financial disclosure diabetic retinopatathy - diabetic retinopathy monterey 2017 ho.pdf · diabetic...

1

Jay M. Haynie, OD, FAAO

Executive Clinical Director – Retina and Macula Specialists

Diabetic RetinopatathyFinancial Disclosure

I have received honoraria or am on the advisory board for the following companies:

Carl Zeiss Meditec Advanced Ocular

Arctic DX – Macula Risk Care

Genentech USA – USMA Lampa Advisory

Diabetic Retinopathy Diabetic Retinopathy

Jan. 28, 2008 -- The number of older Americans

diagnosed with diabetes grew by nearly a quarter in

the last decade, a rate that experts say threatens not

only the health of the elderly but the viability of the

nation's health care system.

Type 2 diabetes is the most prevalent form of the

disease, accounting for 90 to 95% of all diabetes cases

in America AND is largely preventable according to

the CDC.

Diabetic Retinopathy

Although the vast majority of individuals with type 2

diabetes are adults, children and adolescents are

increasingly at risk for the disease due to growing

childhood weight problems and sedentary lifestyles.

http://diabetes.webmd.com/default.htm

http://www.dlife.com/dLife/do/ShowContent/daily_living/adults/

http://www.dlife.com/dLife/do/ShowContent/daily_living/kids/index.html

2


Research suggests that 1 out of 3 adults has

prediabetes. Of this group, 9 out of 10 don't know

they have it.

29.1 million people in the United States have diabetes,

but 8.1 million may be undiagnosed and unaware of

their condition.

About 1.4 million new cases of diabetes are diagnosed

in United States every year.


More than one in every 10 adults who are 20 years or

older has diabetes. For seniors (65 years and older),

that figure rises to more than one in four.

Cases of diagnosed diabetes cost the United States an

estimated $245 billion in 2012. This cost is expected

to rise with the increasing diagnoses.


The International Diabetes Federation reports that

more than 400 million people were living with

diabetes as of 2015. Prior estimations predicted 300

million by 2025.

Either you have it or you don’t.

That's the message that the American Diabetes

Association (ADA) is driving home to millions of

people who believe they may be "borderline diabetic,"

or that their "sugar is just a bit high."

What is diabetes?

DM is a chronic disorder characterized by a

lack of insulin or increased resistance to

insulin

Insulin is needed for proper uptake of

glucose

Clinical result is hyperglycemia

retinopathy

nephropathy

neuropathy

Diabetes: Magnitude of Complications

Diabetic

Retinopathy

Leading cause

of blindness

in working age

adults

Diabetic

Neuropathy

Leading cause of non-traumatic

lower extremity amputations

Diabetic

Nephropathy

Leading cause of

end-stage renal disease

Stroke

Cardiovascular

Disease

2- to 4- fold increase in cardiovascular mortality and stroke

Obesity Trends* Among U.S. Adults

BRFSS, 1994(*BMI ≥30, or ~ 30 lbs overweight for 5’ 4” person)

No Data <10% 10%–14% 15%–19% 20%–24% ≥25%

https://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html

http://www.idf.org/WDD15-guide/facts-and-figures.html

3

New Diagnosis Criteria

Panel of “experts” at ADA annual meeting are recommending A1C be used for diagnosis of diabetes

Glycosolated hemoglobin

Tells blood sugar control over 3 months

normal range 4% to 6%

HgbA1c BS Level HgbA1c BS Level

4 60 9 210

5 90 10 240

6 120 11 270

7 150 12 300

8 180 13 330

What do the results of the Hemoglobin A1c

mean….?

What do the results of the Hemoglobin A1c

mean….?Diabetic Retinopathy

What is our role??

4


- Classification of Diabetic Retinopathy:

Non Proliferative Diabetic Retinopathy

Mild

Moderate

Severe

Very Severe

Proliferative Diabetic Retinopathy



H/MA – hemorrhage or microaneurysm

VB – venous beading

IRMA – intraretinal microvascular abnormalities

NEO - neovascularization



Mild Non Proliferative Diabetic Retinopathy

At least one microaneurysm

Characteristics not met for more severe

retinopathy


OCT Angiography (OCTA)



Moderate Non Proliferative Diabetic Retinopathy

H/MA greater than standard photograph No. 2A and/or

Cotton wool spots, VB, or IRMA present

Characteristics not met for more severe retinopathy

5



Severe Non Proliferative Diabetic Retinopathy

H/MA greater than standard photograph No. 2A in 4

quadrants or

VB in 2 or more quadrants or

IRMA greater than standard photograph No. 8A in at least 1

quadrant

4 – 2 – 1 RULE

Characteristics not met for more severe retinopathy



Very Severe Non Proliferative Diabetic Retinopathy

Two or more criteria of Severe NPDR

No frank neovascularization



H/MA’s in 4 quadrants = Severe Non PDR

6



IRMA in 2 quadrants = Severe Non PDR



H/MA’s in 4 quadrants = Severe Non PDR

IRMA in 2 quadrants = Severe Non PDR


Rate of Progression to PDR

1 year 3 years

Mild NPDR 5 % 14%

Moderate NPDR 12-26 30-48

Severe NPDR 52 71




Neovascularization of the disc (NVD)

< Standard photo 10A (<0.25 – 0.33 disc area)

Neovascularization elsewhere in the retina (NVE)

without associated vitreous or pre-retinal

hemorrhage


Treatment: Clinically Significant Macular Edema

Laser Photocoagulation is recommended

for patients who meet criteria for CSME

regardless of visual acuity.

