First Experience with Ocriplasmin in Frankfurt Tillmann Eckert Eye Clinic Klinikum Frankfurt Hoechst Frankfurt am Main Germany 8 / 2013 1.0 WG 73y female phakic ! ! ! ! ! ! ! ! 10 / 2013 0.8 ! ! ! ! ! ! ! ! 11 / 2013 0.6 ! ! ! ! ! ! ! 12 / 2013 0.4 Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes Peter Stalmans, Matthew S. Benz, Arnd Gandorfer, Anselm Kampik, Aniz Girach, Stephen Pakola, and Julia A. Haller, for the MIVI-‐TRUST * Study Group N Engl J Med 2012; 367; 606 -‐615 * Microplasmin for Intravitreous Injection – Traction Release without Surgical Treatment ! 2 multicenter, randomized, double-‐blind, placebo-‐controlled, phase 3 studies ! ◆ VMA ± epiretinal membrane oder macular hole ≤ 400 μm ◆ visual acuity ≤ 0.8 ◆ n = 652 (188 placebo = NaCl) ◆ exclusion criteria ◆ PDR or RVO ◆ exsudative AMD ◆ aphakia ◆ high myopia more than -‐ 8 dpt ◆ large macular hole > 400 μm ◆ post PPV or central laser coagulation, post ophthalmic operations in last 3 months Nonsurgical Resolution of Vitreomacular Adhesion (VMA) with Ocriplasmin versus Placebo to Day 180. Stalmans P et al. N Engl J Med 2012;367:606-‐615. Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes Peter Stalmans, Matthew S. Benz, Arnd Gandorfer, Anselm Kampik, Aniz Girach, Stephen Pakola, and Julia A. Haller, for the MIVI-‐TRUST * Study Group N Engl J Med 2012; 367; 606 -‐615 Placebo n = 188 % Ocriplasmin n = 464 p after 28 days resolution of vitreomacular adhesion 10,1 26,5 < 0,001 with epiretinal membrane 1,5 8,7 0,046 without epiretinal membrane 14,3 37,4 < 0,001 total posterior vitreous detachment 3,7 13,4 < 0,001 closure of macular hole 10,6 40,6 < 0,001 resolution of vitreomacular adhesion 17,0 40,6 0,004 vitrectomy 26,6 17,7 0,02 improvement in visual acuity >= 3 lines 6,4 12,3 0,02 11,4 25,1 0,01 after 6 months if preop VA < 0,4 Indications for Enzymatic Vitreolysis Gass Macular Hole Classification Stage 0 ! International Vitreomacular Traction Study Classification vitreomacular adhesion VMA Stage 1 impending MH vitreomacular traction VMT Stage 2 small MH small or medium MH with VMT Stage 3 large MH medium or large MH with VMT Stage 4 large MH with PVD ! small, medium or large MH with PVD FTMH = full thickness macular hole PVD = posterior vitreous detachment The International Vitreomacular Traction Study Group Classification of Vitreomacular Adhesion, Traction, and Macular Hole Jay S. Duker et al. Ophthalmology 2013;120:2611-2619 No Indications for Enzymatic Vitreolysis ! Ê asymptomatic VMA (vitreomacular adhesion) Ê large FTMH (full thickness macular hole) > 400 μm Ê every FTMH without vitreomacular traction Ê epiretinal membrane Ê high myopia 415 μm day 28 post Jetrea elsewhere 0.5 epiretinal membrane ! day 6 post PPV 0.6 EK 70 Jetrea : Ocriplasmin Thrombogenics / Alcon Ê active fragment of plasmin Ê protease (fibronectin, laminin) Ê -‐20° C Ê 125 μg / 0.1 ml Ê EU: available since mid 2013 Ê sVMT / FTMH with VMT< 400 μm Ê 3830 € to 3248 € preop 0,3 TA 49y ! ! ! ! ! ! ! ! ! 