Modern Pharmacologic Treatment Of Macular Disorders Choroidal Neovascularization & Macular Edema Treatment in the 21 st Century
C ustom -D esigned A pproach to T reatment with A lgorithms
Nabil M. Jabbour, M.D., F.A.C.S. Clinical Professor of Ophthalmology , West Virginia University President , Mid-Atlantic Retina Consult. & ForSight Foundation Chairman , Light of the World Hospital Association & Nour Misr, IPROF program & FEBI project nnjabbour@gmail.com
Choroidal Neovascularization & Macular Edema Treatment in the 21 st Century The Pharmacologic Revolution
The Good: New and Effective Ways for Treatment The Bad: Expensive, Repetitive and Frustrating The Ugly: Total Chaos Translating Multicenter Clinical Studies to Real Life…
THE GOOD Not only one but three anti-VEGFs to choose from Not only one but four steroids to choose from And the list is growing…
THE BAD Which one to start with? When to switch?
THE UGLY What is the n? (number of “loading” doses) What is the PRN? (How often do we repeat?) Protocols versus Algorithms
Protocols versus Algorithms Treatment Approach Ease of Use Simple Rather Complex Application Better for Clinical Studies Better for Real Life
Applying the Clinical Study Protocols In Real Life Resulted In Overtreatment when the protocol was adhered to… Under-treatment when the protocol was modified into another arbitrary protocol!
TREATMENT PROTOCOLS ARE BLIND TO THE MOST IMPORTANT FACTOR THAT SHOULD GUIDE TREATMENT: RESPONSE!
RESPONSE Theoretical Considerations Following an intravitreal injection, the condition will: Resolve Improve Partially Not Change Worsen
TREATMENT Theoretical Considerations Logic dictates that in RESPONSE to Full Resolution Withhold additional treatment Partial Resolution Repeat same treatment No Change - Consider repeating and/or augmenting treatment - Consider switching treatment Worsening Switch treatment
PROTOCOLS ( Preset Treatment, Doses & Intervals ) Result In: Repeating treatment where not indicated Withholding treatment where indicated Missing critical times for switching ALL of which evens out in clinical studies but results in less impressive outcomes in real life…
Applying the Clinical Study Protocols In Real Life Resulted In
CUSTOM-DESIGNED APPROACH
Custom-Designed Approach Theoretical Considerations Individualized TREATMENT based on Individualized RESPONSE Results in more timely & effective delivery Avoids over and under treatment
PROTOCOLS For Choroidal Neovascularization & Macular Edema Treatment FDA - motivated Multicenter Studies (original protocols) Relief - motivated Multicenter Studies (modified protocols)
ORIGINAL PROTOCOLS Choroidal Neovascularization Macular Edema DME VO
MODIFIED PROTOCOLS Choroidal Neovascularization Macular Edema DME VO
C ustom- D esigned A pproach to T reatment with A lgorithms
CNV Algorithm ME Algorithm
CNV Algorithm
ANATOMIC RESPONSE SCALE
VISUAL RESPONSE SCALE V 0 V + V - ≥ 2 Letter 0 or 1 Letter ≥ 2 Letter Loss Loss or Gain Gain
CNV Algorithm ME Algorithm
ME Algorithm
Full response Partial response *If both cystic and diffuse, start with injections PL = Preference List
Choroidal Neovascularization Macular Edema DME VOME
Choroidal Neovascularization Macular Edema DME VOME
Choroidal Neovascularization Macular Edema DME VOME
Choroidal Neovascularization Macular Edema DME VOME
CNV RESULTS 40% 47% 13% 168 CNVM 3 treatments/year Average improvement of 12 letters Improved Worsened DME 80 DME 33% 44% 3 treatments/year 23% Average improvement of 18 letters Improved Worsened Stable 38 ME 2° Vein Occlusion (VOME) ME Secondary to Vein Occlusion 5 treatments/year 17% Average improvement of 18 letters 18% 67% Minimum 24 months follow-up Improved Worsened Stable
Choroidal Neovascularization Macular Edema DME VOME CUMULATIVE COMPARISON
CUMULATIVE COMPARISON
Results Graph 1 : Eyes treated based on C-DATA algorithm improved better (higher Δ V) than those treated according to regimented protocols .
Results Graph 2 : Eyes treated based on C-DATA algorithm required less number of treatments per year (N) compared to those treated according to regimented protocols.
