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Sponsored by the National Eye Institute,

A Randomized Trial Comparing Intravitreal Triamcinolone to Focal/Grid Photocoagulation for Diabetic Macular Edema. Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services. Intravitreal Triamcinolone for DME.

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Sponsored by the National Eye Institute,

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  1. A Randomized Trial Comparing Intravitreal Triamcinolone to Focal/Grid Photocoagulation for Diabetic Macular Edema Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services.

  2. Intravitreal Triamcinolone for DME • 2001-2002: potential benefit first reported1,2 • Short term improvement in visual acuity • Rapid decrease in retinal thickening on OCT • 2005: 91% of retina specialists surveyed (N=371) would use IVT for persistent DME3 • Community equipoise present:Randomized, controlled comparison with standard care (focal/grid photocoagulation) needed 1- Jonas JB, et al. Am J Ophthalmol 2001;132:425-7 2- Martidis A, et al. Ophthalmology 2002;109:920-7 3- American Society of Retina Specialists Preferences and Trends Survey 2005

  3. DRCR.net Study Design • Multicenter, randomized clinical trial • Three treatment groups • Focal/grid laser • 1 mg IVT • 4 mg IVT • Duration of follow-up: 3 years • Follow-up visits and re-treatment as often as every 4 months

  4. Primary Study Objective • To compare the efficacy and safety of preservative-free IVT (1 mg or 4 mg) with focal/grid laser

  5. Efficacy Outcomes • Primary outcome assessment at 2 years • Primary outcome measure: visual acuity • Scientific objective: mean change in VA • Regulatory objective for FDA: proportion with decrease in VA letter score >15 • Secondary measure: Retinal thickening on OCT

  6. Major Eligibility Criteria • At least 18 years old • Type 1 or type 2 diabetes • Center-involved DME confirmed on OCT • (central subfield thickness >250 microns) • Best-corrected VA letter score 73 to 24 • (Snellen equivalent 20/40 to 20/320)

  7. Results

  8. Study Enrollment and Completion • 840 eyes (693 subjects) enrolled at 88 clinical sites (2004-2006) • Treatment Groups • Laser: N = 330 • 1 mg: N = 256 • 4 mg: N = 254 • 2-year visit completion rate • 88% excluding deaths

  9. Primary Outcome:Mean Change in Visual Acuity at 2 Years * Adjusted for baseline VA and prior focal/grid laser

  10. Median Visual Acuity in Laser and IVT Treated Eyes 20/32 - 20/40 - # + Visual * # * # Acuity * 20/50 - Score 20/63 - 20/80 - P < 0.005 * Laser vs. 1mg # Laser vs. 4mg + 1mg vs. 4mg Months 10

  11. % Increased >10 Letters in Laser and IVT Treated Eyes Months 11

  12. Visual Acuity at 2 YearsAccording to Lens Status Includes only subjects with a 2 year visit

  13. Mean Visual Acuity Over 3 Years in All Eyes 20/32 20/40 Visual Acuity 20/50 Score 20/63 20/80 20 36 8 24 28 0 16 12 32 4 Months 13

  14. OCT Central Subfield (CSF) Thickening at 2 Years

  15. Median OCT Central Subfield Thickness in Laser and IVT Treated Eyes Central Subfield Thickness (microns) Months 15

  16. Change in CSFfrom 2 Years to 3 Years* * Among completers of both the 2 year and 3 year visit 16

  17. Major Ocular Adverse EventsDuring 2 Years of Follow-up * 1 case of endophthalmitis occurred after vitrectomy, not related to study drug injection † Judged not necessarily related to treatment ‡ Includes vitrectomy for diabetic macular edema, vitreous hemorrhage or other cause

  18. Intraocular Pressure During 3 Years of Follow-up* * Among completers of the 3 year visit 18

  19. Cataract Surgery Prior to 2 Years

  20. Cumulative Probability of Cataract Surgery* Over 3 Years 83% 46% 31% 4 8 16 20 12 24 36 28 32 Months * Among phakic eyes at baseline 20

  21. Conclusion • VA benefit in 4 mg IVT group at 4 months consistent with published case series • However, no difference in VA between IVT groups and laser group by 1 year • By 2 years, there was a greater VA benefit and fewer side effects (IOP and cataract) in laser group compared with the IVT groups • 3 year results similar to the 2 year results • OCT results mirrored VA results

  22. Conclusion • Results re-affirm importance of laser in management of DME • Focal/grid currently most effective treatment for patients with DME (with characteristics similar to those enrolled in this trial) • Focal/grid currently benchmark against which other new treatments for DME should be compared in clinical trials for DME

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