References

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Clinical Review Report: Dexamethasone (Ozurdex): (Allergan Inc.): Indication: For the treatment of adult patients with diabetic macular edema who are pseudophakic [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Nov.

Cover of Clinical Review Report: Dexamethasone (Ozurdex)

Clinical Review Report: Dexamethasone (Ozurdex): (Allergan Inc.): Indication: For the treatment of adult patients with diabetic macular edema who are pseudophakic [Internet].

Show details

Contents

< PrevNext >

References

1.: Mohamed Q, Gillies MC, Wong TY. Management of diabetic retinopathy: a systematic review. JAMA. 2007;298(8):902–916. [PubMed: 17712074]
2.: Petrella RJ, Blouin J, Davies B, Barbeau M. Prevalence, demographics, and treatment characteristics of visual impairment due to diabetic macular edema in a representative Canadian cohort. J Ophthalmol. 2012;2012:159167. [PMC free article: PMC3529901] [PubMed: 23304447]
3.: Diabetes in Canada. Toronto: Canadian Diabetes Association; 2016.
4.: Tennant MT. Ocular treatment of diabetic macular edema in Canada: where are we going? Can J Ophthalmol. 2011;46(3):221–224. [PubMed: 21784205]
5.: Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615–625. [PubMed: 21459215]
6.: Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193–1203. [PMC free article: PMC4422053] [PubMed: 25692915]
7.: Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247–2254. [PubMed: 25012934]
8.: Mitchell P. Three-year safety and efficacy of ranibizumab in patients with visual impairment due to diabetic macular edema: The RESTORE Extension Study. Abstract presented at: American Academy of Ophthalmology Annual Meeting; 2012 Nov 12; Chicago IL. 2017.
9.: Gonzalez VH, Campbell J, Holekamp NM, et al. Early and long-term responses to anti-vascular endothelial growth factor therapy in diabetic macular edema: analysis of protocol I data. Am J Ophthalmol. 2016;172:72–79. [PubMed: 27644589]
10.: Hooper P, Boucher MC, Colleaux K, et al. Contemporary management of diabetic retinopathy in Canada: from guidelines to algorithm guidance. Ophthalmologica. 2014;231(1):2–15. [PubMed: 24246998]
11.: Hooper P, Boucher MC, Cruess A, et al. Canadian Ophthalmological Society evidence-based clinical practice guidelines for the management of diabetic retinopathy. Can J Ophthalmol. 2012;47:(2 Suppl):S1–30, s31–54. [PubMed: 22632804]
12.: Ozurdex (dexamethasone): intravitreal implant 0.7 mg [product monograph]. Markham (ON): Allergan Inc.; 2015 Apr 14.
13.: Golan S, Loewenstein A. Steroids and the management of macular edema. Ophthalmologica. 2010;224: Suppl 1:31–40. [PubMed: 20714179]
14.: London NJ, Chiang A, Haller JA. The dexamethasone drug delivery system: indications and evidence. Adv Ther. 2011;28(5):351–366. [PubMed: 21494891]
15.: Stewart MW. The expanding role of vascular endothelial growth factor inhibitors in ophthalmology. Mayo Clin Proc. 2012;87(1):77–88. [PMC free article: PMC3498409] [PubMed: 22212972]
16.: Enyedi LB, Pearson PA, Ashton P, Jaffe GJ. An intravitreal device providing sustained release of cyclosporine and dexamethasone. Curr Eye Res. 1996;15(5):549–557. [PubMed: 8670756]
17.: Leopold IH. Nonsteroidal and steroidal anti-inflammatory agents. In: Sears M, Tarkkanen A, eds. Surgical Pharmacology of the Eye. New York: Raven Press; 1985.
18.: Tennant JL. Cystoid maculopathy: 125 prostaglandins in ophthalmology. In: Emery JM, ed. Current concepts in cataract surgery: selected proceedings of the fifth biennial cataract surgical congress. St. Louis (MO): C.V. Mosby; 1978:360–362.