3 weeks later ! ! ! ! ! ! ! ! ! preop 0,3 TA 49y ! ! ! ! ! ! ! ! ! 3 weeks later ! ! ! ! ! ! ! ! ! Patients Ê n = 18 Ê follow up 17 patients: 9 male, 8 female Ê Age 60 – 91 (72.5) years Ê VMTS 11 Ê VMTS with macular hole 6 Ê Lens 11 6 phakic pseudophakic Ê Visual acuity 0.125 – 0.6 (0.4) Ê mild NPDR 2 Vitreomacular Traction Syndrome + Macular Hole preop 0.25 145 μm ED 64y female phakic ! ! JETREA ! ! ! ! ! preop 0.25 145 μm ED 64y female phakic ! ! JETREA ! ! ! ! day 28 0.5 ! ! ! ! ! ! ! ! ! ! day 79 0.6 ! preop 0.25 260 μm HB 74y female pseudophakic ! ! preop 0.25 260 μm HB 74y female pseudophakic ! ! ! ! ! day 1 0.25 ! ! preop 0.25 260 μm HB 74y female pseudophakic ! ! ! ! ! day 1 0.25 ! ! ! ! day 7 0.25 ! ! preop 0.25 260 μm HB 74y female pseudophakic ! ! ! ! ! day 1 0.25 ! ! ! ! day 7 0.25 ! ! ! ! day 21 0.3 ! ! preop 0.25 260 μm HB 74y female pseudophakic ! ! ! ! ! day 1 0.25 ! ! ! ! day 7 0.25 ! ! ! ! day 21 0.3 ! ! ! ! day 30 0.4 ! ! ! ! ! ! preop 0.25 260 μm HB 74y female pseudophakic ! ! ! ! ! day 1 0.25 ! ! ! ! day 7 0.25 ! ! ! ! day 21 0.3 ! ! ! ! day 30 0.4 ! ! ! ! day 70 0.4 6.5 months postop 0.4 preop 0.4 195 μm SU 60y female phakic ! ! ! ! ! ! ! preop 0.4 195 μm SU 60y female phakic ! ! ! ! ! ! ! ! ! ! day 1 0.4 ! ! ! ! ! ! ! preop 0.4 195 μm SU 60y female phakic ! ! ! ! ! ! ! ! ! ! day 1 0.4 ! ! ! ! ! ! ! ! ! day 34 0.4 preop 0.4 195 μm SU 60y female phakic ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! day 34 0.4 ! preop 0.2 185 μm HF 72y male phakic ! ! JETREA ! ! ! ! ! ! ! day 9 0.25 ! ! ! day 13 Phaco PPV ! ! ! ! ! ! day 16 0.16 ! ! ! ! 3 months 0.63 ! preop 0.25 275 μm ES 66y female phakic ! ! ! JETREA ! ! ! ! day 14 0.25 524 μm ! ! ! ! ! ! day 41 ! ! ! ! Phaco PPV ! day 51 0.25 ! ! ! 5 months 0.8 ! preop 0.25 WW 69y male phakic US: no PVD ! ! ! JETREA ! ! ! ! day 41 0.25 ! ! ! ! ! 3 months 0.2 ! ! ! ! ! Phaco PPV ! ! ! ! ! 4 months 0.25 ! ! Vitreomacular Traction Syndrome preop 0.5 HT 68y female pseudophakic ! ! ! ! ! preop 0.5 HT 68y female pseudophakic ! ! ! ! ! ! ! ! ! ! ! day 6 0.5 „much better“ ! day 19 0.8 preop 0.4 AB 62y female phakic ! ! JETREA ! ! ! ! preop 0.4 AB 62y female phakic ! JETREA ! ! ! ! ! day 26 ! ! ! ! ! 