Purpose: To assess the efficacy and safety of sub-Tenon injection of triamcinolone acetonide (WP-0508ST) for the patients with diabetic macular edema (DME). Methods: This multicenter, randomized, double-masked, comparative, controlled study was performed in 95 patients with DME. The patients were randomly divided into 20 mg WP-0508ST, 40 mg WP-0508ST, and control groups. Results: A significant improvement in central macular thickness (CMT) was observed (p < 0.001) at 12 weeks after a single sub-Tenon injection of 20 mg WP-0508ST. The 40 mg group also demonstrated improvement in CMT, but the difference was not significant. In addition, the best-corrected visual acuity was improved in both the 20 mg and 40 mg groups at 12 weeks. The major side effects were increased intraocular pressure (9.4% in the 20 mg group and 13.3% in the 40 mg group) and lenticular opacity (6.3% in the 20 mg group and 10.0% in the 40 mg group). However, none of the patients with increased intraocular pressure required surgery. Conclusion: The efficacy and tolerability of WP-0508ST in the treatment of DME were confirmed, and 20 mg was determined to be the optimal dose.

1.
Nozaki
M
.
Anti-VEGF for diabetic retinopathy and diabetic macular edema
.
J Eye
.
2015
;
32
:
349
56
.0910-1810
2.
Jonas
JB
,
Söfker
A
.
Intraocular injection of crystalline cortisone as adjunctive treatment of diabetic macular edema
.
Am J Ophthalmol
.
2001
Sep
;
132
(
3
):
425
7
.
[PubMed]
0002-9394
3.
Ohguro
N
,
Okada
AA
,
Tano
Y
.
Trans-Tenon’s retrobulbar triamcinolone infusion for diffuse diabetic macular edema
.
Graefes Arch Clin Exp Ophthalmol
.
2004
May
;
242
(
5
):
444
5
.
[PubMed]
0721-832X
4.
Sakamoto
T
,
Hida
T
,
Tano
Y
,
Negi
A
,
Takeuchi
S
,
Ishibashi
T
, et al.;
Committee for Triamcinolone Acetonide for Ocular Disease in Japan
.
[Survey of triamcinolone acetonide for ocular diseases in Japan]
.
Nippon Ganka Gakkai Zasshi
.
2007
Dec
;
111
(
12
):
936
45
.
[PubMed]
0029-0203
5.
Thylefors
B
,
Chylack
LT
 Jr
,
Konyama
K
,
Sasaki
K
,
Sperduto
R
,
Taylor
HR
, et al.;
WHO Cataract Grading Group
.
A simplified cataract grading system
.
Ophthalmic Epidemiol
.
2002
Apr
;
9
(
2
):
83
95
.
[PubMed]
0928-6586
6.
Sanjyou
S
,
Takeuchi
M
,
Onaga
M
,
Higuchi
R
.
Comparison of subtenon injection of 20 mg and 40 mg triamcinolone acetonide for macular edema
.
Jpn J Clin Ophtalmol
.
2014
;
68
:
1177
81
.
7.
Torikai
K
,
Mawatari
Y
,
Okamato
Y
,
Ito
Y
,
Koshiyama
Y
,
Fukushima
M
, et al.
Effect of trans-tenon infusion of triamcinolone acetonide for diffuse diabetic macular edema with intact vitreous
.
Jpn J Ophthalmol
.
2006
;
60
:
533
7
.0021-5155
8.
Horii
T
. Clinical findings -History listening.In : Kitaoka T, Yoshimura N, editors. All of diabetic retinopathy clinical treatment. Tokyo; Igaku-shoin ltd;
2013
. pp. 147-54.
9.
Elman
MJ
,
Aiello
LP
,
Beck
RW
,
Bressler
NM
,
Bressler
SB
,
Edwards
AR
, et al.;
Diabetic Retinopathy Clinical Research Network
.
Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema
.
Ophthalmology
.
2010
Jun
;
117
(
6
):
1064
1077.e35
.
[PubMed]
0161-6420
10.
Ogura
Y
,
Sakamoto
T
,
Yoshimura
N
,
Ishibashi
T
.
Phase2/3 Clinical traial of WP-0508 (MaQaid intravitreal injection) for diabetic macular edema
.
J Eye
.
2014
;
31
:
1876
84
.0910-1810
11.
Kusama
M
,
Sakauchi
N
,
Kumaoka
S
.
Studies of plasma levels and urinary excretion after intramuscular injection of triamcinolone acetonide
.
Metabolism
.
1971
Jun
;
20
(
6
):
590
6
.
[PubMed]
0026-0495
12.
Döppenschmitt
SA
,
Scheidel
B
,
Harrison
F
,
Surmann
JP
.
Simultaneous determination of triamcinolone acetonide and hydrocortisone in human plasma by high-performance liquid chromatography
.
