The Diabetic Retinopathy Clinical Research Network. Management of DME in Eyes with PDR

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1 The Diabetic Retinopathy Clinical Research Network Management of DME in Eyes with PDR 1

2 What Has Been Learned? Diabetic Retinopathy Treatment Protocol F: Results suggest that clinically meaningful differences are unlikely in OCT thickness or visual acuity following application of PRP in 1 sitting compared with 4 sittings in absence of DME. These results suggest PRP costs to some patients in terms of travel and lost productivity as well as to eye care providers could be reduced. Diabetic Retinopathy Clinical Research Network. Observational study of the development of diabetic macular edema following panretinal (scatter) photocoagulation given in 1 or 4 sittings. Arch Ophthalmol.2009 Feb;127(2):

3 Randomized Trial Evaluating Short-Term Effects of Intravitreal Ranibizumab or Triamcinolone Acetonide on Macular Edema Following Focal/Grid Laser for Diabetic Macular Edema in Eyes Also Receiving Panretinal Photocoagulation. (Protocol J) Diabetic Retinopathy Clinical Research Network. Randomized Trial Evaluating Short-Term Effects of Intravitreal Ranibizumab or Triamcinolone Acetonide on Macular Edema Following Focal/Grid Laser for Diabetic Macular Edema in Eyes Also Receiving Panretinal Photocoagulation. Retina June;31(6):

4 Results Mean Change from baseline to 14 Weeks Sham+ Focal/Grid/P RP Laser N = 123 Ranibizumab+ Focal/Grid/PR P Laser N = 113 Triamcinolo ne+ Focal/Grid/P RP Laser N = 109 Visual Acuity Difference in mean change from Sham +Focal/Grid/PRP Laser [P Value]* OCT central subfield thickening (µm)** Difference in mean change from Sham [P < 0.001] +6.7 [P < 0.001] *Adjusted for baseline visual acuity, number of planned PRP sittings, and correlation between 2 study eyes. ** Missing (or un-gradeable) data follows for the sham+focal/grid/prp laser group, ranibizumab+focal/grid/prp laser group, and Focal/Grid/PRP triamcinolone+focal/grid/prp Laser laser groups, respectively: 3, 3, 2 [P = 0.007] [P < 0.001] Adjusted for baseline OCT retinal thickness and visual acuity, number of planned PRP sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons. 4 [P Value]

5 Mean Change in Visual Acuity* from Mean Change in Visual Acuity from Baseline (letter score) Baseline Randomized Phase Safety Phase (DME treatment according to protocol) (DME treatment at investigator discretion) Sham+Focal/Grid/PRP Laser Ranibizumab+Focal/Grid/PRP Laser Triamcinolone+Focal/Grid/PRP Laser * Values that were ±30 letters were assigned a value of 30 5

6 Mean Change in Retinal Thickness from Baseline Mean Change in OCT Central Subfield Thickness from Baseline (microns) 120 Sham+Focal/Grid/PRP Laser 100 Ranibizumab+Focal/Grid/PRP Laser 80 Triamcinolone+Focal/Grid/PRP Laser Randomized Phase (DME treatment according to protocol) Safety Phase (DME treatment at investigator discretion) Safety Phase (DME discretion) 6

7 Randomized Phase Summary 14 week primary outcome visit: On average, both ranibizumab and triamcinolone statistically significantly improve visual acuity and retinal thickness compared to sham injection in eyes with central DME receiving focal/grid laser and requiring prompt PRP Focal/grid given with PRP does not, on average, reduce edema in shortterm (in contrast to focal/grid in absence of PRP which does reduce edema) Safety Phase 14 week to 56 week visits: Differences in visual acuity and retinal thickness outcomes above no longer identified 7

8 Conclusion The addition of 1 intravitreal triamcinolone or 2 ranibizumab injections in eyes receiving focal/grid laser for DME and PRP is associated with better visual acuity and decreased macular edema by 14 weeks, but these effects are not maintained by 56 weeks in absence of continued injections for persistent or recurrent DME. 8

9 Coexisting PDR and DME 49 yo BM NIDDM x 20 yrs VA 20/50 RE 20/200 LE 9

10 Coexisting PDR and DME Irregular FAZ, temporal capillary non-perfusion, NVE Capillary nonperfusion adjacent to FAZ; fluorescein in cystoid spaces 10

11 No DME RE 11

12 But substantial DME LE 12

13 Coexisting PDR and DME LE Capillary nonperfusion adjacent to FAZ; fluorescein in cystoid spaces NVE nasally 13

14 Coexisting PDR and DME Treatment OD One week later VA 20/25 RE PRP OD 2331 spots Pascal laser (complete) 200 microns, 20 msec, 343 mw, Mainster 165 lens No anti-vegf or steroids given Treatment OS One week later VA 20/200 LE and RZB 0.3 mg IVT given 2 weeks after RZB, PRP OS 1683 spots Pascal laser (incomplete), 200 microns, 20 msec, 275 mw, Mainster 165 lens 14

15 2 weeks post PRP RE, no new DME, VA 20/25 15

16 2 weeks post ranibizumab LE, DME persists but better, VA 20/200, PRP done 16

17 4 weeks post RZB, 2 weeks post PRP LE, DME reduced, VA 20/200 17

18 Conclusions and Opinions Management of coexisting DME and PDR is challenging but pharmacologic treatment of the DME component reduces the risk of exacerbation of the DME post-prp in the short term In eyes without DME that receive PRP for PDR or severe NPDR, the risk of developing DME post-prp is low, even if the PRP is completed in one sitting Extrapolating current knowledge of anti-vegf treatment of center involved DME from multiple trials, treatment of DME with anti-vegf therapy prior to PRP should be continued post laser until the DME is stabilized or resolved to achieve the best visual outcomes Additionally, focal/grid laser plus anti-vegf injection prior to PRP may not be necessary since no additional benefit of laser has been found when treating center involved DME alone Protocol S will give additional data on the effect of ranibizumab on DME in the setting of PDR treated with PRP 18

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