Laser Photocoagulation reduces the risk

for moderate vision loss by 50%.

Moderate vision loss is doubling the

visual angle.

7


Treatment: Clinically Significant Macular Edema

Despite the guidelines for treatment of

CSME with laser photocoagulation,

many patients are treated with intravitreal

agents such as Avastin, Lucentis,

Triesence and Eylea initially.

Diabetic Macular Edema:

Approved Pharmacologic Treatment Lucentis (Ranibizumab)

Eylea (Aflibercept)


Approved Pharmacologic Treatment Ozurdex (Dexamethasone Intravitreal Implant)


FUTURE: Pharmacologic Treatment Iluvien (Fluocinolone Acetonide Implant)

36 month duration

80 % cataract

35% elevated IOP greater

than 10mmHg (5% require

glaucoma surgery)


Treatment: Diabetic Macular Edema (antiVEGF)Comparative Effectiveness Study

of Intravitreal Aflibercept,

Bevacizumab, and Ranibizumab

for Diabetic Macular Edema

(Protocol T)

8

Protocol T

Ranibizimab was the first approved anti VEGF

treatment option for diabetic macular edema

(DME) and studies have shown it to be safe and

efficacious and superior to focal/grid laser alone

for patients with center involved DME.

A concern is the cost per dose of ranibizumab and

the need for multiple treatments over time.

Protocol T

Is there an alternative anti VEGF agent that might

prove to be as efficacious, deliver equal or longer

acting effects and cost substantially less.

Bevacizumab and Afliberacept are the other

options available for comparison.

660 adults in 89 clinical sites

Protocol T

- Ranibizumab 0.3 mg every 4weeks at baseline

and up to every 4 weeks using defined re

treatment criteria

- Bevacizumab 1.25 mg every 4weeks at baseline


treatment criteria

- Afliberacept 2.0 mg every 4weeks at baseline


treatment criteria

Protocol T

Primary Outcome Measures:

Overall change in visual acuity measured at 1 year

Change in VA measured from baseline to 1 year

Baseline VA letter score <69 (20/50 or worse)

Change in VA measured from baseline to 1 year

Baseline VA letter score 78-69 (20/30 – 20/40)

Protocol T

Secondary Outcome Measures: (at 1 year)

Overall change in OCT central subfield thickness

Change in OCT central subfield thickness from

baseline to 1 year

Baseline VA letter score <69

Change in OCT central subfield thickness from

baseline to 1 year

Baseline VA letter score 78-69

Protocol T

Secondary Outcome Measures:

Overall change in retinal volume

Total number of injections prior to one year

Total number of laser treatments

Eyes receiving 1 or more alternative treatments for

DME other than laser

9

Protocol T

Results:

Year 1 – all three anti VEGF compounds

improved acuity, on average, in patients with

baseline acuity of 20/40 to 20/32 but Afliberacept

was superior when baseline acuity was 20/50 or

worse.

Mean Change in Visual Acuity Letter Score

Baseline Visual Acuity 20/32 to 20/40

0

2

4

6

8

10

12

14

16

18

20

0 4 8 12 16 20 24 28 32 36 40 44 48 52

ME

AN

CH

AN

GE

IN

VIS

UA

L A

CU

ITY

LE

TT

ER

SC

OR

E

WEEKS

Aflibercept Bevacizumab Ranibizumab

~+ 8

~50% of Cohort

Mean Change in Visual Acuity Letter Score

Baseline Visual Acuity 20/50 or Worse

0

2

4

6

8

10

12

14

16

18

20

0 4 8 12 16 20 24 28 32 36 40 44 48 52

ME

AN

CH

AN

GE

IN

VIS

UA

L A

CU

ITY

LE

TT

ER

S

CO

RE

WEEKS


* P-values adjusted for baseline visual acuity and multiple comparisons

+19

+14

+12

~ 50% of Cohort

Protocol T

Results:

Year 2 – improved vision was again noted in all 3

groups with an average of half of the number of

injections, decreased frequency of visits and a

decrease in the need for focal/grid laser treatment.

