Levy imt mda_symposium_oct2013
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The implantable miniature telescope offers hope for patients with dry macular degeneration
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Levy imt mda_symposium_oct2013
- 1. Implantable Telescope: Is it for me? October 12, 2013 Macular Degeneration Association Educational Symposium Marc H. Levy, MD Sarasota Retina Institute 1
- 2. Financial Disclosures • IMT-002 Clinical Trial . . . Principal Investigator/Surgeon • IMT-PAS-01 Clinical Trial . . . Principal Investigator/Surgeon VisionCare™ / CentraSight™ • VisionCare is the only company to manufacture an implantable miniature telescope. • CentraSight™ is the treatment program for patients considering, screening, and undergoing surgery for the implantable miniature telescope. 2
- 3. Overview I. Treatment Status Today II. Technology & Clinical Outcomes III. Treatment Program 3
- 5. Medicare Coverage 2011 – 2012 FLORIDA – FIRST COAST SERVICE OPTIONS FLORIDA – FIRST COAST SERVICE OPTIONS Local Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) Local Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) (L32822) (L32822) EFFECTIVE OCTOBER 2012 EFFECTIVE OCTOBER 2012 After consideration of comments received from various experts in the field, and in After consideration of comments received from various experts in the field, and in order to give access to care to beneficiaries who may otherwise not have any other order to give access to care to beneficiaries who may otherwise not have any other treatment options, limited coverage will be allowed for patients with untreatable endtreatment options, limited coverage will be allowed for patients with untreatable endstage age-related macular degeneration who meet all of the indications… stage age-related macular degeneration who meet all of the indications… 5
- 6. American Academy of Ophthalmology 6
- 7. Medicare Advantage Plans • Policies beginning to initiate: 7 Source: FDA Professional Use Information labeling
- 9. End-Stage AMD Profoundly Reduces Function/Quality of Life Functional Daily Living Social 9
- 11. Field of View – External Telescope 11
- 12. Inside Eye = LARGER Field of View 12
- 13. New Category Device and Procedure • Medical Device: the telescope is entirely different from an IOL treats AMD (and not cataract) • Procedure: Implanting the telescope is entirely different from inserting an IOL 13
- 14. Mechanism of Action Scarred Macula Telescope Implant Central Visual Field Projection (Natural Lens/IOL) Central Visual Field Projection CAT 14 CAT
- 15. Implantation Technique • No new equipment • Device is not an IOL • 12 mm limbal incision & large capsulorrhexis • Posterior direction and OVDs critical to avoid corneal touch 15
- 17. 6 Weeks Postoperative Postoperative Appearance (6 weeks) James P. Gilman, CRA
- 18. Patient Capabilities Telescope Eye = Central Vision Distance: Recognizing faces, watching TV, seeing store signage Near: Reading, playing cards, dining Retains scanning capability Other Eye = Peripheral Vision Allows orientation and safe mobility 18
- 19. FDA Pivotal Trial: 28-Centers 19
- 20. Phase II/III IMT002 Trial (2002 – 2004) • Prospective, 28 US centers • Multi-disciplinary approach – “Vision training” 6 visits over first 3 months • 217 visually impaired patients enrolled – Mean Age 76 years – Mean BCVA 20/316 (range: 20/80 – 20/800) • Follow-Up – 12 months: n=194 of 206 implanted IOL instead of telescope prosthesis) (11 received – 24 months: n=174 of 206 implanted 20
- 21. One-Year Results Summary Efficacy • FDA VA endpoint met – 90% ≥ 2 lines vs. 50% required • 67% improved ≥ 3 lines BCDVA – vs. 10% of control fellow eyes (p<.0001) • Improved quality of life – VFQ increase 7-14 points (relevant subscales) Safety • Preservation of vision: 95% • Endothelial cell density >17% target • Implant well tolerated in eye 21
- 22. IMT Restores Functional Sight in Blind Patients (5-year follow-up data) • Pre-IMT vision of 20/320 or worse (statutory blindness) • Significant & sustained improvements in vision (long-term) FDA Summary of Safety and Effectiveness Data BCDVA = Best-Corrected Distance Visual Acuity 22