J Chromatogr B Biomed Appl
.
1996
Jun
;
682
(
1
):
79
88
.
[PubMed]
1572-6495
13.
Blauert-Cousounis
SP
,
Ziemniak
JA
,
McMahon
SC
,
Grebow
PE
,
Horaham
PA
.
The pharmacokinetics of triamcinolone acetonide after intranasal,oral inhalation and intramuscular administration
.
J Allergy Clin Immunol
.
1989
;
83
:
221
.0091-6749
14.
Nguyen
QD
,
Browner
DS
,
Marcus
DM
,
Boyer
DS
,
Patel
S
,
Feiner
L
, et al.
Rise and ride research group: Ranibizmab for diabetic macular edema: results from phase3 randomized trials: RISE and RIDE
.
Ophthalmology
.
2012
;
119
:
789
801
.
[PubMed]
0161-6420
15.
Korobelnik
JF
,
Do
DV
,
Schmidt-Erfurth
U
,
Boyer
DS
,
Holz
FG
,
Heier
JS
, et al.
Intravitreal aflibercept for diabetic macular edema
.
Ophthalmology
.
2014
Nov
;
121
(
11
):
2247
54
.
[PubMed]
0161-6420
16.
Funatsu
H
,
Noma
H
,
Mimura
T
,
Eguchi
S
,
Hori
S
.
Association of vitreous inflammatory factors with diabetic macular edema
.
Ophthalmology
.
2009
Jan
;
116
(
1
):
73
9
.
[PubMed]
0161-6420
17.
Sonoda
S
,
Sakamoto
T
,
Yamashita
T
,
Shirasawa
M
,
Otsuka
H
,
Sonoda
Y
.
Retinal morphologic changes and concentrations of cytokines in eyes with diabetic macular edema
.
Retina
.
2014
Apr
;
34
(
4
):
741
8
.
[PubMed]
0275-004X
18.
Shimura
M
,
Yasuda
K
,
Yasuda
M
,
Nakazawa
T
.
Visual outcome after intravitreal bevacizumab depends on the optical coherence tomographic patterns of patients with diffuse diabetic macular edema
.
Retina
.
2013
Apr
;
33
(
4
):
740
7
.
[PubMed]
0275-004X
19.
Shimura
M
,
Yasuda
K
,
Nakazawa
T
,
Hirano
Y
,
Sakamoto
T
,
Ogura
Y
, et al.
Visual outcome after intravitreal triamcinolone acetonide depends on optical coherence tomographic patterns in patients with diffuse diabetic macular edema
.
Retina
.
2011
Apr
;
31
(
4
):
748
54
.
[PubMed]
0275-004X
20.
Jeon
S
,
Lee
WK
.
Effect of intravitreal triamcinolone in diabetic macular edema unresponsive to intravitreal bevacizumab
.
Retina
.
2014
Aug
;
34
(
8
):
1606
11
.
[PubMed]
0275-004X
21.
Koga
T
,
Mawatari
Y
,
Inumaru
J
,
Fukushima
M
,
Tanihara
H
.
Trans-Tenon’s retrobulbar triamcinolone acetonide infusion for refractory diabetic macular edema after vitrectomy
.
Graefes Arch Clin Exp Ophthalmol
.
2005
Dec
;
243
(
12
):
1247
52
.
[PubMed]
0721-832X
22.
Sato
H
,
Naito
T
,
Matsushita
S
,
Takebayashi
M
,
Shiota
H
.
Efficacy of sub-Tenon’s capsule injection of triamcinolone acetonide for refractory diabetic macular edema after vitrectomy
.
J Med Invest
.
2008
Aug
;
55
(
3-4
):
279
82
.
[PubMed]
1343-1420
23.
Shimura
M
,
Yasuda
K
,
Shiono
T
.
Posterior sub-Tenon’s capsule injection of triamcinolone acetonide prevents panretinal photocoagulation-induced visual dysfunction in patients with severe diabetic retinopathy and good vision
.
Ophthalmology
.
2006
Mar
;
113
(
3
):
381
7
.
[PubMed]
0161-6420
24.
Kim
HD
,
Kang
KD
,
Choi
KS
,
Rhee
MR
,
Lee
SJ
.
Combined therapy with intravitreal bevacizumab and posterior subtenon triamcinolone acetonide injection in diabetic macular oedema
.
Acta Ophthalmol
.
2014
Nov
;
92
(
7
):
e589
90
.
[PubMed]
1755-375X
25.
Shimura
M
,
Yasuda
K
,
Minezaki
T
,
Noma
H
.
Reduction in the frequency of intravitreal bevacizumab administrations achieved by posterior subtenon injection of triamcinolone acetonide in patients with diffuse diabetic macular edema
.
Jpn J Ophthalmol
.
2016
Sep
;
60
(
5
):
401
7
.
[PubMed]
0021-5155
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