From Outdated to Updated Anthony DeWilde, OD FAAO Disclosure Statement: • KMK Educational Services Please complete your session evaluation using EyeMAP™ online at http:// eyemap.cistems.net Tweet about this session using the official meeting hashtag #aaoptom14 Goals Update on current literature Better understanding of evidence Clinical application of evidence Please silence all mobile devices. Unauthorized recording of this session is prohibited. ! Evidence Based Medicine “The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” ! - David Sackett Evidence Based Medicine Not Perfect Different than “Emminence Based Medicine” Deal with patients NOT populations Human error Evidence Based Medicine Levels of Evidence Evidence Based Medicine Examples of Benefit: How To Read Article Glaucoma Optic Neuritis CRVO Herpes Simplex How To Read Article How many patients? Year in Review Macular Degeneration Randomized? Sponsored Vein Occlusions Placebo? Conflict of Interest? Diabetic Macular Edema Outcomes? Glaucoma Macular Hole Macular Degeneration Macular Degeneration Macular Degeneration Historically could treat with SEVEN-UP Threats to Vision Nothing VIEW Atrophy Laser GEFAL Neovascularization Visudyne COMPLETE Anti-VEGF (Macugen first) HOME SEVEN-UP SEVEN-UP 65 patients from ANCHOR/MARINA > 20/70 37% ! Primary Outcome > 20/70 Secondary Outcome > 20/40 < 20/200 Ophthalmology 2013;120:2292-2299 > 20/40 23% < 20/200 37% SEVEN-UP MARINA/ANCHOR results Gain > 3 lines 40% Lost < 3 lines 90% > 20/40 42% SEVEN-UP VIEW VIEW 4 groups 68% showed active disease on OCT Rq4 (0.5 mg Ranibizumab) ! 2q4 (2 mg Aflibercept) 46% still receiving injections 0.5q4 (0.5 mg Aflibercept) ! 2q8 (2 mg Aflibercept every 8 weeks) When can we stop? ! Retreat criteria Drop in VA of 1 line Persistent fluid OCT >100 micron increase OCT Ophthalmology 2014;121:193-201 VIEW VIEW VIEW Mean injections 96 weeks Aflibercept noninferior to Ranibizumab Primary Outcome < 3 lines at 1 year 92% maintained acuity Secondary - anatomy and change in VA at 52 weeks 33% in all groups achieved 20/40 q4 groups 16 q8 group 11 VIEW GEFAL GEFAL Primary Outcome Every author received financing from Double-masked, randomized, prospective, noninferiority Monthly Aflibercept for 3 months, then PRN Mean change in BCVA ! Secondary Regeneron and Bayer HealthCare Final VA Number of letters gained/lost Ophthalmology 2013;120:2300-2309 GEFAL GEFAL Mean change in BCVA Final VA ~ 20/60 4.8 Aflibercept 2.9 Ranibizumab Number of letters gained/lost ! GEFAL 40% at > 20/40 Gain 15 letters 20% each group Lost 15 letters 10% each group Funded by grant from French Ministry of Health COMPLETE COMPLETE Does suppressing complement system help AMD Using Eculizumab intravenous infusion Primary Outcome 30 patients with GA of 1.25 to 18 mm2 ! COMPLETE 10 low dose Tx, 10 high dose Tx, 10 placebo Inhibition of GA growth – using OCT No difference at 26 or 52 weeks Ophthalmology 2014;121:693-701 COMPLETE COMPLETE HOME Secondary measure Does ForeseeHome result in earlier detection of CNVM? Visual Acuity Was financially supported by Alexion Pharmaceuticals Standard of care vs. ForeseeHome One author was also financially supported VA was similar Tx group gained 3 letters Placebo group lost 3 letters loss SOC could be Amsler Grid or not Ophthalmology 2014;121:535-544 HOME HOME HOME Days to get exam 