levy imt mda_symposium_oct2013
DESCRIPTION
The implantable miniature telescope offers hope for patients with dry macular degenerationTRANSCRIPT
Implantable Telescope:Implantable Telescope:Is it for me?Is it for me?
October 12, 2013October 12, 2013Macular Degeneration Association Educational SymposiumMacular Degeneration Association Educational Symposium
Marc H. Levy, MDMarc H. Levy, MD
Sarasota Retina InstituteSarasota Retina Institute
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Financial Disclosures
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• 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.
I. Treatment Status Today
II. Technology & Clinical Outcomes
III. Treatment Program
Overview
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FDA Approved: 2009
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Medicare Coverage 2011 – 2012
FLORIDA – FIRST COAST SERVICE OPTIONSLocal Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) (L32822)EFFECTIVE OCTOBER 2012
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 treatment options, limited coverage will be allowed for patients with untreatable end-stage age-related macular degeneration who meet all of the indications…
FLORIDA – FIRST COAST SERVICE OPTIONSLocal Coverage Determination (LCD) for Implantable Miniature Telescope (IMT) (L32822)EFFECTIVE OCTOBER 2012
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 treatment options, limited coverage will be allowed for patients with untreatable end-stage age-related macular degeneration who meet all of the indications…
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American Academy of Ophthalmology
Source: FDA Professional Use Information labeling
• Policies beginning to initiate:
Medicare Advantage Plans
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Most Recent Publication
Functional Daily Living Social
End-Stage AMDProfoundly Reduces
Function/Quality of Life
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Simulations at Distance/Near
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Field of View – External Telescope
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Inside Eye = LARGER Field of View
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
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Scarred MaculaCentral Visual Field Projection (Natural Lens/IOL)
CAT CAT
Telescope ImplantCentral Visual Field Projection
Mechanism of Action
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Implantation Technique
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• No new equipment
• Device is not an IOL
• 12 mm limbal incision & large capsulorrhexis
• Posterior direction and OVDs critical to avoid corneal touch
Postoperative Appearance (6 weeks)
James P. Gilman, CRA
6 Weeks Postoperative
Telescope Eye = Central VisionDistance: Recognizing faces, watching TV, seeing
store signage Near: Reading, playing cards, dining
Retains scanning capability
Other Eye = Peripheral VisionAllows orientation and safe mobility
Telescope Eye = Central VisionDistance: Recognizing faces, watching TV, seeing
store signage Near: Reading, playing cards, dining
Retains scanning capability
Other Eye = Peripheral VisionAllows orientation and safe mobility
Patient Capabilities
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FDA Pivotal Trial: 28-Centers
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• 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 (11
received IOL instead of telescope prosthesis)– 24 months: n=174 of 206 implanted
Phase II/III IMT002 Trial(2002 – 2004)
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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
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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 Acuity22
Large, Clinically Significant Visual Gain
Intraocular lenses (IOLs) for cataract do not work for End-Stage AMD
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Control
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.
5-point changes are considered clinically meaningful
VFQ
Sco
re C
hang
e fr
om B
asel
ine
IMT Fulfills Unmet Daily Living & Quality of Life Need for Blind Patients
Mean National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Score Change
Benefits across both Functional and Psychosocial Domains
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Basis of CentraSight Program
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Treatment ModelTreatment Model
End-Stage
AMD Patient
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Retina
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Anterior
Segment
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Low
Vision26
Pre-Op Candidacy AssessmentTemplate
•Diagnosis
•Refer
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Retina
• Cornea health
•AC depth, other
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Anterior
SegmentOT/Other
•Functional Goals
•Rehab Potential
Optom
•Low Vision Eval
•Eye Selection
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Low
Vision
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6 or 12 mos FU VisitRetina
Post Op FU
Anterior Segment
Post-Op
Low Vision
Qualified Candidate
Telescope
Implantation
Post-Op Management
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FIRST PATIENT DONE!FIRST PATIENT DONE!February 4, 2013February 4, 2013
81 y.o. white female with81 y.o. white female withAdvanced dry ARMD OUAdvanced dry ARMD OU
Sarasota Memorial HospitalSarasota Memorial HospitalCape Surgery CenterCape Surgery Center
FLORIDA
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POST-OP DAY #1POST-OP DAY #1
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POST-OP DAY #1POST-OP DAY #1
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POST-OP DAY #1POST-OP DAY #1
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POST-OP DAY #1POST-OP DAY #1
6 weeks post-operative
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6 weeks post-operative
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Source: FDA Professional Use Information labeling
• 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”
CURRENT STATUS IMTSarasota Memorial Hospital 2013
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CentraSight™ Program
Painting by IMT002 Study Patient