Associate Clinical Professor of Ophthalmology University of South Florida Tampa FL Case Presentation 71 year old woman with type 2 diabetes for 12 years with gradually decreasing vision OU Visual acuity R2050 L20125 ID: 1041952
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1. Steroids and DMEScott E. Pautler, M.D.Associate Clinical Professor of OphthalmologyUniversity of South FloridaTampa, FL
2. Case Presentation71 year old woman with type 2 diabetes for 12 years with gradually decreasing vision OUVisual acuity: R-20/50, L-20/125Slit lamp: 2+ nuclear sclerosisIOP 18 OUFundus: DME OU; moderate NPDR OU
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4. 3/23/2009
5. Right EyeLeft EyeTreatments:Focal – 2IVK – 10CE/IOLTreatments:Focal – 3IVK – 13CE/IOLVTX/ILM peelPRP -2
6. 2/5/2014
7. Visual Acuity and OCT OutcomesDateEyeCSMT (µ)VA3/23/2009Right39820/50Left39720/1252/5/2014Right26720/20Left49020/100
8. Steroid Mechanism of ActionDecrease VEGF productionWidespread anti-inflammatory effectsMore rapid onset and more profound initial effect on edema than anti-VEGF agents Adverse effects: cataract, glaucomaPre-injection IVTA1 month later
9. Steroid Agents
10. Triamcinolone vs Focal/Grid LaserDRCR Protocol B: 840 eyesThree-year resultsProblems: 79% of eyes were phakic and IVTA dosing interval was ≥ 4 monthsTreatmentMeanBCVA gainsΔ CSMTIn micronsCataract SurgeryGlaucoma SurgeryGlaucomaDropsFocal/Grid+5 letters-158003%IVTA 1 mg0 letters-10346%02%IVTA 4 mg0 letters-11483%4 (1.6%)12%
11. Combination IVTA + Focal/Grid Laser (FGL)DRCR Protocol I: Pseudophakic eyes (206)Two-year resultsTreatmentMeanΔ BCVA (letters)MeanΔ CSMT (μ)IVTA 4 mg + FGL+8 -128 Sham + FGL+5 -145 IVR + Prompt FGL+5 -126 IVR + Deferred FGL+9 -148
12. Triamcinolone OptionsTriamcinoloneFDA approvedCrystal SizeDissolutionProfileCostPseudoEndophthPreservedNo 18.86 μFaster$9.32≤7%Preservative-FreeYes11.51 μSlower$157.58≤1%
13. Dexamethasone ImplantRecently approved by FDA for DME Bio-erodible Duration ≤6 monthsOzurdex MEAD Study Group 2014:1048 eyes; 20/50-20/200; CRT ≥300μ; 3-yearTreatment≥15 letter improvementMean CRT (μ)CataractGlaucomaSurgerySham injection12%-4220%0%Dex 0.35 mg18.4%-10864%0.3%Dex 0.70 mg22.2%-11268%0.6%
14. Dexamethasone ImplantBEVORDEX Study (AAO subspecialty meeting)1-year result of RCTbevacizumab vs dexamethasoneDexamethasone superior functional and anatomic outcomes in pseudophakic eyesMean number of injections:3.7 Dexamethasone injections8.6 bevacizumab injections
15. Fluocinolone ImplantRecently approved by FDA for DME Non-responders; Duration ≤3 yearsFAME Study 2012:953 eyes; failed FLT; 20/50-20/400; CRT ≥250μ; 3-year studyTreatment≥15 letter improvementMean CRT (μ)CataractGlaucomaSurgerySham injection*21%NG51%0.5%Fluo 0.2 μg/d33%NG82%4.8%Fluo 0.5 μg/d32%NG89%8.1%*Rescue treatment with focal laser and/or anti-VEGF occurred more often in Sham
16. Steroids and IOPRisk Factors: Glaucoma, OHT, steroid response, young age, higher loading doseSteroid Agent(values adjusted by control group)≥10mmoverbaseline≥25mmat anyexamAnyIOPmedsSurgeryFor IOPAttritionby 3 yearsTriamcinolone 1 mg18% (14%)-2% (0%)0% (0%)64%Triamcinolone 4 mg33% (29%)-12% (9%)4% (4%)64%Dexamethasone Impl 0.70 mg28% (24%) 32% (28%)42% (33%)1% (1%)42%Fluocinolone Impl 0.19 mg34% (24%)20% (16%)38% (24%)5% (4%)30%
17. Case SelectionPseudophakic, Non-Glaucoma/Suspect EyesAC IOL: consider avoiding an implantPost vitrectomy: consider avoiding IVTA (storm)Prior glaucoma surgery offers limited protection against steroid-IOP response
18. Case SelectionDME resistant to anti-VEGF/laser*Macula-threatening exudates (BEVORDEX)One-time use for DME prior to surgery:PRP laser cataract surgery* Fluocinolone implant relatively more effective in chronic edema (>3yrs)
19. Steroid SelectionTriamcinoloneLess expensive (Kenalog®)More frequent injectionGreater peak/trough effectSteroid implantMore expensiveFewer injectionsBetter pharmacokinetics (Iluvien®>Ozurdex®)
20. Thank youScott E. Pautler, M.D.Tampa, FL