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The Diabetic Retinopathy Clinical Research Network

The Diabetic Retinopathy Clinical Research Network. Effects of Intravitreal Ranibizumab or Triamcinolone on Diabetic Retinopathy Jennifer K. Sun, MD, MPH Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services.

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The Diabetic Retinopathy Clinical Research Network

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  1. The Diabetic Retinopathy Clinical Research Network Effects of IntravitrealRanibizumab or Triamcinolone on Diabetic Retinopathy Jennifer K. Sun, MD, MPH Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services

  2. DRCR.net Protocol B: Laser vs. IntravitrealTriamcinolone for DME • 840 eyes (693 subjects) • Laser group: N = 330 • 1 mg IVT group: N = 256 • 4 mg IVT group: N = 254 • Major Eligibility Criteria: • VA 20/40 to 20/320 • CSF >= 250 microns on OCT • Visits (and retreatment assessment) every 4 months through 3 years • Primary Outcome: VA at 2 years

  3. Outcome Definition • Progression of retinopathy up to 3 years (any of the following): • Progressed from NPDR at baseline to PDR during follow-up* • Received PRP between baseline and follow-up • Reported a vitreous hemorrhage between baseline and follow-up • Worsened 2 or more levels on the ETDRS diabetic retinopathy scale* • *Based on Reading Center grading of annual fundus photos

  4. Cumulative Probability* of Progression of Retinopathy Months 0 4 8 12 16 20 24 28 32 36 *calculated using the life-table method Note: 14% were censored prior to 2 yr visit and an additional 34% between the 2 and 3 yr visits (of which only 7% had the potential to complete the 3 yr visit due to early closeout of the study) 4

  5. Treatment Group Comparisons at 1, 2, and 3 Years *From a proportional hazards model adjusting for baseline VA, history of prior macular photocoagulation, and baseline retinopathy severity

  6. Cumulative Probability* of Progression of Retinopathy up to 2 Years *calculated using the life-table method 6

  7. Cumulative Probability* of Progression of Retinopathy up to 2 Years *calculated using the life-table method 7

  8. Cumulative Probability* of Progression of Retinopathy up to 3 Years *calculated using the life-table method 8

  9. Cumulative Probability* of Progression of Retinopathy up to 3 Years *calculated using the life-table method 9

  10. Conclusions • As compared with laser, 4 mg IVT may reduce the risk of progression of retinopathy at 1, 2, and 3 years • Difference cannot be explained by an increase in retinopathy caused by focal/grid laser • Similar risk in laser group and 1 mg IVT group • Similar risk of development of PDR in ETDRS immediate laser group (11.1%) and deferred laser group (10.8%) • Use of IVT to reduce risk of progression of retinopathy is not warranted at this time • IVT is associated with cataract and elevated IOP • PDR can be treated relatively safely with PRP

  11. DRCR.net Protocol I: Ranibizumab+ Prompt or Deferred Laser or Tiamcinolone + Prompt Laser for DME • 854 eyes (691 subjects) • Sham + Prompt Laser: N = 293 • Ranibizumab + Prompt Laser: N = 187 • Ranibizumab + Deferred Laser: N = 188 • Triamcinolone + Prompt Laser: N = 186 • Major Eligibility Criteria: • VA ~ 20/32 to 20/320 • Definite retinal thickening due to DME involving the center of the macula • CSF ≥ 250 microns on OCT

  12. Progression/Regression in Diabetic Retinopathy at 1 Year by Baseline Severity *Photos were missing or ungradeable for 61 eyes in the sham+prompt laser group, 72 eyes in the ranibizumab groups, and 33 eyes in the triamcinolone+prompt laser group 12

  13. Progression/Regression in Diabetic Retinopathy at 1 Year by Baseline Severity *Photos were missing or ungradeable for 61 eyes in the sham+prompt laser group, 72 eyes in the ranibizumab groups, and 33 eyes in the triamcinolone+prompt laser group 13

  14. Retinopathy Progression During 1 Year of Follow-up

  15. Conclusions • During the first year, eyes assigned to Ranibizumab groups or Triamcinolone group compared with Laser group were: • More likely to show retinopathy regression • Less likely to show retinopathy progression • Less likely to have a VH or receive PRP • Limitations of this study include large numbers of missing or ungradable photos • Future investigations are needed to definitively demonstrate effect of anti-VEGF therapy or steroid on retinopathy severity

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