The Current Treatment Options for

DME , in Brief

Nawat watanachaiCMU

01, 2014

treatment options for DME

laser

laser+antiVEGF

antiVEGF

new comers

Laser treatment

80’s

ETDRS

focal/ grid laser to microaneurysms or area ofDME

laser + antiVEGF

DRCRnet

prospective trial

comparing standard laser to combination wit h Lucentis or steroid

VA : laser + Lucentis > laser alone

laser + antiVEGF

RESTORE trial

randomized control

VA : Lucentis/ Lucentis+laser > laser

1 yr : Lucentis(7inj) = Lucentis + laser

2 39yrs : Lucentis( . inj) = Lucentis( 35. inj) + laser

laser + antiVEGF

REVEAL

Asian population

similar to RESTORE

1at yr 1at yr Lucenti s

Lucentis+laser laserlaser

VA(ETDR

S letter)

5+ .5+ .99

5+ .5+ .77

1414

no of injection 7878 74.74. --

antiVEGF mono therapyLucentis

RISE and RIDE trials

- double masked, sham controlled, multicenttt

Lecentis monthly 0.3mg, 0.5mg, sham

24mths duration + additional Rx throug t ttt3 6

after 3 mtgs : rescue laser could apply

antiVEGF mono therapyLucentis

RISE

24mths24mths tttttttt 0.30.3 05. mg05. mg

ttttttt > 15 gain (%) 181181 448448 392392

tttttttt t (%) 1111 00 0808

antiVEGF mono therapyLucentis

RIDE

24mths24mths tttttttt 0.30.3 05. mg05. mg

ttttttt > 15 gain (%) 123123 336336 457457

tttttttt t (%) 123123 1616 1616

antiVEGF mono therapyLucentis

RISE and RIDE

24mths : macular laser procedures needed

sham1 .8 ,1 .6

l ucent i s 0308

RISE and RIDE

august 2012 : USFDA approved 0.3mg Lucentis f or DME Rx

antiVEGF mono therapyAvastin

tttt tttttt

125. mg Avastin VS laser

- - non ischemic center involving Ctt t

12mths : median VA (ETDRS let t er s)

8Avastin: +

- 05laser : .

New Comers

Ozurdex

- sustain released dexamethasone intravitreal implant

22G needle

last 6 mths

FDA approved for

BRVO/CRVO associated ME

- non infectious uveitis

New Comers Dexa implant

Ozurdex

Haller J, Kuppermann B, Blumenkranz M.

Randomized Controlled Trial of an Intravitreous Dexamethasone Drug Deliver ySysteminPatientsWi t h Di abet i c Macul ar Edema. Ar ch Opht hal mol 2 0 1 0

persistent DME > 90d, 171 eyes

observation VS Ozurdex 350mcg, 700mcg

6 mths : BCVA improved > 10 letter

23observe %

350 19Ozurdex mcg %

Ozurdex 700 mcg 30%

6 700mths : CRT, FA leakage also better in the mcg groups

New Comers Dexa implant

Ozurdex

Boyer D, Faber D, Gupta S, et al. Dexamethas one Intravitreal Implant for Treatment of Diab etic Macular Edema in Vitrectomized Patients.

Retina 2011

700improved VA and CRT with the mcg impl ant

New Comers fluocinolone implant

I l uvei n

ttttttttt-ttttttt tttttttttttt tttttttttttt implant

25G needle

- 253last . yrs

New Comers fluocinolone implant

iluvein

tttt ttttt

prospective randomized trial

3 yrs data

02 05. mcg/d, . mcg/d, sham

New Comers fluocinolone implant

iluvein

FAME study

3 yrs : >15 letters gain

02 287. mcg/d . %

05 278. mcg/d . %

1 8.9%

all phakic developed cataract

48 81glaucoma Sx . and . %

approved for treating DME in Europe

not in the USA

New ComerEylea

Eylea (Aflibercept)

- FDA approved for AMD

recombinant fusion protein comprising the - key VEGF binding domains of human VEGF

receptors 1 and 2

higher binding affinity versus Lucentis/ Avttttt

New ComerEylea

Eylea (Aflibercept)

Da Vinci trial : phase II

- center involving DME : 5 groups

eylea 0.5mg q 4 wks

eylea 2 mg q 4 wks

eylea 2 mg mthly for 3X, then q 8 wks

eylea 2 mg mthly for 3X, then as needed

laser

New ComerEylea

Da Vinci trial : phase II

1 yr 1 yr

05. mg 05. mg

q 4 wks

2mg 2mg

q 4 wks

2mg for 2mg for 3 8X, thenq wk 3 8X, thenq wk

ss

2mg for 2mg for 3x, the 3x, the

t tttt ttttttttttttt

mean B CVA (lett

ers)110+ .110+ . 131+ .131+ . +9.7+9.7 120+ .120+ . 13+ .13+ .

15gain> letters (

%)409.409. 455.455. 238238 422.422. 114.114.

Mean CR T (mcn)

-165.-165.44

-227.-227.44

-187.-187.88

-180.-180.33

-584.-584.

the time to evolve is NOW!!

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- The role of aflibercept has yet to be established but its Phase II data demonstrates promising effitttt ttt tttttt- - - The extended release steroid devices are intriguing for post vitrectomized eyes or potentially for rtttttttt ttttt tt tt t