy, 46% had mild NPDR, 41% had moderate to severe NPDR, and 13% had PDR. Of patients diagnosed with diabetic retinopathy, 46% had mild NPDR, 41% had moderate to severe NPDR, and 13% had PDR.

Based on Decision Resources analysis of the estimated 5.8 million adults with DR in 2012.

  • DR disease severity can progress to more severe levels at any time3,8

DME is a complication of DR that can occur anytime3

Half the patients newly diagnosed with DME present with visual acuity of worse than 20/409

  • 50% of people with DR are expected to develop DME4
  • Risk of DME increases with the severity of DR4
DME is a complication of DR that can occur anytime. Half the patients newly diagnosed with DME present with visual acuity of worse than 20/40. 50% of people with DR are expected to develop DME. Risk of DME increases with the severity of DR. DME is a complication of DR that can occur anytime. Half the patients newly diagnosed with DME present with visual acuity of worse than 20/40. 50% of people with DR are expected to develop DME. Risk of DME increases with the severity of DR.
Awareness is limited among patients with diabetic eye disease10

In a 2014 study, the majority of patients with DR or DME reported that they had never been told by a doctor that diabetes mellitus was affecting their eyes11

Chart showing that 55% of patients with DME and 74% of patients with DR reported that they had never been told by a doctor that diabetes was affecting their eyes. Chart showing that 55% of patients with DME and 74% of patients with DR reported that they had never been told by a doctor that diabetes was affecting their eyes.

Cross–sectional analysis of 2005–2008 National Health and Nutrition Examination Survey (NHANES) data; N=798 participants with self–reported diabetes stratified by DR and DME status.

DR Severity Scale (DRSS)
  • Useful when describing the clinical features of DR at various stages, allowing for proper diagnosis and appropriately timed intervention with a goal to help stop or reverse disease progression12–15
  • Diabetic Retinopathy detection of disease by fundus examination: Fundus photography is typically more sensitive in detecting DR lesions than other imaging methods used in practice16

DRSS

DR severity scores are based on extent and severity of Diabetic Retinopathy ocular findings.

Mild Nonproliferative Diabetic Retinopathy (NPDR)12-15

Diabetic Retinopathy exudates (hard and soft), diabetic eye hemorrhage, venous beading, or intraretinal microvascular abnormalities, but less extensive than moderate NPDR

Images captured at different visits.

Moderate
NPDR12-15

More extensive findings than mild NPDR, but less extensive than moderately severe NPDR

Images captured at different visits.

Moderately Severe NPDR12-15,*

Any of the following:

  • Mild intraretinal
    microvascular abnormalities
    in 4 quadrants
  • Severe retinal hemorrhages
    in 2-3 quadrants
  • Venous beading in
    1 or more quadrants

Images captured at different visits.

Severe
NPDR12-15,*

Any of the following (4-2-1 rule) and no signs of PDR:

  • Severe intraretinal
    hemorrhages and
    microaneurysms in each of
    4 quadrants
  • Definite venous beading in 2 or more quadrants
  • Moderate intraretinal
    microvascular abnormalities
    in 1 or more quadrants

Images captured at different visits.

Proliferative Diabetic Retinopathy (PDR)12-15

One or both of the following:

  • Neovascularization
  • Vitreous/preretinal hemorrhage

Images captured at different visits.

Fundus photography example of mild nonproliferative Diabetic Retinopathy (NPDR). Fundus photography example of moderate nonproliferative Diabetic Retinopathy (NPDR). Fundus photography example of moderately severe nonproliferative Diabetic Retinopathy (NPDR). Fundus photography example of severe nonproliferative Diabetic Retinopathy (NPDR). Fundus photography example of severe proliferative Diabetic Retinopathy (PDR).
  • Images courtesy of Dr. Mohammad Rafieetary. Used with permission.

Scale is adapted from the Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale (ETDRS–DRSS): An established grading scale for measuring the severity of DR, as well as the American Academy of Ophthamology (AAO).

  • *The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.
Example of a 2–Step Improvement on the DRSS*

Mild
Nonproliferative
DR (NPDR)

Moderate NPDR

Moderately
Severe NPDR†

Severe NPDR†

Proliferative
DR (PDR)

Visual showing an example of a 2-step improvement on the Diabetic Retinopathy Severity Scale from Severe Nonproliferative DR (NPDR) to Moderate NPDR.
Visual showing an example of a 2-step improvement on the Diabetic Retinopathy Severity Scale from Severe Nonproliferative DR (NPDR) to Moderate NPDR.
  • *Adapted from the AAO and ETDRS–DRSS.
  • †The ETDRS–DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.

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See More Important Safety Information and Indications
  • CONTRAINDICATIONS: EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Important Safety Information INDICATIONS

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

Please see the full Prescribing Information for EYLEA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

References
  1. National Diabetes Statistics Report, 2017. Centers for Disease Control and Prevention website. http://bit.ly/2ZVESZH. Accessed July 12, 2019.
  2. Number of Americans With Diabetes Projected to Double or Triple by 2050 [press release]. Centers for Disease Control and Prevention website. https://www.cdc.gov/media/pressrel/2010/r101022.html. Accessed July 12, 2019.
  3. Facts About Diabetic Eye Disease. National Eye Institute, National Institutes of Health website. http://bit.ly/2JLRRLW. Accessed July 12, 2019.
  4. Common Eye Disorders. Centers for Disease Control and Prevention website. http://bit.ly/2YNSBFA. Accessed July 12, 2019.
  5. Diabetic Retinopathy. Centers for Disease Control and Prevention website. http://bit.ly/2BKTVCTS. Accessed July 12, 2019.
  6. Diabetic Eye Disease. National Eye Institute, National Institutes of Health website. http://bit.ly/2N3PQKZ. Accessed July 12, 2019.
  7. Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124-136.
  8. BioTrends Research Group. TreatmentTrends®: Diabetic Retinopathy/Diabetic Macular Edema (U.S.) 2013.
  9. Vestrum Health Anonymized Electronic Health Record Data.
  10. Holekamp NM. Overview of diabetic macular edema. Am J Manag Care. 2016;22(10 suppl):s284-s291.
  11. Bressler NM, Varma R, Doan QV. Underuse of the health care system by persons with diabetes mellitus and diabetic macular edema in the United States. JAMA Ophthalmol. 2014;132(2):168-173.
  12. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. http://bit.ly/2SX3H2D. Accessed February 5, 2020.
  13. Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy: ETDRS report number 12. Ophthalmology. 1991;98(5 suppl):823-833.
  14. Davis MD, Fisher MR, Gangnon RE, et al. Risk factors for high-risk proliferative diabetic retinopathy and severe visual loss: Early Treatment Diabetic Retinopathy Study Report #18. Invest Ophthalmol Vis Sci. 1998;39(2):233-252.
  15. Staurenghi G, Feltgen N, Arnold JJ, et al; for the VIVID-DME and VISTA-DME Study Investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018;102(7):954-958.
  16. Gangaputra S, Lovato JF, Hubbard L, et al; for the ACCORD Eye Research Group. Comparison of standardized clinical classification with fundus photograph grading for the assessment of diabetic retinopathy and diabetic macular edema severity. Retina. 2013;33(7):1393-1399.