19.: Sarao V, Veritti D, Boscia F, Lanzetta P. Intravitreal steroids for the treatment of retinal diseases. ScientificWorldJournal. 2014;2014:989501. [PMC free article: PMC3910383] [PubMed: 24526927]
20.: Lloyd AJ, Loftus J, Turner M, Lai G, Pleil A. Psychometric validation of the Visual Function Questionnaire-25 in patients with diabetic macular edema. Health Qual Life Outcomes. 2013;11:10. [PMC free article: PMC3599421] [PubMed: 23347793]
21.: Khan Z, Kuriakose RK, Khan M, Chin EK, Almeida DR. Efficacy of the intravitreal sustained-release dexamethasone implant for diabetic macular edema refractory to anti-vascular endothelial growth factor therapy: meta-analysis and clinical implications. Ophthalmic Surg Lasers Imaging Retina. 2017;48(2):160–166. [PubMed: 28195619]
22.: Pacella F, Romano MR, Turchetti P, et al. An eighteen-month follow-up study on the effects of intravitreal dexamethasone implant in diabetic macular edema refractory to anti-VEGF therapy. Int J Ophthalmol. 2016;9(10):1427–1432. [PMC free article: PMC5075657] [PubMed: 27803859]
23.: Clinical Study Report: 206207-010. A 3-year, phase 3, multicenter, masked, randomized, sham-controlled trial to assess the safety and efficacy of 700 mg dexamethasone posterior segment drug delivery system (DEX PS DDS) applicator system in the treatment of patients with diabetic macular edema [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan; 2013.
24.: Clinical Study Report: 206207-011. A 3-year, phase 3, multicenter, masked, randomized, sham-controlled trial to assess the safety and efficacy of 700 mg dexamethasone posterior segment drug delivery system (DEX PS DDS) applicator system in the treatment of patients with diabetic macular edema [CONFIDENTIAL internal manufacturer’s report]. Irvine (CA): Allergan Inc.; 2013.
25.: Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008;88(11):1322–1335. [PMC free article: PMC2579903] [PubMed: 18801863]
26.: Kaiser PK. Prospective evaluation of visual acuity assessment: a comparison of Snellen versus ETDRS charts in clinical practice (An AOS Thesis). Trans Am Ophthalmol Soc. 2009;107:311–324. [PMC free article: PMC2814576] [PubMed: 20126505]
27.: Williams R, Airey M, Baxter H, Forrester J, Kennedy-Martin T, Girach A. Epidemiology of diabetic retinopathy and macular oedema: a systematic review. Eye (Lond). 2004;18(10):963–983. [PubMed: 15232600]
28.: Ciulla TA, Amador AG, Zinman B. Diabetic retinopathy and diabetic macular edema: pathophysiology, screening, and novel therapies. Diabetes Care. 2003;26(9):2653–2664. [PubMed: 12941734]
29.: Kempen JH, O’Colmain BJ, Leske MC, et al. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004;122(4):552–563. [PubMed: 15078674]
30.: Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984;91(12):1464–1474. [PubMed: 6521986]
31.: Kaur H, Maberley D, Chang A, Hay D. The current status of diabetes care, diabetic retinopathy screening and eye-care in British Columbia’s First Nations communities. Int J Circumpolar Health. 2004;63(3):277–285. [PubMed: 15526931]
32.: Maberley D, Walker H, Koushik A, Cruess A. Screening for diabetic retinopathy in James Bay, Ontario: a cost-effectiveness analysis. CMAJ. 2003;168(2):160–164. [PMC free article: PMC140424] [PubMed: 12538543]
33.: Vu HT, Keeffe JE, McCarty CA, Taylor HR. Impact of unilateral and bilateral vision loss on quality of life. Br J Ophthalmol. 2005;89(3):360–363. [PMC free article: PMC1772562] [PubMed: 15722319]