25% ineligible unable to use device/map visual field 14% stopped using device HOME 5 days for device arm 7.5 for SOC arm 26 (50%) had the device as the first method of alert 237 false alert visits 5 letters difference between 2 arms at time of diagnosis (not treated yet) 26/263 = 10% Positive Predictive Value HOME AMD - Summary Ranibizumab and Aflibercept similar Cost – $1,000 for first year. $700 each subsequent year May be able to give Aflibercept less frequently 8/9 authors have financial disclosure of Notal Vision 25-40% had 20/40 acuity with Anti-VEGF Most had stable vision AMD - Summary Vein Occlusions Vein Occlusions Threats to vision in BRVO Threats to vision in CRVO Complement inhibition does not help Geographic Atrophy Macular edema Macular edema ForeseeHome for early detection. Is it worth it? Macular ischemia Macular ischemia Proliferative (mostly V-Heme) Proliferative (mostly NVG) Vein Occlusions Vein Occlusions Vein Occlusions Intravitreal steroids improved vision BRVO historically treated CRVO historically treated If NV, treat with sector PRP If NVG, treat with PRP If edema, wait 3 months - then laser If edema, no treatment Complications Cataract Glaucoma Vein Occlusions RETAIN RETAIN RETAIN BRVO 2 year results of BRAVO/CRUISE trials GALILEO 80% had > 20/40 50% still needed occasional injection after 4 yrs Ranibizumab for BRVO/CRVO COPERNICUS Ophthalmology 2014;121:209-219 RETAIN RETAIN 1 year results of Aflibercept for CRVO CRVO Average acuity for CRVO was 20/100 despite treatment Only 44% showed resolved central retinal fluid Best predictor was entering acuity GALILEO Aflibercept versus sham Financially supported by Genentech Injection every 4 weeks for 20 weeks From 24-52 weeks, PRN dosing Ophthalmology 2014;121:202-208 GALILEO GALILEO 3-line improvement Development of NV 60% Aflibercept No difference between perfused and non-perfused retinas in the Aflibercept treated patients 32% Sham Average entrance acuity 20/100 GALILEO Do we still need Fluorescein Angiography? 3-line improvement = 20/50 GALILEO 6% Aflibercept 9% Sham In CVOS this was 35% in control group (all ischemic) Reduced to 22% with PRP COPERNICUS 2 year results for Aflibercept for CRVO Same study as GALILEO but different region Funded by Regeneron Pharmaceuticals Year 2 - sham group received PRN Aflibercept COPERNICUS 3-line improvement 56% Aflibercept 12% Sham ! Am J Ophthalmol. 2013 Mar;155(3):429-437.e7 COPERNICUS COPERNICUS Vein Occlusion - Summary Development of NV year 1 0% Aflibercept 7% Sham BRVO improve on Aflibercept Financially supported by Regeneron Pharmaceuticals CRVO improve on Aflibercept Development of NV year 2 6% Aflibercept 8% Sham + PRN Vein Occlusion - Summary Longterm outcome of CRVO shows guarded prognosis Diabetic Macular Edema Diabetic Macular Edema Threats to Vision Very little NV on anti-VEGF treatment Does this effect last? RESTORE RISE/RIDE Macular Edema Macular Ischemia Proliferative NVG V-Heme Traction RD Diabetic Macular Edema Diabetic Macular Edema Diabetic Macular Edema Historically treated with Treatment Criteria (CSME) Laser Focal Grid Intravitreal steroids Threats to Vision Macular Edema Diabetic Macular Edema Retinal thickening within 500 microns of fovea Exudate within 500 microns of fovea w/ adj thickening >1 disc area of thickening within 1 disc diameter RESTORE RESTORE 2 