Diabetic Retinal Disease: A Growing Epidemic

According to 2018 estimates from the CDC

In 2018, diabetes was the seventh leading cause of death in the United States.2

Diabetic Retinopathy Is Considered a Common, Serious, and Undertreated
Complication of Diabetes3-6

*Adults aged 20 to 74 years.

CDC, Centers for Disease Control and Prevention.

DR Disease Severity Can Progress Quickly and at Any Time

Natural course rate of progression to PDR in 1 year7

Natural course rate of progression to PDR in 1 year: Severe or very severe NPDR (52%), Moderate NPDR (12%), Mild NPDR (5%). Natural course rate of progression to PDR in 1 year: Severe or very severe NPDR (52%), Moderate NPDR (12%), Mild NPDR (5%).

NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy.

Diabetic Macular Edema Is a Complication of DR5

Approximately half of all patients diagnosed with DR are expected to develop DME5

  • More than 30% of untreated patients with DME can progress to moderate vision loss within 3 years8
  • Risk of DME increases with the severity of DR9

DME Can Develop at Any Stage of DR Severity

Cumulative incidence of DME by baseline NPDR severity in anti-VEGF–naïve eyes over 4 years9

Cumulative incidence of DME by baseline NPDR severity in anti-VEGF naive eyes over 4 years. Severe NPDR: 44% - Baseline (n=10,962), Year 2 (n=1585), Year 4 (n=377). Moderate NPDR: 34% - baseline (n=39,116), Year 2 (n=7562), Year 4 (n=2191). Mild NPDR: 21% - Baseline (n=70,050), Year 2 (n=14,003), Year 4 (n=4138). Unspecified NPDR: 15% - Baseline (n=15,466), Year 2 (n=5608), Year (n=2700) Cumulative incidence of DME by baseline NPDR severity in anti-VEGF naive eyes over 4 years. Severe NPDR: 44% - Baseline (n=10,962), Year 2 (n=1585), Year 4 (n=377). Moderate NPDR: 34% - baseline (n=39,116), Year 2 (n=7562), Year 4 (n=2191). Mild NPDR: 21% - Baseline (n=70,050), Year 2 (n=14,003), Year 4 (n=4138). Unspecified NPDR: 15% - Baseline (n=15,466), Year 2 (n=5608), Year (n=2700)

anti-VEGF, anti–vascular endothelial growth factor; NPDR, nonproliferative diabetic retinopathy.

Risk of Developing Vision-Threatening Complications

Proportion of patients with moderately severe to severe NPDR who
progressed to PDR, ASNV, or CI-DME at Years 1 and 2 from baseline10

anti-VEGF, anti–vascular endothelial growth factor; NPDR, nonproliferative diabetic retinopathy.

Awareness Is Limited Among Patients With Diabetic Retinal Disease

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.12

DR Severity Scale (DRSS)

  • Useful for staging the disease and allowing for proper diagnosis and timely intervention with a goal to help prevent or reverse disease
    progression13-16
  • Evaluation of disease by fundus examination: Fundus photography is typically more sensitive in detecting DR lesions than other imaging methods used in practice17

DR severity scores are based on extent and severity of the disease signs.

DRSS

Mild NPDR

img img

Moderate NPDR

img img

Moderately
Severe NPDR

img img

Severe NPDR

img img

PDR

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Images courtesy of Dr. Mohammad Rafieetary. Used with permission. Images were captured at different visits.

*The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.

AAO, American Academy of Ophthalmology; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; NPDR, nonproliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy.

Example of a 2-Step Improvement on the DRSS*

2–Step Improvement on the DRSS 2–Step Improvement on the DRSS

*Adapted from the AAO and ETDRS-DRSS.

†The ETDRS-DRSS classifies moderately severe NPDR as level 47 and severe NPDR as level 53.

AAO, American Academy of Ophthalmology; ETDRS-DRSS, Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale; NPDR, nonproliferative
diabetic retinopathy; PDR, proliferative diabetic retinopathy.

DR severity data
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Dosing flexibility with
EYLEA in DR18

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References
  1. National Diabetes Statistics Report, 2020: estimates of diabetes and its burden in the United States. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://
    www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
  2. Centers for Disease Control and Prevention. Underlying Cause of Death 1999-2018. Data are from the Multiple Cause of Death Files, 1999-2018, as compiled from data provided by the
    57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed November 5, 2020. http://wonder.cdc.gov/ucd-icd10.html
  3. Common eye disorders. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://www.cdc.gov/visionhealth/basics/ced/index.html
  4. Diabetic retinopathy. Centers for Disease Control and Prevention. Accessed November 5, 2020. https://www.cdc.gov/visionhealth/pdf/factsheet.pdf
  5. Diabetic retinopathy. National Eye Institute, National Institutes of Health. Accessed November 5, 2020. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/
    diabetic-retinopathy
  6. Diabetic retinopathy data and statistics. National Eye Institute, National Institutes of Health. Accessed November 5, 2020. https://www.nei.nih.gov/learn-about-eye-health/resources-
    for-health-educators/eye-health-data-and-statistics/diabetic-retinopathy-data-and-statistics
  7. Eye care of the patient with diabetes mellitus. American Optometric Association. Accessed November 5, 2020. http://aoa.uberflip.com/i/1183026-evidence-based-clinical-practice-guideline-eye-care-of-the-patient-with-diabetes-mellitus-second-edition/0?m4=
  8. Gangnon RE, Davis MD, Hubbard LD, et al. A severity scale for diabetic macular edema developed from ETDRS data. Invest Ophthalmol Vis Sci. 2008;49(11):5041-5047. doi:10.1167/
    iovs.08-2231
  9. Moshfeghi AA. Natural history of disease progression in nonproliferative diabetic retinopathy (NPDR) patients in the US. Data presented at: Macula Society 2020 Meeting; February
    20, 2020; San Diego, CA.
  10. Wykoff CC. Intravitreal aflibercept for moderately severe to severe non-proliferative diabetic retinopathy (NPDR): 2-year outcomes of the phase 3 PANORAMA study. Data presented
    at: Angiogenesis, Exudation, and Degeneration Annual Meeting; February 8, 2020; Miami, FL.
  11. Holekamp NM. Overview of diabetic macular edema. Am J Manag Care. 2016;22(suppl 10):s284-s291.
  12. 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. doi:10.1001/jamaophthalmol.2013.6426
  13. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. Accessed November 5, 2020. https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp
  14. Early Treatment Diabetic Retinopathy Study Research Group. Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Ophthalmology. 1991;98(suppl 5):823-833.
  15. 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.
  16. 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. doi:10.1136/bjophthalmol-2017-310664
  17. 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. doi:10.1097/IAE.0b013e318286c952
  18. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. March 2021.