Skip to main content
Erschienen in: International Ophthalmology 1/2020

03.08.2019 | Original Paper

Anti-VEGF versus dexamethasone implant (Ozurdex) for the management of Centre involved Diabetic Macular Edema (CiDME): a randomized study

verfasst von: Ashish Sharma, Keerthi Bellala, Pankaj Dongre, Prahalad Reddy

Erschienen in: International Ophthalmology | Ausgabe 1/2020

Einloggen, um Zugang zu erhalten

Abstract

Purpose

To compare the efficacy and safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection versus dexamethasone implant (Ozurdex) for the treatment of center-involved DME (CiDME).

Method

This prospective randomized comparative study included 40 eyes (38 patients) of CiDME. They were randomized into two groups. Patients in group A received the intravitreal anti-VEGF injection (bevacizumab 1.25 mg or ranibizumab 0.5 mg) and those in group B received dexamethasone implant (0.7 mg) pro-re-nata after 4 weeks and 3 months, respectively. The primary outcome was measured at 3 months from the baseline that included improvement in BCVA, reduction in CFT, and adverse effects during the follow-up period.

Results

Mean best-corrected visual acuity (BCVA) improved from 0.51 ± 0.275 LogMAR units (20/63) to 0.20 ± 0.185 LogMAR units (20/32) in group A and from 0.56 ± 0.213 LogMAR units (20/80) to 0.141 ± 0.177 LogMAR units (20/32) in group B at 3 months. There was no significant difference in mean BCVA between both the groups (p = .27). The mean central foveal thickness (CFT) improved from 443.55 ± 131.536 µ to 277.66 ± 76.184 µ and from 460.95 ± 125.462 µ to 233.25 ± 37.552 µ at 3 months in group B (p = .02).