- 23. Large, Clinically Significant Visual Gain Intraocular lenses (IOLs) for cataract do not work for End-Stage AMD Control 23
- 24. IMT Fulfills Unmet Daily Living & Quality of Life Need for Blind Patients Mean National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Score Change VFQ Score Change from Baseline Benefits across both Functional and Psychosocial Domains 5-point changes are considered clinically meaningful Source: Hudson, HL, et al. Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration: 1-Year Results. Ophthalmology. November, 2006. 113 (11) 1987-2001. 24
- 25. Basis of CentraSight Program 25
- 27. Pre-Op Candidacy Assessment Template 1 2 3 Retina Low Anterior •Diagnosis •Refer Vision Optom OT/Other •Low Vision Eval •Functional Goals •Eye Selection •Rehab Potential Segment • Cornea health •AC depth, other 27
- 28. Post-Op Management Post-Op Low Vision Qualified Candidate s Po U pF tO Anterior Segment Telescope Implantation 6o r1 2m os FU V is it Retina 28
- 29. FLORIDA FIRST PATIENT DONE! February 4, 2013 81 y.o. white female with Advanced dry ARMD OU Sarasota Memorial Hospital Cape Surgery Center 29
- 36. CURRENT STATUS IMT Sarasota Memorial Hospital 2013 • 6 patients implanted since February 2013 • 4 “in the wings” Patient #1 LV – Preop Va: 20/300 – Postop Va: 20/70 • “I can now read” 36 Source: FDA Professional Use Information labeling
- 37. CentraSight™ Program Painting by IMT002 Study Patient 37
Hinweis der Redaktion
- {"16":"Attention should be paid to the following surgical considerations:\nProper incision construction. \nA capsulorhexis of 7 mm. This allows easier positioning of the device into the capsular bag because of the slightly stiffer haptics of this lens.\nAppropriate OVD use to coat the endothelium and deepen the chamber. \nLifting the cornea without folding/tenting and inserting device at 45 degree angle to minimize risk of corneal touch.\nMinimizing intraocular instrument manipulation.\nPlacing the loops in the capsular bag, rotating the haptics to 12 and 6 o’clock.\nCareful attention to wound integrity to maintain anterior chamber. \n","11":"Here is the field of view of a wide field external telescope. How much visual information do we have? What are we looking at?\n","12":"Implantable telescope field of view has 4X the area of an external telescope. Simply put, you can see more in the visual field. Here you could see you are looking at a fire station somewhere in the US and the weather is nice. Not so with the external telescope field of view in a static gaze. \n","18":"1. Patients Use… BOLD ONLY and highlight DIST & NEAR\n2. Cosmetic appearance\n","19":"Trial sites – many post-FDA approval centers\n","36":"FURTHER BREAKOUT COMPLICATIONS \nFDA approval included 5-years of safety follow up\nInflammatory deposits\nAgain, Corneal decomp is the most significant risk (5 cases): truest measure of corneal health, and treatments availablek\nExplants: note Stargardt’s contraindicated on FDA label due to small sample and explant rate.\nFYI: Other = 2 device failures and 2 cornea transplants with device removal\nNo retina issues >1% – no retinal detachments, only 1 occurrence of CNV, 1 PCO treated by pars plana capsulotomy \nThe fundus with a 90D lens and by diagnostics such as UBM\n","25":"Explain program is MULTIDISCIPLINARY based on learning from our trial and investigator experience\nPut together by clinical investigators, visual scientists, and VisionCare; some information has been published in the literature.\n","14":"MOA TWO WAYS TO DESCRIBE IT\nFirst – magnifying image so effective size of scotoma appears smaller\n","20":"Did not have in the protocol the formalized visual rehabilitation program we will have in this trial. Only had 13 patients in the Phase I trial, so did not have the experiences to develop a formalized program for IMT002. \n","37":"TO CONCLUDE: \n1. CAN BE LIFE CHANGING IN APPROPRIATE SELECTED PTS --- VCOT LOOKING FORWARD TO WORKING WITH YOU.\n","26":"Main areas and suggested sequence of the preop screening for proper pt selection\nReferrals come from: retina clinic, low vision clinic, public awareness program, ophthalmic community, other.\n","15":"No new capital equip, difference is technique\n"}