Login Register Cart 0
Generic placeholder image

Current Drug Delivery

Editor-in-Chief

ISSN (Print): 1567-2018
ISSN (Online): 1875-5704

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Clinical Trial

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab Injection for Treatment of Non-Proliferative Diabetic Macular Edema: A Prospective, Randomized and Blinded Trial

Author(s): Sanjay Kumar Mishra, Shruti Sinha, Ravi Chauhan* and Ashok Kumar

Volume 18, Issue 6, 2021

Published on: 01 December, 2020

Page: [825 - 832] Pages: 8

DOI: 10.2174/1567201817666201202093637

Price: $65

Abstract

Introduction: In the working age population, Diabetic Macular Edema (DME) is the most common cause of visual loss.

Purpose: The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre upto 4 months.

Methods: This is a comparative, prospective, randomized study that was done on 140 patients with macular edema confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland); the groups were followed up at day-1 and weeks 4, 8, 12, 16. Patients were divided into Group A, in which patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B patients were given a single dose of IVD implant 0.7 mg (n=70).

Results: The mean number of injections given was 1 Ozurdex® per patient vs. 3 Lucentis® per patient. The maximum reduction in central macular thickness (CMT) with IVD was 167.8 μm and 138.8μm in the 2nd and 3rd months, respectively, with IVR. The mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD and IVR groups, respectively, with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15 letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4%, and 20.4, 18.8, 20.3 20.3% in IVR groups, respectively. The maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17%). IOP rise >10 mmHg was observed in 14/63 patients (22.22%); the majority of patients indicated a high rise at 2nd month with all returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either of the treated groups.

Conclusion: Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence of CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow- up would be performed to justify the obtained results in the present study.

Keywords: Intravitreal, dexamethasone, ranibizumab, implant, injection, treatment, clinical trial, diabetic macular edema.