Conclusion

Both the groups had the similar visual outcome. However, the superior anatomical result was observed in dexamethasone implant group during this short follow-up.
Literatur
1.
Zurück zum Zitat Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BEK (2009) The Wisconsin epidemiologic study of diabetic retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology 116:497–503CrossRef Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BEK (2009) The Wisconsin epidemiologic study of diabetic retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology 116:497–503CrossRef
2.
Zurück zum Zitat Ejaz S, Chekarova I, Ejaz A et al (2008) Importance of pericytes and mechanisms of pericyte loss during diabetes retinopathy. Diabetes Obes Metab 10:53–63PubMed Ejaz S, Chekarova I, Ejaz A et al (2008) Importance of pericytes and mechanisms of pericyte loss during diabetes retinopathy. Diabetes Obes Metab 10:53–63PubMed
3.
Zurück zum Zitat Nguyen QD, Brown DM, Marcus DM et al (2012) RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 119:789–801CrossRef Nguyen QD, Brown DM, Marcus DM et al (2012) RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 119:789–801CrossRef
4.
Zurück zum Zitat Brown DM, Nguyen QD, Marcus DM et al (2013) RISE and RIDE Research Group. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology 120:2013–2022CrossRef Brown DM, Nguyen QD, Marcus DM et al (2013) RISE and RIDE Research Group. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology 120:2013–2022CrossRef
5.
Zurück zum Zitat Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M et al (2010) Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 33:2399–2405CrossRef Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M et al (2010) Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 33:2399–2405CrossRef
6.
Zurück zum Zitat Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV, Boyer D, Heier JS, Abraham P, Thach AB et al (2010) Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 117:2146–2151CrossRef Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV, Boyer D, Heier JS, Abraham P, Thach AB et al (2010) Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology 117:2146–2151CrossRef
7.
Zurück zum Zitat Rajendram R, Fraser-Bell S, Kaines A, Michaelides M, Hamilton RD, Esposti SD, Peto T, Egan C, Bunce C, Leslie RD, Hykin PG (2012) A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch Ophthalmol 130:972–979CrossRef Rajendram R, Fraser-Bell S, Kaines A, Michaelides M, Hamilton RD, Esposti SD, Peto T, Egan C, Bunce C, Leslie RD, Hykin PG (2012) A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch Ophthalmol 130:972–979CrossRef
8.
Zurück zum Zitat Tamura H, Miyamoto K, Kiryu J et al (2005) Intravitreal injection corticosteroid attenuates leukostasis and vascular leakage in experimental diabetic retina. Invest Ophthalmol Vis Sci 46:1440–1444CrossRef Tamura H, Miyamoto K, Kiryu J et al (2005) Intravitreal injection corticosteroid attenuates leukostasis and vascular leakage in experimental diabetic retina. Invest Ophthalmol Vis Sci 46:1440–1444CrossRef
9.
Zurück zum Zitat Haller JA, Bandello F, Belfort R Jr et al (2010) Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 117(6):1134–1146CrossRef Haller JA, Bandello F, Belfort R Jr et al (2010) Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology 117(6):1134–1146CrossRef
10.
Zurück zum Zitat Boyer DS, Yoon YH, Belfort R Jr et al (2014) Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 121(10):1904–1914CrossRef Boyer DS, Yoon YH, Belfort R Jr et al (2014) Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 121(10):1904–1914CrossRef
11.
Zurück zum Zitat Lowder C, Belfort R Jr, Lightman S et al (2011) Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol 129(5):545–553CrossRef Lowder C, Belfort R Jr, Lightman S et al (2011) Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol 129(5):545–553CrossRef
12.
Zurück zum Zitat Gillies M, Lim L, Campain A et al (2004) A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology 121:2473–2481CrossRef Gillies M, Lim L, Campain A et al (2004) A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology 121:2473–2481CrossRef
13.
Zurück zum Zitat Shah SU, Harless A, Bleau L, Maturi RK (2016) Prospective randomized subject-masked study of intravitreal bevacizumab monotherapy versus dexamethasone implant monotherapy in the treatment of persistent diabetic macular edema. Retina 36(10):1986–1996CrossRef Shah SU, Harless A, Bleau L, Maturi RK (2016) Prospective randomized subject-masked study of intravitreal bevacizumab monotherapy versus dexamethasone implant monotherapy in the treatment of persistent diabetic macular edema. Retina 36(10):1986–1996CrossRef
14.
Zurück zum Zitat He Y, Ren XJ, Hu BJ et al (2018) A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmol 18(1):121CrossRef He Y, Ren XJ, Hu BJ et al (2018) A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmol 18(1):121CrossRef
15.
Zurück zum Zitat Mehta H, Fraser-Bell S, Nguyen V et al (2018) Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema. Br J Ophthalmol 102(4):479–482PubMed Mehta H, Fraser-Bell S, Nguyen V et al (2018) Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema. Br J Ophthalmol 102(4):479–482PubMed
16.
Zurück zum Zitat Browning DJ, Glassman AR, Aiello LP et al (2007) The relationship between OCT measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology 114(3):525–536CrossRef Browning DJ, Glassman AR, Aiello LP et al (2007) The relationship between OCT measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology 114(3):525–536CrossRef
17.
Zurück zum Zitat Aroney C, Fraser-Bell S, Lamoureux EL et al (2016) Vision-related quality of life outcomes in the BEVORDEX study: a clinical trial comparing Ozurdex sustained release dexamethasone intravitreal implant and bevacizumab treatment for diabetic macular Edema. Invest Ophthalmol Vis Sci 57(13):5541–5546CrossRef Aroney C, Fraser-Bell S, Lamoureux EL et al (2016) Vision-related quality of life outcomes in the BEVORDEX study: a clinical trial comparing Ozurdex sustained release dexamethasone intravitreal implant and bevacizumab treatment for diabetic macular Edema. Invest Ophthalmol Vis Sci 57(13):5541–5546CrossRef
18.
Zurück zum Zitat Mehta H, Fraser-Bell S, Yeung A et al (2016) Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomized clinical trial. Br J Ophthalmol 100(7):1000–1004CrossRef Mehta H, Fraser-Bell S, Yeung A et al (2016) Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomized clinical trial. Br J Ophthalmol 100(7):1000–1004CrossRef
19.
Zurück zum Zitat Cai S, Bressler NM (2017) Aflibercept, bevacizumab or ranibizumab for diabetic macular oedema: recent clinically relevant findings from DRCR.net Protocol T. Curr Opin Ophthalmol 28(6):636–643CrossRef Cai S, Bressler NM (2017) Aflibercept, bevacizumab or ranibizumab for diabetic macular oedema: recent clinically relevant findings from DRCR.net Protocol T. Curr Opin Ophthalmol 28(6):636–643CrossRef
Metadaten
Titel
Anti-VEGF versus dexamethasone implant (Ozurdex) for the management of Centre involved Diabetic Macular Edema (CiDME): a randomized study
verfasst von
Ashish Sharma
Keerthi Bellala
Pankaj Dongre
Prahalad Reddy
Publikationsdatum
03.08.2019
Verlag
Springer Netherlands
Erschienen in
International Ophthalmology / Ausgabe 1/2020
Print ISSN: 0165-5701
Elektronische ISSN: 1573-2630
DOI
https://doi.org/10.1007/s10792-019-01151-3

Weitere Artikel der Ausgabe 1/2020

International Ophthalmology 1/2020 Zur Ausgabe

Neu im Fachgebiet Augenheilkunde

Ophthalmika in der Schwangerschaft

Die Verwendung von Ophthalmika in der Schwangerschaft und Stillzeit stellt immer eine Off-label-Anwendung dar. Ein Einsatz von Arzneimitteln muss daher besonders sorgfältig auf sein Risiko-Nutzen-Verhältnis bewertet werden. In der vorliegenden …

Operative Therapie und Keimnachweis bei endogener Endophthalmitis

Vitrektomie Originalie

Die endogene Endophthalmitis ist eine hämatogen fortgeleitete, bakterielle oder fungale Infektion, die über choroidale oder retinale Gefäße in den Augapfel eingeschwemmt wird [ 1 – 3 ]. Von dort infiltrieren die Keime in die Netzhaut, den …

Bakterielle endogene Endophthalmitis

Vitrektomie Leitthema

Eine endogene Endophthalmitis stellt einen ophthalmologischen Notfall dar, der umgehender Diagnostik und Therapie bedarf. Es sollte mit geeigneten Methoden, wie beispielsweise dem Freiburger Endophthalmitis-Set, ein Keimnachweis erfolgen. Bei der …

So erreichen Sie eine bestmögliche Wundheilung der Kornea

Die bestmögliche Wundheilung der Kornea, insbesondere ohne die Ausbildung von lichtstreuenden Narben, ist oberstes Gebot, um einer dauerhaften Schädigung der Hornhaut frühzeitig entgegenzuwirken und die Funktion des Auges zu erhalten.   

Update Augenheilkunde

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.