34.: Cusick M, Meleth AD, Agron E, et al. Associations of mortality and diabetes complications in patients with type 1 and type 2 diabetes: early treatment diabetic retinopathy study report no. 27. Diabetes Care. 2005;28(3):617–625. [PubMed: 15735198]
35.: Happich M, Reitberger U, Breitscheidel L, Ulbig M, Watkins J. The economic burden of diabetic retinopathy in Germany in 2002. Graefes Arch Clin Exp Ophthalmol. 2008;246(1):151–159. [PubMed: 17406883]
36.: Davidov E, Breitscheidel L, Clouth J, Reips M, Happich M. Diabetic retinopathy and health-related quality of life. Graefes Arch Clin Exp Ophthalmol. 2009;247(2):267–272. [PubMed: 18925408]
37.: Gonder JR, Walker VM, Barbeau M, et al. Costs and Quality of Life in Diabetic Macular Edema: Canadian Burden of Diabetic Macular Edema Observational Study (C-REALITY). J Ophthalmol. 2014;2014:939315. [PMC free article: PMC3984851] [PubMed: 24795818]
38.: Sander B, Thornit DN, Colmorn L, et al. Progression of diabetic macular edema: correlation with blood retinal barrier permeability, retinal thickness, and retinal vessel diameter. Invest Ophthalmol Vis Sci. 2007;48(9):3983–3987. [PubMed: 17724176]
39.: Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009;54(1):1–32. [PubMed: 19171208]
40.: Kowalczuk L, Touchard E, Omri S, et al. Placental growth factor contributes to micro-vascular abnormalization and blood-retinal barrier breakdown in diabetic retinopathy. PLoS ONE. 2011;6(3):e17462. [PMC free article: PMC3049767] [PubMed: 21408222]
41.: Zhang X, Zeng H, Bao S, Wang N, Gillies MC. Diabetic macular edema: new concepts in patho-physiology and treatment. Cell Biosci. 2014;4:27. [PMC free article: PMC4046142] [PubMed: 24955234]
42.: Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985;103(12):1796–1806. [PubMed: 2866759]
43.: Goatman KA. A reference standard for the measurement of macular oedema. Br J Ophthalmol. 2006;90(9):1197–1202. [PMC free article: PMC1857383] [PubMed: 16929064]
44.: Jain A, Varshney N, Smith C. The evolving treatment options for diabetic macular edema. Int J Inflam. 2013:689276. [PMC free article: PMC3782842] [PubMed: 24106640]
45.: Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324(7329):71–86. [PMC free article: PMC64503] [PubMed: 11786451]
46.: Lucentis (ranibizumab injection): single use vials: 10 mg/mL solution for injection [product monograph]. Dorval (QC): Novartis Pharmaceuticals Canada Inc.; 2017 Nov 3: https://pdf.hres.ca/dpd_pm/00042080.PDF. Accessed 2018 Sep 28.
47.: Eylea^®: aflibercept single use vials for the treatment of a single eye 40 mg/mL solution for intravitreal injection ophthalmological / antineovascularization agent [product monograph]. Mississauga (ON): Bayer Inc.; 2018 Jun 1: https://pdf.hres.ca/dpd_pm/00046211.PDF. Accessed 2018 Sep 28.
48.: Anti-vascular endothelial growth factor drugs for the treatment of retinal conditions - recommendations report. (CADTH Therapeutic review vol. 3, no. 2c). Ottawa: CADTH; 2016: https://www.cadth.ca/sites/default/files/pdf/TR0009_Anti-VEGFs_Recs_Report.pdf. Accessed 2017 Dec 6.
49.: Boyer DS, Yoon YH, Belfort R, Jr., et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121(10):1904–1914. [PubMed: 24907062]
50.: CDR submission: Ozurdex (dexamethasone) for diabetic macular edema, intravitreal implant, 07 mg. Company: Allergan Inc. [CONFIDENTIAL manufacturer’s submission]. Markham (ON): Allergan Inc.; 2017 Sep 23.
51.: Health Canada’s reviewer’s report: Ozurdex (dexamethasone intravitreal implant) [CONFIDENTIAL internal report]. Ottawa (ON): Therapeutics Products Directorate, Health Canada; 2015. Accessed 2015.