« Previous
Graphical Abstract

[1]
Zhang, X.; Saaddine, J.B.; Chou, C.F.; Cotch, M.F.; Cheng, Y.J.; Geiss, L.S.; Gregg, E.W.; Albright, A.L.; Klein, B.E.; Klein, R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA, 2010, 304(6), 649-656.
[http://dx.doi.org/10.1001/jama.2010.1111] [PMID: 20699456]
[2]
Sharma, S.; Jha, J.; Varshney, A.; Chauhan, L. Awareness of various aspects of diabetes among people visiting tertiary eye care institute in north India. Clin. Epidemiol. Glob. Health, 2020, 8(1), 96-100.
[http://dx.doi.org/10.1016/j.cegh.2019.05.002]
[3]
Yau, J.W.; Rogers, S.L.; Kawasaki, R.; Lamoureux, E.L.; Kowalski, J.W.; Bek, T.; Chen, S.J.; Dekker, J.M.; Fletcher, A.; Grauslund, J.; Haffner, S.; Hamman, R.F.; Ikram, M.K.; Kayama, T.; Klein, B.E.; Klein, R.; Krishnaiah, S.; Mayurasakorn, K.; O’Hare, J.P.; Orchard, T.J.; Porta, M.; Rema, M.; Roy, M.S.; Sharma, T.; Shaw, J.; Taylor, H.; Tielsch, J.M.; Varma, R.; Wang, J.J.; Wang, N.; West, S.; Xu, L.; Yasuda, M.; Zhang, X.; Mitchell, P.; Wong, T.Y. Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care, 2012, 35(3), 556-564.
[http://dx.doi.org/10.2337/dc11-1909] [PMID: 22301125]
[4]
Das, T.; Aurora, A.; Chhablani, J.; Giridhar, A.; Kumar, A.; Raman, R.; Nagpal, M.; Narayanan, R.; Natarajan, S.; Ramasamay, K.; Tyagi, M.; Verma, L. Evidence-based review of diabetic macular edema management: Consensus statement on Indian treatment guidelines. Indian J. Ophthalmol., 2016, 64(1), 14-25.
[http://dx.doi.org/10.4103/0301-4738.178142] [PMID: 26953019]
[5]
Cui, Q.N.; Stewart, J.M. Intravitreal dexamethasone implant (Ozurdex) as primary treatment for diabetic macular edema. Invest. Ophthalmol. Vis. Sci., 2014, 55(13), 1780.
[6]
Johnson, M.W. Etiology and treatment of macular edema. Am. J. Ophthalmol., 2009, 147(1), 11-21.e1.
[http://dx.doi.org/10.1016/j.ajo.2008.07.024] [PMID: 18789796]
[7]
Callanan, D.G.; Loewenstein, A.; Patel, S.S.; Massin, P.; Corcóstegui, B.; Li, X.Y.; Jiao, J.; Hashad, Y.; Whitcup, S.M. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch. Clin. Exp. Ophthalmol., 2017, 255(3), 463-473.
[http://dx.doi.org/10.1007/s00417-016-3472-1] [PMID: 27632215]
[8]
Pacella, F.; Ferraresi, A.F.; Turchetti, P.; Lenzi, T.; Giustolisi, R.; Bottone, A.; Fameli, V.; Romano, M.R.; Pacella, E. Intravitreal injection of Ozurdex® implant in patients with persistent diabetic macular edema, with six-month follow-up. Ophthalmol. eye dis., 2016, 8(11), 6.
[9]
Shah, A.R.; Del Priore, L.V. Duration of action of intravitreal ranibizumab and bevacizumab in exudative AMD eyes based on macular volume measurements. Br. J. Ophthalmol., 2009, 93(8), 1027-1032.
[http://dx.doi.org/10.1136/bjo.2008.149674] [PMID: 19429594]
[10]
Castro-Navarro, V.; Cervera-Taulet, E.; Navarro-Palop, C.; Monferrer-Adsuara, C.; Hernández-Bel, L.; Montero-Hernández, J. Intravitreal dexamethasone implant Ozurdex® in naïve and refractory patients with different subtypes of diabetic macular edema. BMC Ophthalmol., 2019, 19(1), 15.
[http://dx.doi.org/10.1186/s12886-018-1022-9] [PMID: 30634940]
[11]
Massin, P.; Bandello, F.; Garweg, J.G.; Hansen, L.L.; Harding, S.P.; Larsen, M.; Mitchell, P.; Sharp, D.; Wolf-Schnurrbusch, U.E.; Gekkieva, M.; Weichselberger, A.; Wolf, S. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): A 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care, 2010, 33(11), 2399-2405.
[http://dx.doi.org/10.2337/dc10-0493] [PMID: 20980427]
[12]
Nguyen, Q.D.; Shah, S.M.; Khwaja, A.A.; Channa, R.; Hatef, E.; Do, D.V.; Boyer, D.; Heier, J.S.; Abraham, P.; Thach, A.B.; Lit, E.S.; Foster, B.S.; Kruger, E.; Dugel, P.; Chang, T.; Das, A.; Ciulla, T.A.; Pollack, J.S.; Lim, J.I.; Eliott, D.; Campochiaro, P.A. READ-2 Study Group. Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study. Ophthalmology, 2010, 117(11), 2146-2151.
[http://dx.doi.org/10.1016/j.ophtha.2010.08.016] [PMID: 20855114]
[13]