Mean Change in Visual Acuity Over 2 Years

Full Cohort

* P-values adjusted for baseline visual acuity and multiple comparisons

0

2

4

6

8

10

12

14

16

18

20

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104

ME

AN

CH

AN

GE

IN

VIS

UA

L A

CU

ITY

LE

TT

ER

S

CO

RE

WEEKS


+13.3

+11.2

+9.7 +10.0

+12.3

+12.8

Mean Change in Visual Acuity Over 2 Years

Baseline Visual Acuity 20/50 or Worse

* P-values adjusted for baseline visual acuity and multiple comparisons 0

2

4

6

8

10

12

14

16

18

20

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104

ME

AN

CH

AN

GE

IN

VIS

UA

L A

CU

ITY

LE

TT

ER

SC

OR

E

WEEKS


+18.9

+14.2

+11.8

+13.3

+16.1

+18.1~50% of

Cohort

10

New description

CSME has now been further characterized

Center involved edema

Non center involved edema


Center Involved Macular Edema


Clinical Trials

Non - Center Involved Macular Edema


Clinical Trials Diabetic Retinopathy

Treatment: Proliferative Diabetic Retinopathy

The Diabetic Retinopathy Study showed

that scatter laser PRP reduced the

incidence of severe vision loss by up to

50 % in patients with Proliferative

Diabetic Retinopathy.

Severe vision loss is < 5/200





11



INSERT CLARUS IMAGE HERE OF PRP


Proliferative Diabetic Retinopathy - OCTA

AngioPlex VRI slice confirms neovascularization (NVE)

55 year old man with Type I Diabetes

AngioPlex / FA images showing neovascularization (NVE)

as well as the enlarged FAZ

55 year old man with Type I Diabetes


Proliferative Diabetic Retinopathy - OCTA


Even with treatment and resolution of macular

edema some patients continue to have severe vision

loss….. Driven by ischemia!

12


OCT angiography – Zeiss AngioPlex


Combination therapy has become standard for the

treatment of diabetic retinopathy.

Prolferative Retinopathy with marked non perfusion and NVE 1 Month status post AVASTIN with panretinal laser treatment.

3 Months status post AVASTIN with panretinal laser treatment.

Vitreous Hemorrhage and Traction Retinal

Detachments

Despite best efforts to manage complications of

diabetes in the office some patients require

surgical intervention with Vitrectomy.


13

Vitreous Hemorrhage and Traction Retinal

Detachments



Traction Retinal Detachment

1 month s/p silicone oil

Prompt Panretinal

Photocoagulation Versus

Ranibizumab+Deferred

Panretinal Photocoagulation for

Proliferative Diabetic

Retinopathy (Protocol S)

Ptotocol S

Randomized Clinical Trial evaluated noninferiority of

ranibizumab vs. panretinal photocoagulation (PRP)

with a primary endpoint of mean change in visual

acuity from baseline to 2 years.

203 eyes randomized to receive PRP

191 eyes received 0.5mg intravitreous ranibizumab at

baseline and every 4 weeks based on re treatment

protocol

14

Protocol S

2 Year results: Visual acuity improvement

PRP group – improvement in 0.2 letters

0.5 mg ranibizumab group – 2.8 letters

Protocol S

2 Year results: Peripheral VF loss and Vitrectomy

PRP group – 531 dB loss and 15% needed surgery

0.5 mg ranibizumab group – 213 dB loss and 4 %

Ranibizumab

Approved in 2017 to treat ALL levels of Diabetic

Retinopathy

Will this change what we do for patients with a

chronic diabetic eye disease?

Is it the right thing to do?

Type I Diabetes with Proliferative Retinopathy

PRP laser treatment in 1990


PRP laser treatment in 1990 - OCTA



15



Although clinical trials have defined the standard

of care for management of CSME and

PDR…..intravitreal agents like

Avastin/Lucentis, Eylea and Steroids have

rapidly become adjuncts to laser treatment

and prior to Vitrectomy surgery.

Avastin has also become a crucial component in

the management of neovascular glaucoma by

inducing regression of rubeosis within a few

days.



Non Proliferative Diabetic Retinopathy

Mild NPDR – follow yearly

Moderate NPDR – follow q6 – 12 months

Severe NPDR – follow q4 - 6 months / REFER?

Very Severe NPDR – follow q3 months / REFER?

** Consider patient control of diabetes

** Consider success of therapy

** Consider risks for progression to PDR

** Consider personal comfort level

Referral Criteria:



- Prompt referral for pan retinal photocoagulation

based of the guidelines of the DRS.

- If rubeosis is present Avastin + PRP should be

initiated within 48 – 72 hours to prevent

neovascular glaucoma.

Referral Criteria:


Diabetic Macular Edema

- Follow the guidelines of the ETDRS when

considering the referral ??

- Most retina surgeons will treat “center involved”

diabetic macular edema

Referral Criteria:


Referral Criteria:

Diabetic Macular Edema

Center versus non center involved edema…..

16

[email protected]

financial disclosure diabetic retinopatathy - diabetic retinopathy monterey 2017 ho.pdf · diabetic...

Documents