52.: Center for Drug Evaluation and Research. Statistical review(s). Ozurdex (dexamethasone implant). Company: Allergan, Inc. Application no.: 022315. Approval date: 6/17/2009 (FDA drug approval package). Rockville (MD): U.S. Food and Drug Administration (FDA); 2009: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022315_ozurdex_toc.cfm. Accessed 2017 Nov 20.
53.: Type 2 diabetes: lixisenatide. Evidence summary. (NICE evidence summary ESNM26). London (GB): National Instiute for Health and Care Excellence; 2013: https://www.nice.org.uk/guidance/esnm26/resources/type-2-diabetes-lixisenatide-pdf-1502680866716869. Accessed 2017 Dec 6.
54.: Rosser DA, Cousens SN, Murdoch IE, Fitzke FW, Laidlaw DA. How sensitive to clinical change are ETDRS logMAR visual acuity measurements? Invest Ophthalmol Vis Sci. 2003;44(8):3278–3281. [PubMed: 12882770]
55.: Beck RW, Maguire MG, Bressler NM, Glassman AR, Lindblad AS, Ferris FL. Visual acuity as an outcome measure in clinical trials of retinal diseases. Ophthalmology. 2007;114(10):1804–1809. [PubMed: 17908590]
56.: Diabetic Retinopathy Clinical Research Network, Browning DJ, Glassman AR, et al. The relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology. 2007;114(3):525–536. [PMC free article: PMC2585542] [PubMed: 17123615]
57.: Davis MD, Bressler SB, Aiello LP, et al. Comparison of time-domain OCT and fundus photographic assessments of retinal thickening in eyes with diabetic macular edema. Invest Ophthalmol Vis Sci. 2008;49(5):1745–1752. [PMC free article: PMC2408888] [PubMed: 18316700]
58.: Nunes S, Pereira I, Santos A, Bernardes R, Cunha-Vaz J. Central retinal thickness measured with HD-OCT shows a weak correlation with visual acuity in eyes with CSME. Br J Ophthalmol. 2010;94(9):1201–1204. [PubMed: 20530184]
59.: Marella M, Pesudovs K, Keeffe JE, O’Connor PM, Rees G, Lamoureux EL. The psychometric validity of the NEI VFQ-25 for use in a low-vision population. Invest Ophthalmol Vis Sci. 2010;51(6):2878–2884. [PubMed: 20089878]
60.: Pesudovs K, Gothwal VK, Wright T, Lamoureux EL. Remediating serious flaws in the National Eye Institute Visual Function Questionnaire. J Cataract Refract Surg. 2010;36(5):718–732. [PubMed: 20457362]
61.: Kapoor KG, Colchao JB. Safety of consecutive same-day bilateral intravitreal dexamethasone implant (Ozurdex). Retin Cases Brief Rep. 2017. [PubMed: 29155696]
62.: Haller JA, Kuppermann BD, Blumenkranz MS, et al. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010;128(3):289–296. [PubMed: 20212197]
63.: Heng LZ, Sivaprasad S, Crosby-Nwaobi R, et al. A prospective randomised controlled clinical trial comparing a combination of repeated intravitreal Ozurdex and macular laser therapy versus macular laser only in centre-involving diabetic macular oedema (OZLASE study). Br J Ophthalmol. 2016;100(6):802–807. [PubMed: 26472406]
64.: Maturi RK, Bleau L, Saunders J, Mubasher M, Stewart MW. A 12-month, single-masked, randomized controlled study of eyes with persistent diabetic macular edema after multiple anti-VEGF injections to assess the efficacy of the dexamethasone-delayed delivery system as an adjunct to bevacizumab compared with continued bevacizumab monotherapy. Retina. 2015;35(8):1604–1614. [PubMed: 25829346]
65.: Shah SU, Harless A, Bleau L, Maturi RK. Prospective randomized subject-masked study of intravitreal bevacizumab monotherapy versus dexamethasone implant monotherapy in the treatment of persistent diabetic macular edema. Retina. 2016;36(10):1986–1996. [PubMed: 27124881]
66.: Kniestedt C, Stamper RL. Visual acuity and its measurement. Ophthalmol Clin North Am. 2003;16(2):155–170. [PubMed: 12809155]
