Nw2014 Diabetic Macular Edema Treatment Options

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ways to treat diabetic macular edema, in brief

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Nw2014 Diabetic Macular Edema Treatment Options

  1. 1. The Current Treatment Options for DME ,in Brief Nawat watanachai CMU 01, 2014
  2. 2. treatment options for DME laser laser+antiVEGF antiVEGF new comers
  3. 3. Laser treatment 80’s ETDRS focal/ grid laser to microaneurysms or area of DME
  4. 4. laser + antiVEGF DRCRnet prospective trial comparing standard laser to combination with Lucentis or steroid VA : laser + Lucentis > laser alone
  5. 5. laser + antiVEGF RESTORE trial randomized control VA : Lucentis/ Lucentis+laser > laser 1 yr : Lucentis(7inj) = Lucentis + laser 2 yrs : Lucentis(3.9inj) = Lucentis(3.5inj) + laser
  6. 6. laser + antiVEGF at 1 yr Lucentis Lucentis +laser laser REVEAL Asian population similar to RESTORE VA (ETDRS letter) no of injection +5.9 +5.7 +1.4 7.8 7.4 -
  7. 7. antiVEGF mono therapy Lucentis RISE and RIDE trials double masked, sham-controlled, multicenter Lecentis monthly 0.3mg, 0.5mg, sham 24 mths duration + additional Rx through 36 mths after 3 mtgs : rescue laser could apply
  8. 8. antiVEGF mono therapy Lucentis 24mths sham 0.3mg 0.5mg >15 letters gain (%) 18.1 44.8 39.2 required PRP (%) 11 0 0.8 RISE
  9. 9. antiVEGF mono therapy Lucentis 24mths RIDE sham 0.3mg 0.5mg >15 letters gain (%) 12.3 33.6 45.7 required PRP (%) 12.3 1.6 1.6
  10. 10. antiVEGF mono therapy Lucentis RISE and RIDE 24 mths : macular laser procedures needed sham 1.8, 1.6 lucentis 0.3, 0.8 RISE and RIDE august 2012 : USFDA approved 0.3mg Lucentis for DME Rx
  11. 11. antiVEGF mono therapy Avastin BOLT trials 1.25mg Avastin VS laser non-ischemic center-involving CSME 12 mths : median VA (ETDRS letters) Avastin : +8 laser : -0.5
  12. 12. New Comers Ozurdex sustain-released dexamethasone intravitreal implant 22G needle last 6 mths FDA approved for BRVO/CRVO associated ME non-infectious uveitis
  13. 13. New Comers Dexa implant Ozurdex Haller J, Kuppermann B, Blumenkranz M. Randomized Controlled Trial of an Intravitreous Dexamethasone Drug Delivery System in Patients With Diabetic Macular Edema. Arch Ophthalmol 2010 persistent DME > 90d, 171 eyes observation VS Ozurdex 350mcg, 700mcg 6 mths : BCVA improved > 10 letter observe 23% Ozurdex 350 mcg 19% Ozurdex 700 mcg 30% 6 mths : CRT, FA leakage also better in the 700 mcg groups
  14. 14. New Comers Dexa implant Ozurdex Boyer D, Faber D, Gupta S, et al. Dexamethasone Intravitreal Implant for Treatment of Diabetic Macula r Edema in Vitrectomized Patients. Retina 2011 improved VA and CRT with the 700 mcg implant
  15. 15. New Comers fluocinolone implant Iluvein sustained-release fluocinolone intravitreal implant 25G needle last 2.5-3 yrs
  16. 16. New Comers fluocinolone implant iluvein FAME study prospective randomized trial 3 yrs data 0.2mcg/d, 0.5mcg/d, sham
  17. 17. New Comers fluocinolone implant iluvein FAME study 3 yrs : >15 letters gain 0.2mcg/d 28.7% 0.5mcg/d 27.8% sham 18.9% all phakic developed cataract glaucoma Sx 4.8 and 8.1% approved for treating DME in Europe not in the USA
  18. 18. New Comer Eylea Eylea (Aflibercept) FDA-approved for AMD recombinant fusion protein comprising the key VEGF-binding domains of human VEGF receptors 1 and 2 higher binding affinity versus Lucentis/ Avastin
  19. 19. New Comer Eylea Eylea (Aflibercept) Da Vinci trial : phase II center-involving DME : 5 groups eylea 0.5mg q 4 wks eylea 2 mg q 4 wks eylea 2 mg mthly for 3X, then q 8 wks eylea 2 mg mthly for 3X, then as needed laser
  20. 20. New Comer Eylea Da Vinci trial : phase II 0.5mg 2mg 2mg for 2mg for 3X, then q 3x, then pr 8 wks n laser +9.7 +12.0 +1.3 q4 wks q4 wks mean BCVA (lett ers) +11.0 +13.1 gain>15 letters (%) 40.9 45.5 23.8 42.2 11.4 Mean CRT (mcn) -165.4 -227.4 -187.8 -180.3 -58.4 1 yr
  21. 21. the time to evolve is NOW!! - after >20 yrs, macular focal/grid laser monotherapy is now called into question as the best clinical practice - evidences to change the standard of care for treating center-involving DME to anti-VEGF therapy, particularly ranibizumab with or without laser treatment - adding laser to anti-VEGF therapy doesn’t provide better visual outcomes, it may decrease total injections - The exact best injection treatment protocol has yet to be established - monthly injection - as-needed - “treat and extend” - An interesting result from the RISE and RIDE studies is the suggestion that ranibizumab monotherapy had a lower progression to proliferative retinopathy than the sham arm - Bevacizumab remain readily available alternatives to ranibizumab. - The role of aflibercept has yet to be established but its Phase II data demonstrates promising efficacy and safety - The extended-release steroid devices are intriguing for post-vitrectomized eyes or potentially for resistant cases of DME

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