Modern Pharmacologic Treatment Of Macular Disorders Choroidal - - PowerPoint PPT Presentation

Choroidal Neovascularization & Macular Edema

Treatment in the 21st Century

Modern Pharmacologic Treatment Of Macular Disorders

Custom-Designed Approach to Treatment with Algorithms

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 21st 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

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

TREATMENT

Theoretical Considerations

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

Custom-Designed Approach to Treatment with Algorithms

• CNV Algorithm
• ME Algorithm

• CNV Algorithm

ANATOMIC RESPONSE SCALE

V- V0 V+

≥ 2 Letter Loss 0 or 1 Letter Loss or Gain ≥ 2 Letter Gain

VISUAL RESPONSE SCALE

• CNV Algorithm
• ME Algorithm

• ME Algorithm

Full response Partial response

PL = Preference List *If both cystic and diffuse, start with injections

• Choroidal Neovascularization
• Macular Edema

 DME  VOME

• Choroidal Neovascularization
• Macular Edema

 DME  VOME

• Choroidal Neovascularization
• Macular Edema

 DME  VOME

• Choroidal Neovascularization
• Macular Edema

 DME  VOME

Minimum 24 months follow-up

47% 13% 40%

Improved Worsened

CNV

44% 23% 33%

Improved Worsened Stable

DME

67% 18% 17%

Improved Worsened Stable

ME Secondary to Vein Occlusion

RESULTS

 168 CNVM

• 3 treatments/year
• Average improvement of 12 letters

 80 DME

• 3 treatments/year
• Average improvement of 18 letters

 38 ME 2° Vein Occlusion (VOME)

• 5 treatments/year
• Average improvement of 18 letters

• Choroidal Neovascularization
• Macular Edema

 DME  VOME CUMULATIVE COMPARISON

CUMULATIVE COMPARISON

Graph 1: Eyes treated based on C-DATA algorithm improved better (higher ΔV) than those treated according to regimented protocols.

Results

Graph 2: Eyes treated based on C-DATA algorithm required less number

• f treatments per year (N) compared to those treated according to

regimented protocols.

Results

Mean number of different types of treatments administered per year based on C-DATA Percentage of eyes with improved, unchanged or worsened vision

• Average improvement: 22.83 letters
• Average worsening: 9.55 letters

(N= 53)

Mean follow-up period: 34.7 months

Results

ALGORITHMS

• Dynamic modifications: Evidence-based
• Complex

Made More User Friendly By

C-DATA Mobile App

For I-Phone, Samsung and I-Pads

ALGORITHMS

Custom-Designed Approach to Treatment with Algorithms

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

V- V0 V+

≥ 2 Letter Loss 0 or 1 Letter Loss or Gain ≥ 2 Letter Gain

VISUAL RESPONSE SCALE

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 (1st 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 (In 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 (In 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!

 C-DATA avoided over and under treatment  C-DATA was associated with excellent compliance (98% retention rate)  Mobile App Developed by John Fahd

• Simplifies using the algorithm
• Guide, not mandate
• Custom-designed per
• Physician
• Patient

 Demo (Please visit our web site eyecdata.com

• Samsung (available as of September 2015)
• iPhone and iPad (November 2015)

DISCUSSION

Treatment for CNV and ME can be custom-designed based on evidence-supported algorithms resulting in better visual outcomes, fewer treatments (less cost and side effects) and excellent patient compliance. The Algorithms and preference list will continue to be updated easily as more agents become available and more evidence is accumulated. The expansion of the App will continue to make this approach even more user friendly

CONCLUSION FUTURE

FUTURE IMPROVEMENTS

• More Data...
• User Input…
• Incorporated in next version