67.: Center for Drug Evaluation and Research. Medical review(s). Lucentis (ranibizumab). Company:Genentech. Application no.: 125156. Approval date: 06/30/2006 (FDA drug approval package). Rockville (MD): U. S. Food and Drug Administration (FDA); 2006: https://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/125156Orig1s053.pdf. Accessed 2017 Nov 20.
68.: Mangione CM, Berry S, Spritzer K, et al. Identifying the content area for the 51-item National Eye Institute Visual Function Questionnaire: results from focus groups with visually impaired persons. Arch Ophthalmol. 1998;116(2):227–233. [PubMed: 9488276]
69.: Mangione CM, Lee PP, Gutierrez PR, et al. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001;119(7):1050–1058. [PubMed: 11448327]
70.: Dougherty BE, Bullimore MA. Comparison of scoring approaches for the NEI VFQ-25 in low vision. Optom Vis Sci. 2010;87(8):543–548. [PMC free article: PMC2924616] [PubMed: 20526224]
71.: Tewari HK, Kori V, Sony P, Venkatesh P, Garg S. Snellen chart may be preferable over early treatment diabetic retinopathy study charts for rapid visual acuity assessment. Indian J Ophthalmol. 2006;54(3):214. [PubMed: 16921230]
72.: Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419–1431. [PubMed: 17021318]
73.: Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1432–1444. [PubMed: 17021319]
74.: Dong LM, Childs AL, Mangione CM, et al. Health- and vision-related quality of life among patients with choroidal neovascularization secondary to age-related macular degeneration at enrollment in randomized trials of submacular surgery: SST report no. 4. Am J Ophthalmol. 2004;138(1):91–108. [PubMed: 15234287]
75.: Beck RW, Moke PS, Turpin AH, et al. A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol. 2003;135(2):194–205. [PubMed: 12566024]
76.: CATT: comparison of age-related macular degeneration treatment trials. ETDRS chart worksheet. Philadelphia (PA): University of Pennsylvania; 2014.
77.: Recommended standard procedures for the clinical measurement and specification of visual acuity. Report of working group 39. Committee on vision. Assembly of Behavioral and Social Sciences, National Research Council, National Academy of Sciences, Washington, D.C. Adv Ophthalmol. 1980;41:103–148. [PubMed: 7001873]
78.: Ricci F, Cedrone C, Cerulli L. Standardized measurement of visual acuity. Ophthalmic Epidemiol. 1998;5(1):41–53. [PubMed: 9575537]
79.: Joussen AM, Lehmacher W, Hilgers RD, Kirchhof B. Is significant relevant? Validity and patient benefit of randomized controlled clinical trials on age-related macular degeneration. Surv Ophthalmol. 2007;52(3):266–278. [PubMed: 17472802]
80.: Slakter JS, Stur M. Quality of life in patients with age-related macular degeneration: impact of the condition and benefits of treatment. Surv Ophthalmol. 2005;50(3):263–273. [PubMed: 15850815]
81.: Hazel CA, Petre KL, Armstrong RA, Benson MT, Frost NA. Visual function and subjective quality of life compared in subjects with acquired macular disease. Invest Ophthalmol Vis Sci. 2000;41(6):1309–1315. [PubMed: 10798645]
82.: Matt G, Sacu S, Buehl W, et al. Comparison of retinal thickness values and segmentation performance of different OCT devices in acute branch retinal vein occlusion. Eye. 2011;25(4):511–518. [PMC free article: PMC3171252] [PubMed: 21293498]
83.: Diabetic Retinopathy Clinical Research Network Writing Committee, Bressler SB, Edwards AR, et al. Reproducibility of spectral-domain optical coherence tomography retinal thickness measurements and conversion to equivalent time-domain metrics in diabetic macular edema. JAMA Ophthalmol. 2014;132(9):1113–1122. [PMC free article: PMC4366946] [PubMed: 25058482]