year results of Ranibizumab for DME Year 1 Treatment Criteria - Anti-VEGF Ranibizumab After year 1, PRN based on set criteria Central retinal thickening Ranibizumab plus laser Visual acuity <20/30 Laser Anatomy ! Ophthalmology 2013;120:2004e2012 RESTORE RESTORE RESTORE Ranibizumab mean 8 letters improved Mean acuity in all groups was 20/50 Similar outcomes at years 1 and 2 Ranibizumab plus laser mean 7 letters improved 2 letters improved to 5 letters improved 19% had 20/30 RISE/RIDE 3 year results of Ranibizumab for DME Ranibizumab versus sham 40% had 20/30 or better 22% had 20/30 RISE/RIDE Ophthalmology 2013;120:2013-2022 RISE/RIDE Similar results to 1 and 2 yr in Ranibizumab group 3-line improvement (Avg entrance 20/80) 37% Ranibizumab 0.3 mg 40% Ranibizumab 0.5 mg 20% Sham then PRN Ranibizumab Both groups could have rescue laser if needed After 2 years, sham patients eligible for 0.5mg Ranibizumab Laser only improved w/ addition of Ranibizumab 20/40 60% Ranibizumab 0.5 mg 42% Sham RISE/RIDE DME - Summary Glaucoma Safety CVA Ranibizumab effective for DME 5% Ranibizumab 0.5 mg Threat to Vision Up to 60% reading acuity at 3 years MI 3.5% Ranibizumab 0.5 mg (7% in 0.3 mg) Fixation involved VF loss Peripheral VF loss? When can we stop? Death 0.3 mg is safer than 0.5 mg 6% Ranibizumab 0.5 mg Glaucoma Glaucoma Glaucoma Trab and Shunt are comparable Treated with Topical Surgery Oral Trabeculectomy Laser Tube shunt Surgery Different studies = Different results Trab vs. Tube Similar IOP and Post-op IOP meds 47% Trab failed 30% Tube failed Glaucoma Ahmed (valved) Glaucoma Baerveldt (non-valved) Bleb forms - 4-6 weeks Need to manipulate post-op More hypotony Allows flow immediately post-op Fewer hypotony complications Ahmed vs. Baerveldt Ahmed vs. Baerveldt 50% had secondary glaucoma Failure 1/3 failed trabeculectomy IOP outside of 5-18 mmHg range Mean pre-op IOP 31 +/- 10 mmHg < 20% reduction from baseline On 3 +/- 1 meds average Vision-threatening complications Loss of light perception Ophthalmology 2013;120:2232-2240 Ahmed vs. Baerveldt Ahmed vs. Baerveldt Ahmed vs. Baerveldt Secondary outcome measures IOP Failure Medication use Ahmed 51% Ahmed Visual acuity Baerveldt 34% Baerveldt 14 mmHg Complications Ahmed vs. Baerveldt Mean IOP Ahmed vs. Baerveldt 16 mmHg Ahmed vs. Baerveldt Post-op Medications Complications Hypotony Ahmed 2 Ahmed 52% Ahmed Baerveldt 1 Baerveldt 62% Baerveldt 6% 0% Ahmed vs. Baerveldt Vision (Median) Macular Hole Macular Hole ILM Peel with No Face-Down Positioning Ahmed Baerveldt 20/200 Current standard of care 20/200 ILM peel with no face-down position 5% of each group progressed to NLP Ophthalmology 2013;120:1998-2003 Macular Hole Macular Hole Macular Hole Cochrane Review 4 randomized clinical trials Broad ILM peel Visual outcomes same at 6 months Repeat surgery less in ILM peel group 2 recent trials that evaluated postoperative positioning No evidence of improved success with face-down positioning 68 patients with idiopathic full thickness macular hole Vitrectomy, ERM/ILM peel, SF6 Reading position post-op Macular Hole Macular Hole 100% closure Macular Hole Unknown Benefits Mean pre-op 20/100 Reduce burden Similar outcomes Mean post-op 20/40 No complications Will surgeons adopt this Can results be replicated Surgeon dependent?
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