Hostname: page-component-78c5997874-s2hrs Total loading time: 0 Render date: 2024-11-11T14:29:13.658Z Has data issue: false hasContentIssue false
  • English
  • Français

COMPARATIVE EFFECTIVENESS OF ANTI-VEGF AGENTS FOR DIABETIC MACULAR EDEMA

Published online by Cambridge University Press:  02 December 2013

Daniel A. Ollendorf ,
Jennifer A. Colby  and
Steven D. Pearson
Daniel A. Ollendorf
Affiliation:
Institute for Clinical and Economic Review
Jennifer A. Colby
Affiliation:
Institute for Clinical and Economic Review
Steven D. Pearson
Affiliation:
Institute for Clinical and Economic Review
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: The aim of this study was to evaluate the comparative effectiveness of anti-vascular endothelial growth factor therapy in the treatment of diabetic macular edema (DME).

Methods: Searches focused on reports concerning treatment of DME with aflibercept, bevacizumab, pegaptanib, or ranibizumab published between January 2000 and June 30, 2012, with comparisons to laser photocoagulation, sham injection, or other control (e.g., triamcinolone). Effectiveness was based on best-corrected visual acuity (BCVA), in terms of letters gained. Direct meta-analyses were conducted on BCVA for each anti-vascular endothelial growth factor (VEGF) agent; indirect comparisons also were performed for each anti-VEGF pair.

Results: A total of fifteen randomized controlled trials (eleven fair- or good-quality) and eight observational studies were included. No direct comparative studies were identified. Improvement in visual acuity versus control was seen with all agents (range: 4–9 letters); outcomes were consistent across multiple timepoints. Meta-analyses showed no statistically significant and/or consistent differences between agents in BCVA changes or the percentage of patients gaining more than ten letters. No discernible differences in the potential harms of anti-VEGFs, including ocular events, MI, stroke, and other cardiovascular events, as well as death, were noted between aflibercept, pegaptanib, and ranibizumab. Data on harms for bevacizumab were underreported.

Conclusions: All anti-VEGF agents are effective in improving visual acuity in comparison to laser photocoagulation. Evidence is insufficient to distinguish the performance of any single anti-VEGF agent over others. The safety of bevacizumab remains the greatest element of uncertainty.