84.: Hernandez-Martinez C, Palazon-Bru A, Azrak C, et al. Detection of diabetic macular oedema: validation of optical coherence tomography using both foveal thickness and intraretinal fluid. Peerj. 2015;3:e1394. [PMC free article: PMC4647548] [PubMed: 26587352]
85.: Lammer J, Scholda C, Prunte C, Benesch T, Schmidt-Erfurth U, Bolz M. Retinal thickness and volume measurements in diabetic macular edema: a comparison of four optical coherence tomography systems. Retina. 2011;31(1):48–55. [PubMed: 20683379]
86.: Tangelder GJ, Van der Heijde RG, Polak BC, Ringens PJ. Precision and reliability of retinal thickness measurements in foveal and extrafoveal areas of healthy and diabetic eyes. Invest Ophthalmol Vis Sci. 2008;49(6):2627–2634. [PubMed: 18515592]
87.: Mangione CM, Lee PP, Pitts J, et al. Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). Arch Ophthalmol. 1998;116(11):1496–1504. [PubMed: 9823352]
88.: Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009;50(8):3629–3635. [PubMed: 19255158]
89.: Miskala PH, Hawkins BS, Mangione CM, et al. Responsiveness of the National Eye Institute Visual Function Questionnaire to changes in visual acuity: findings in patients with subfoveal choroidal neovascularization-SST report no. 1. Arch Ophthalmol. 2003;121(4):531–539. [PMC free article: PMC1434793] [PubMed: 12695250]
90.: Orr P, Rentz AM, Margolis MK, et al. Validation of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011;52(6):3354–3359. [PubMed: 21282568]
91.: Revicki DA, Rentz AM, Harnam N, Thomas VS, Lanzetta P. Reliability and validity of the National Eye Institute Visual Function Questionnaire-25 in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2010;51(2):712–717. [PubMed: 19797233]
92.: Allergan Inc. response to October 30, 2017 CDR request for additional information regarding the Ozurdex (dexamethasone) CDR review: details of the dexamethasone single technology appraisal [CONFIDENTIAL additional manufacturer’s information]. Markham (ON): Allergan Inc.; 2017.
93.: Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value in Health. 2011;14(4):417–428. [PubMed: 21669366]
94.: Guidance document on reporting indirect comparisons. Ottawa: CADTH; 2015: https://www.cadth.ca/sites/default/files/pdf/MH0003_Guidance_on_IDC_Reporting.pdf. Accessed 2017 Dec 7.
95.: Callanan DG, Loewenstein A, Patel SS, et al. 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. [PubMed: 27632215]
96.: Gillies MC, Lim LL, Campain A, et al. A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study. Ophthalmology. 2014;121(12):2473–2481. [PubMed: 25155371]
97.: Fraser-Bell S, Lim LL, Campain A, et al. Bevacizumab or dexamethasone implants for DME: 2-year results (the BEVORDEX study). Ophthalmology. 2016;123(6):1399–1401. [PubMed: 26783096]
98.: Maturi RK, Glassman AR, Liu D, et al. Effect of adding dexamethasone to continued ranibizumab treatment in patients with persistent diabetic macular edema: a DRCR network phase 2 randomized clinical trial. JAMA Ophthalmol. 2018;136(1):29–38. [PMC free article: PMC5833605] [PubMed: 29127949]

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK539251

Contents

< PrevNext >

PubReader
Print View
Cite this Page
Clinical Review Report: Dexamethasone (Ozurdex): (Allergan Inc.): Indication: For the treatment of adult patients with diabetic macular edema who are pseudophakic [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Nov. References.
PDF version of this title (2.0M)