Efficacy of Dexamethasone Intravitreal Implant for the Treatment of Diabetic Macular Edema

Abstract

Purpose

To assess the efficacy of a single dexamethasone intravitreal implant (Dex-I) injection for the treatment of diabetic macular edema (DME).

Methods

This was a retrospective chart review of 39 eyes (34 consecutive patients). Best-corrected visual acuity (BCVA), central macular thickness (CMT), and increase in intraocular pressure (IOP) (>24 mm Hg) were analyzed before treatment and 2 and 4 months after injection.

Results

Preoperative mean CMT was 559 ± 111 μm and decreased to 338 ± 84 and 477 ± 140 μm 2 and 4 months after injection, respectively. Although all eyes showed a significant decrease in CMT 2 months after injection (p<0.0001), a recurrence of the macular edema was observed 4 months after injection in 79% of eyes. Mean BCVA improvement (logMAR) was 0.13 ± 0.18 (p<0.0001) and 0.07 ± 0.21 (p = 0.049) 2 and 4 months after injection, respectively, without significant difference between vitrectomized and nonvitrectomized eyes. Eight eyes (21%) developed reversible increase in IOP 2 months after injection.

Conclusions

Thirty percent of DME eyes had gained more than 2 logMAR lines 2 months after Dex-I injection and safety was good. Visual acuity gain was maintained 4 months after injection despite a recurrence of edema in most cases.

Keywords

Dexamethasone Diabetes Intravitreal implant Macular edema Vitrectomy

Get full access to this article

View all access options for this article.

References

Mitchell

Bandello

Schmidt-Erfurth

; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011; 118: 615–25.

Bressler

S.B.

Qin

Beck

R.W.

; Diabetic Retinopathy Clinical Research Network. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch Ophthalmol 2012; 130: 1153–61.

Nauck

Karakiulakis

Perruchoud

A.P.

Papakonstantinou

Roth

. Corticosteroids inhibit the expression of the vascular endothelial growth factor gene in human vascular smooth muscle cells. Eur J Pharmacol. 1998; 341: 309–15.

Antonetti

D.A.

Wolpert

E.B.

DeMaio

Harhaj

N.S.

Scaduto

R.C.

Jr. . Hydrocortisone decreases retinal endothelial cell water and solute flux coincident with increased content and decreased phosphorylation of occludin. J Neurochem. 2002; 80: 667–77.

Gillies

M.C.

Sutter

F.K.P.

Simpson

J.M.

Larsson

Ali

Zhu

. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006; 113: 1533–8.

Gillies

M.C.

McAllister

I.L.

Zhu

. Intravitreal triamcinolone prior to laser treatment of diabetic macular edema: 24-month results of a randomized controlled trial. Ophthalmology. 2011; 118: 866–72.

Massin

Audren

Haouchine

. Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology. 2004; 111: 218–24; discussion 224–5.

Beck

R.W.

Edwards

A.R.

Aiello

L.P.

; Diabetic Retinopathy Clinical Research Network (DRCR.net). Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009; 127: 245–51.

Elman

M.J.

Bressler

N.M.

Qin

; Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011; 118: 609–14.

10.

Elman

M.J.

Aiello

L.P.

Beck

R.W.

. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010; 117: 1064–77.

11.

Campochiaro

P.A.

Brown

D.M.

Pearson

; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012; 119: 2125–32.

12.

Haller

J.A.

Bandello

Belfort

Jr. ; Ozurdex GENEVA Study Group. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results. Ophthalmology. 2011; 118: 2453–60.

13.

Lowder

Belfort

Jr. Lightman

; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011; 129: 545–53.

14.

Haller

J.A.

Kuppermann

B.D.

Blumenkranz

M.S.

; Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010; 128: 289–96.

15.

Callanan

D.G.

Gupta

Boyer

D.S.

; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013; 120: 1843–51.

16.

Boyer

D.S.

Faber

Gupta

; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011; 31: 915–23.

17.

Wolf-Schnurrbusch

U.E.K.

Ceklic

Brinkmann

C.K.

. Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci. 2009; 50: 3432–7.

18.

Chan

Duker

J.S.

. A standardized method for reporting changes in macular thickening using optical coherence tomography. Arch Ophthalmol 2005; 123: 939–43.

19.

Zucchiatti

Lattanzio

Querques

. Intravitreal dexamethasone implant in patients with persistent diabetic macular edema. Ophthalmologica. 2012; 228: 117–22.

20.

Heier

J.S.

Campochiaro

P.A.

Yau

. Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial. Ophthalmology. 2012; 119: 802–9.

21.

Diabetic Retinopathy Clinical Research Network Writing Committee, Haller

J.A.

Qin

. Vitrectomy outcomes in eyes with diabetic macular edema and vitreomacular traction. Ophthalmology. 2010; 117: 1087–93.

22.

Yanyali

Aytug

Horozoglu

Nohutcu

A.F.

. Bevacizumab (Avastin) for diabetic macular edema in previously vitrectomized eyes. Am J Ophthalmol. 2007; 144: 124–6.

23.

Chang-Lin

J-E

Burke

J.A.

Peng

. Pharmacokinetics of a sustained-release dexamethasone intravitreal implant in vitrectomized and nonvitrectomized eyes. Invest Ophthalmol Vis Sci. 2011; 52: 4605–9.

24.

Chin

H-S

Park

T-S

Moon

Y-S

J-H

. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina. 2005; 25: 556–60.

25.

Kreines

Weinberg

I.C.

. The selection of adrenocorticosteroid preparations. Ohio State Med J. 1975; 71: 698, 703–6.

26.

Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008; 115: 1447–9.

27.

Audren

Lecleire-Collet

Erginay

. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006; 142: 794–9.

28.

Boyer

D.S.

Yoon

Y.H.

Belfort

Jr. ; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014; 121: 1904–14.