Keywords

Comparative effectiveness researchVascular endothelial growth factor AMacular edema
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 29 , Issue 4 , October 2013 , pp. 392 - 401
Copyright
Copyright © Cambridge University Press 2013 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Romero-Aroca, P. Targeting the pathophysiology of diabetic macular edema. Diabetes Care. 2010;33:2484–2485.CrossRefGoogle ScholarPubMed
2.Romero-Aroca, P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011;2:98–104.CrossRefGoogle ScholarPubMed
3.Lee, LJ, Yu, AP, Cahill, KE, et al.Direct and indirect costs among employees with diabetic retinopathy in the United States. Curr Med Res Opin. 2008;24:1549–1559.CrossRefGoogle ScholarPubMed
4.Wong, TY, Klein, R, Islam, FM, et al.Diabetic retinopathy in a multi-ethnic cohort in the United States. Am J Ophthalmol. 2006;141:446–455.CrossRefGoogle Scholar
5.Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study Group report number 1. Arch Ophthalmol. 1985;103:1796–1806.CrossRefGoogle Scholar
6.Morello, CM. Etiology and natural history of diabetic retinopathy: An overview. Am J Health Syst Pharm. 2007;64 (Suppl 12):S3–S7.CrossRefGoogle ScholarPubMed
7.Wong, TY, Mwamburi, M, Klein, R, et al.Rates of progression in diabetic retinopathy during different time periods: A systematic review and meta-analysis. Diabetes Care. 2009;32:2307–2313.CrossRefGoogle ScholarPubMed
8.Bibby, SA, Maslin, ER, McIlraith, R, Soong, GP. Vision and self-reported mobility performance in patients with low vision. Clin Exp Optom. 2007;90:115–123.CrossRefGoogle ScholarPubMed
9.Haymes, SA, Johnston, AW, Heyes, AD. Relationship between vision impairment and ability to perform activities of daily living. Ophthalmic Physiol Opt. 2002;22:79–91.CrossRefGoogle ScholarPubMed
10.Hazel, CA, Petre, KL, Armstrong, RA, et al.Visual function and subjective quality of life compared in subjects with acquired macular disease. Invest Ophthalmol Vis Sci. 2000;41:1309–1315.Google ScholarPubMed
11.Peters, CM, James, AI, Tran, I, et al.The impact of diabetic macular edema on the daily lives of diabetic adults—A qualitative study. Presented at: ARVO Annual Meeting, May 9, 2012, Ft. Lauderdale, Florida.Google Scholar
12.Cheung, N, Mitchell, P, Wong, TY. Diabetic retinopathy. Lancet. 2010;376:124–136.CrossRefGoogle ScholarPubMed
13.European Medicines Agency. Assessment report for ranibizumab (Lucentis). Procedure No.: EMEA/H/C/000715/II/0020. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000715/WC500101009.pdf. (accessed October 12, 2012).Google Scholar
14.Food and Drug Administration (FDA). FDA approves Lucentis to treat diabetic macular edema. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315130.htm. (accessed October 12, 2012).Google Scholar
15.Avery, RL, Pieramici, DJ, Rabena, MD, et al.Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology. 2006;113:363–372.CrossRefGoogle ScholarPubMed
16.Rosenfeld, PJ. Intravitreal Avastin: The low cost alternative to Lucentis? Am J Ophthalmol. 2006;142:141–143.CrossRefGoogle ScholarPubMed
17.Steinbrook, R. The price of sight – Ranibizumab, bevacizumab, and the treatment of macular degeneration. N Engl J Med. 2006;355:1409–1412.CrossRefGoogle Scholar
18.U.S. Preventive Services Task Force Procedure Manual. AHRQ Publication No. 08–05118-EF, July 2008. http://www.uspreventiveservicestaskforce.org/uspstf08/methods/procmanual.htm. (accessed June 23, 2012).Google Scholar
19.Holladay, JT. Proper method for calculating average visual acuity. J Refract Surg. 1997;13:388–391.CrossRefGoogle ScholarPubMed
20.Thomson, D. VA testing in optometric practice. Part 2: Newer chart designs. Optometry Today. 2005;45:22–24.Google Scholar
21.Beck, RW, Maguire, MG, Bressler, NM, et al.Visual acuity as an outcome measure in clinical trials of retinal diseases. Ophthalmology. 2007;114:1804–1809.CrossRefGoogle ScholarPubMed
22.Suñer, IJ, Kokame, GT, Yu, E, et al.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;50:3629–3635.CrossRefGoogle ScholarPubMed
23.Mangione, CM, Lee, PP, Gutierrez, PR, et al.Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001;119:1050–1058.CrossRefGoogle ScholarPubMed
24.Shaw, JW, Johnson, JA, Coons, SJ. U.S. valuation of the EQ-5D health states. Med Care. 2005;43:203–220.CrossRefGoogle ScholarPubMed
25.Cao, Y, Tan, A, Gao, F, et al.A meta-analysis of randomized controlled trials comparing chemotherapy plus bevacizumab with chemotherapy alone in metastatic colorectal cancer. Int J Colorectal Dis. 2009;24:677–685.CrossRefGoogle ScholarPubMed
26.Choueiri, TK, Mayer, EL, Je, Y, et al.Congestive heart failure risk in patients with breast cancer treated with bevacizumab. J Clin Oncol. 2011;29:632–638.CrossRefGoogle ScholarPubMed
27.Galfrascoli, E, Piva, S, Cinquini, M, et al.Risk/benefit profile of bevacizumab in metastatic colon cancer: A systematic review and meta-analysis. Dig Liver Dis. 2011;43:286–294.CrossRefGoogle ScholarPubMed
28.Geiger-Gritsch, S, Stollenwerk, B, Miksad, R, et al.Safety of bevacizumab in patients with advanced cancer: A meta-analysis of randomized controlled trials. Oncologist. 2010;15:1179–1191.CrossRefGoogle Scholar
29.Food and Drug Administration (FDA). Proposal to withdraw approval for the breast cancer indication for Avastin (bevacizumab) (docket no. FDA-2010-N-0621): Commissioner's decision, November 18, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm279485.htm. (accessed October 12, 2012).Google Scholar
30.Cooper, NJ, Sutton, AJ, Morris, D, et al.Addressing between-study heterogeneity and inconsistency in mixed treatment comparisons: Application to stroke prevention treatments in individuals with non-rheumatic atrial fibrillation. Stat Med. 2009;28:1861–81.CrossRefGoogle ScholarPubMed
31.Salanti, G, Marinho, V, Higgins, JPT. A case study of multiple-treatments meta-analysis demonstrates that covariates should be considered. J Clin Epidemiol. 2009;62:857–864.CrossRefGoogle ScholarPubMed
32.Centers for Medicare and Medicaid Services. January 2012 Medicare ASP pricing file. http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a17_2012ASPFiles.asp#TopOfPage. (accessed Jan 31, 2012).Google Scholar
33.Stein, JD, Newman-Casey, PA, Kim, DD, et al.Cost-effectiveness of various interventions for newly diagnosed diabetic macular edema. Ophthalmology. 2013; pii: S0161–6420(13)00121–8. doi: 10.1016/j.ophtha.2013.02.002. [Epub ahead of print].Google ScholarPubMed
Supplementary material: File

Kolasa et al. supplementary material

Supplementary table 3

Download Kolasa et al. supplementary material(File)
File 53.2 KB
Supplementary material: File

Ollendorf et al. supplementary material

Supplementary table 1

Download Ollendorf et al. supplementary material(File)
File 26.6 KB
Supplementary material: File

Ollendorf et al. supplementary material

Supplementary table 2

Download Ollendorf et al. supplementary material(File)
File 77.3 KB
Supplementary material: File

Ollendorf et al. supplementary material

Supplementary table 4

Download Ollendorf et al. supplementary material(File)
File 207.4 KB
Supplementary material: File

Ollendorf et al. supplementary material

Supplementary table 5

Download Ollendorf et al. supplementary material(File)
File 34.3 KB
Supplementary material: File

Ollendorf et al. supplementary material

Supplementary figures

Download Ollendorf et al. supplementary material(File)
File 77.8 KB