Mitchell, P.; Bandello, F.; Schmidt-Erfurth, U.; Lang, G.E.; Massin, P.; Schlingemann, R.O.; Sutter, F.; Simader, C.; Burian, G.; Gerstner, O.; Weichselberger, A. RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology, 2011, 118(4), 615-625.
[http://dx.doi.org/10.1016/j.ophtha.2011.01.031] [PMID: 21459215]
[14]
Brown, D.M.; Nguyen, Q.D.; Marcus, D.M.; Boyer, D.S.; Patel, S.; Feiner, L.; Schlottmann, P.G.; Rundle, A.C.; Zhang, J.; Rubio, R.G.; Adamis, A.P.; Ehrlich, J.S.; Hopkins, J.J. RIDE and RISE 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, 2013, 120(10), 2013-2022.
[http://dx.doi.org/10.1016/j.ophtha.2013.02.034] [PMID: 23706949]
[15]
Boyer, D.S.; Yoon, Y.H.; Belfort, R., Jr; Bandello, F.; Maturi, R.K.; Augustin, A.J.; Li, X.Y.; Cui, H.; Hashad, Y.; Whitcup, S.M. Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology, 2014, 121(10), 1904-1914.
[http://dx.doi.org/10.1016/j.ophtha.2014.04.024] [PMID: 24907062]
[16]
Gillies, M.C.; Lim, L.L.; Campain, A.; Quin, G.J.; Salem, W.; Li, J.; Goodwin, S.; Aroney, C.; McAllister, I.L.; Fraser-Bell, S. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: The BEVORDEX study. Ophthalmology, 2014, 121(12), 2473-2481.
[http://dx.doi.org/10.1016/j.ophtha.2014.07.002] [PMID: 25155371]
[17]
Mehta, H.; Gillies, M.; Fraser-Bell, S. Perspective on the role of Ozurdex (dexamethasone intravitreal implant) in the management of diabetic macular oedema. Ther. Adv. Chronic Dis., 2015, 6(5), 234-245.
[http://dx.doi.org/10.1177/2040622315590319] [PMID: 26336592]
[18]
Hattenbach, L.O.; Feltgen, N.; Bertelmann, T.; Schmitz-Valckenberg, S.; Berk, H.; Eter, N.; Lang, G.E.; Rehak, M.; Taylor, S.R.; Wolf, A.; Weiss, C.; Paulus, E.M.; Pielen, A.; Hoerauf, H. COMRADE-B Study Group. Head-to-head comparison of ranibizumab PRN versus single-dose dexamethasone for branch retinal vein occlusion (COMRADE-B). Acta Ophthalmol., 2018, 96(1), e10-e18.
[http://dx.doi.org/10.1111/aos.13381] [PMID: 28251811]
[19]
Mello Filho, P.; Andrade, G.; Maia, A.; Maia, M.; Biccas Neto, L.; Muralha Neto, A.; Moura Brasil, O.; Minelli, E.; Dalloul, C.; Iglicki, M. Effectiveness and safety of intravitreal dexamethasone implant (Ozurdex) in patients with diabetic macular edema: A real-world experience. Ophthalmologica, 2019, 241(1), 9-16.
[http://dx.doi.org/10.1159/000492132] [PMID: 30408801]
[20]
Chatziralli, I.; Theodossiadis, G.; Kabanarou, S.A.; Parikakis, E.; Xirou, T.; Mitropoulos, P.; Theodossiadis, P. Ranibizumab versus dexamethasone implant for central retinal vein occlusion: the RANIDEX study. Graefes Arch. Clin. Exp. Ophthalmol., 2017, 255(10), 1899-1905.
[http://dx.doi.org/10.1007/s00417-017-3719-5] [PMID: 28620704]
[21]
Bandello, F.; Augustin, A.; Tufail, A.; Leaback, R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur. J. Ophthalmol., 2018, 28(6), 697-705.
[http://dx.doi.org/10.1177/1120672117750058] [PMID: 29631435]
[22]
Wei, Q.; Chen, R.; Lou, Q.; Yu, J. Intravitreal corticosteroid implant vs intravitreal ranibizumab for the treatment of macular edema: A meta-analysis of randomized controlled trials. Drug Des. Devel. Ther., 2019, 13, 301-307.
[http://dx.doi.org/10.2147/DDDT.S184520] [PMID: 30666092]
[23]
Abedini, F.; Ebrahimi, M.; Roozbehani, A.H.; Domb, A.J.; Hosseinkhani, H. Overview on natural hydrophilic polysaccharide polymers in drug delivery. Polym. Adv. Technol., 2018, 29(10), 2564-2573.
[http://dx.doi.org/10.1002/pat.4375]
[24]
Hosseinkhani, H.; Domb, A.J. Biodegradable polymers in gene-silencing technology. Polym. Adv. Technol., 2019, 30(10), 2647-2655.
[http://dx.doi.org/10.1002/pat.4713]
[25]
Mottaghitalab, F.; Farokhi, M.; Shokrgozar, M.A.; Atyabi, F.; Hosseinkhani, H. Silk fibroin nanoparticle as a novel drug delivery system. J. Control. Release, 2015, 206, 161-176.
[http://dx.doi.org/10.1016/j.jconrel.2015.03.020] [PMID: 25797561]

Rights & Permissions Print Cite
Article Metrics
24
© 2024 Bentham Science Publishers | Privacy Policy