Results Mean follow-up period: (N= 53) 34.7 months Mean number of different types of Percentage of eyes with improved, treatments administered per year unchanged or worsened vision • Average improvement: 22.83 letters based on C-DATA • Average worsening: 9.55 letters
ALGORITHMS Dynamic modifications: Evidence-based Complex
ALGORITHMS Made More User Friendly By C-DATA Mobile App For I-Phone, Samsung and I-Pads
C ustom- D esigned A pproach to T reatment with A lgorithms App The C-DATA app is a digital guide to pharmacologic treatment of 3 macular disorders: Choroidal Neovascularization (CNV), Diabetic Macular Edema (DME) and Macular Edema Secondary to Vein Occlusion (VOME). The algorithms are built on evidence-based data from clinical studies. Treatment decisions and follow up recommendations are custom-designed based on easily measurable responses to treatment, rather than pre-set “cookie-cutter” protocols. Using this approach has resulted in better outcomes, less treatments and better patient compliance.
Q. What are the requirements for using this app? • Currently, the application is available for only CNV on Android phones, but we are working to release the iPhone version as soon as possible, as well as the two ME algorithms for both venues. Q. How does it work? • Definition of Terms Setting Up the Profiles & Entering Data (Tutorial) Pathway to Algorithm (In The Background)
How does it work? Definition of Terms TUTORIAL Pathway to Algorithm
How does it work? Definition of Terms TUTORIAL Pathway to Algorithm
DEFINITION OF TERMS CNV = Active Choroidal Neovascularization ME = Active Macular Edema ANATOMIC RESPONSE CNV ME VISUAL RESPONSE
ANATOMIC RESPONSE FIRST OCT AFTER TREATMENT CNV R0 = Negative (growth) to 14% regression R1 = 15-49% regression R2 = 50-69% regression R3 = 70-89% regression R4 = 90-100% regression
ANATOMIC RESPONSE SCALE
ANATOMIC RESPONSE FIRST OCT AFTER TREATMENT ME OCT Response ( R ) FULL response PARTIAL response NO response
ANATOMIC RESPONSE SCALE OCTs AFTER NO TREATMENT Rr = Continued regression Rm = Minimal recurrence Rd = Definite recurrence
VISUAL RESPONSE SCALE V- = Worsened V0 = Same V+ = Improved
VISUAL RESPONSE SCALE V 0 V + V - ≥ 2 Letter 0 or 1 Letter ≥ 2 Letter Loss Loss or Gain Gain
How does it work? Definition of Terms TUTORIAL Pathway to Algorithm
T U T O R I A L Setting Up the Doctor’s Profile (Once / Dr.) Setting Up the Patient’s Profile (Once / Pt.) Entering Patient’s Information (Once / Visit)
SETTING UP THE DOCTOR’S PROFILE ONE TIME Doctor’s Name Password Date Treatment Preference List (PL)
SETTING UP THE DOCTOR’S PROFILE TREATMENT PREFERENCE LIST (PL) Pick some or all of the agents below and rank them in descending order (1 st to last) Make a different list for: CNV – DME - VOME Avastin (A) Dexamethasone (Dx) Eylea (E) Lucentis (L) – 0.5 Lucentis (L) – 0.3 Ozurdex (O) Triamcinolone Acetonide (TA) Other agents &/or combination can be added / taken away at any time
SETTING UP THE PATIENT’S PROFILE ONE TIME Active CNV or ME
ENTERING PATIENT’S INFORMATION PER VISIT Enter “R” Enter “V” That’s ALL !!
How does it work? Definition of Terms TUTORIAL Pathway to Algorithm
PATHWAY To ALGORITHM (I n The Background) Active CNV New Patient Treatment naïve Go To Algorithm ( GTA ) Previously treated * No history available GTA ** History available: - Last Agent Used (date) • ≤ 4 weeks Move agent to bottom of PL, then GTA • > 4 weeks: - OCT and/or V/A change after treatment not available GTA - OCT and/or V/A worsened after treatment Move agent to bottom of PL, then GTA - OCT and/or V/A improved after treatment Move agent to top of PL, then GTA
PATHWAY To ALGORITHM (I n The Background) Active CNV Existing Patient Treatment naïve Go To Algorithm ( GTA ) Previously treated • Last agent Used * Good response Move agent to top of PL, then GTA ** Poor response Remove agent from PL, then GTA • Other Agents Previously Used * NO GTA ** YES - Good response Move to top of PL, then GTA - Poor response Move to the bottom of PL, then GTA
The App is a GUIDE… Not a Mandate!
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