0.5 preop 0.4 AB 62y female phakic ! ! JETREA ! ! ! ! ! day 26 ! ! ! ! ! ! ! ! ! ! day 54 ! ! ! 0.5 0.4 5 months 0.6 no OCT preop 0,4 HVE 71y male phakic ! mild NPDR ! ! ! ! ! ! preop 0.4 HVE 71y male phakic ! mild NPDR ! JETREA ! ! ! ! ! ! ! day 1 0.5 ! ! ! ! ! ! ! ! ! day 49 1.0 preop 0.4 RL 83y male phakic ! ! JETREA ! ! ! ! ! day 1 0.4 ! ! ! ! ! ! ! day 25 0.4 ! ! ! ! ! ! day 76 0.4 ! 6 months 0.4 PPV recommended ! preop 0.2 BS 68y female phakic ! ! JETREA ! ! ! day 6 0.3 ! ! ! ! ! ! ! ! day 42 0.4 ! ! ! Phaco+PPV ! ! ! ! 3 months postop 0.4 ! ! preop 0.4 WG 73y female phakic ! JETREA ! ! ! ! ! ! day 1 0.4 ! ! ! ! ! ! ! ! day 6 0.5 ! ! ! ! ! ! ! ! day 41 0.4 ! preop 0.4 WG 73y female phakic ! JETREA ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! 1 months post Phaco PPV ! VA 0.8 ! ! ! ! ! preop 0.3 GS 78y female pseudophakic ! JETREA ! ! ! ! ! day 7 0.4 ! ! ! ! ! ! ! ! ! ! day 28 0.3 no change ! ! ! ! day 32 PPV ! 4 months 0.5 ! preop 0.5 GB 72y female phakic ! ! ! JETREA ! ! ! ! ! day 20 0.4 ! ! ! ! ! ! day 56 0.4 ! ! ! ! ! PPV recommended ! preop 0.25 PB 92y male pseudophakic ! ! ! JETREA ! ! ! ! ! ! day 12 0.32 ! ! ! ! ! ! 4.5 months 0.4 ! ! no OCT: resolution? ! wishes no further treatment ! preop 0.5 KM 77y male phakic ! ! ! JETREA ! ! ! ! ! ! ! ! day 1 0.4 ! ! ! ! ! ! ! ! day 28 0.6 ! ! ! ! preop 0.6 HS 78y female pseudophakic ! ! ! ! ! ! JETREA ! ! ! ! ! ! ! ! ! day 7 0.4 ! ! 2 months PPV ! ! ! ! ! day 2 post PPV 0.05 ! ! Jetrea : First Experience Ê Follow up (17 / 18): 20– 180 d (90) Ê resolution of VMT Ê yes 2/11 18% Ê no PVD, better VA 1/11 9% Ê questionable release 1/11 9% Ê no 7/11 PPV 4 Ê MH closed ? Ê yes 2/6 33% Ê no 4/6 PPV 4 Jetrea : First Experience ! Ê „success rate“ 6 / 17 35% ! Ê costs for drug: n = 17 63.364,14 € ! Ê costs for each success 10561 € Jetrea in Frankfurt ! Ê success lower than in the studies ! Ê small group with short follow-‐up! ! Ê did not inject deep into the vitreous Ê did not wait long enough until patient got up? Conclusion ! Ê high costs of Jetrea Ê best indication for Jetrea: Ê younger patient with clear lens and small FTMH Ê PPV +-‐ Phaco: Ê patient with coexisting cataract and longer history and / or pseudocysts in OCT Caution ! Ê High myopia was among exclusion criterias for studies Ê risks of nonsurgical PVD remain unclear SW 40y female phakic ! high myopia ! AXL 28 mm ! VMTS and FTMH ! Jetrea elsewhere ! ! ! ! ! ! SW 40y female phakic ! high myopia ! AXL 28 mm ! VMTS and FTMH ! Jetrea elsewhere ! ! ! ! ! ! ! day 8 RD due to FTMH PPV and silicone oil elsewhere ! ! MH: 1288 μm ! ! Shukran ! Thank You Very Much
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