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Erschienen in: Graefe's Archive for Clinical and Experimental Ophthalmology 8/2015

01.08.2015 | Retinal Disorders

Intravitreal Ranibizumab for neovascular Age-related macular degeneration in clinical practice: five-year treatment outcomes

verfasst von: Meidong Zhu, Jamie K. Chew, Geoffrey K. Broadhead, Kehui Luo, Nichole Joachim, Thomas Hong, Adil Syed, Andrew A. Chang

Erschienen in: Graefe's Archive for Clinical and Experimental Ophthalmology | Ausgabe 8/2015

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Abstract

Background

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents are the established standard of care for neovascular age-related macular degeneration (nAMD). However, data on long-term outcomes of this therapy are limited. The purpose of this study was to assess the visual and anatomical outcomes and safety profile of intravitreal ranibizumab in treating nAMD over a period of five years.

Methods

208 patients (208 eyes) were included in this retrospective case series study. Intervention was an “as-needed” treatment model. Visual acuity (VA), central macular thickness (CMT), ophthalmic examination, and adverse events (AEs) were assessed in each visit. Snellen VA was converted to Early Treatment Diabetic Retinopathy Study letters for analysis.

Results

The average VA improved by 1.9 letters after one year (p = 0.017), and decreased by 2.4 letters over five years of treatment (p = 0.043). At the end of year five, 11.1 % of patients (23/208) had improved VA by more than 15 letters and 68.8 % (143/208) had VA improvement or loss less than or equal to 15 letters, while 20.2 % of patients (42/208) had a loss of more than 15 letters. Patients with VA of less than 35 letters at baseline showed significant VA improvement after five years of treatment. There was a positive relationship between injection numbers and VA improvement over the five-year period, after adjusting for age and baseline VA (p < 0.0005). Mean CMT decreased by 28.3 μm (p < 0.0005) over five years. Ocular AEs, serious adverse events (SAEs), and systemic SAEs occurred in 4.6 %, 0.48 %, and 2 % of patients, respectively, during the follow-up period.

Conclusions

The use of intravitreal ranibizumab in an as-needed treatment regimen over a five-year period was effective in maintaining vision in patients with nAMD and in reducing macular thickness, with a relatively low rate of adverse and serious adverse events.
Literatur
1.
Zurück zum Zitat Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine JB (2011) Prevalence of age-related macular degeneration in the US population. Arch Ophthalmol 129(1):75–80PubMedCrossRef Klein R, Chou CF, Klein BE, Zhang X, Meuer SM, Saaddine JB (2011) Prevalence of age-related macular degeneration in the US population. Arch Ophthalmol 129(1):75–80PubMedCrossRef
2.
Zurück zum Zitat Lim LS, Mitchell P, Seddon JM, Holz FG, Wong TY (2012) Age-related macular degeneration. Lancet 379(9827):1728–1738PubMedCrossRef Lim LS, Mitchell P, Seddon JM, Holz FG, Wong TY (2012) Age-related macular degeneration. Lancet 379(9827):1728–1738PubMedCrossRef
3.
Zurück zum Zitat Wong TY, Chakravarthy U, Klein R, Mitchell P, Zlateva G, Buggage R, Fahrbach K, Probst C, Sledge I (2008) The natural history and prognosis of neovascular age-related macular degeneration: a systematic review of the literature and meta-analysis. Ophthalmology 115(1):116–126PubMedCrossRef Wong TY, Chakravarthy U, Klein R, Mitchell P, Zlateva G, Buggage R, Fahrbach K, Probst C, Sledge I (2008) The natural history and prognosis of neovascular age-related macular degeneration: a systematic review of the literature and meta-analysis. Ophthalmology 115(1):116–126PubMedCrossRef
4.
Zurück zum Zitat Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY (2006) Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355(14):1419–1431PubMedCrossRef Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY (2006) Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355(14):1419–1431PubMedCrossRef
5.
Zurück zum Zitat Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T (2009) Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology 116(1):57–65 e55PubMedCrossRef Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T (2009) Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology 116(1):57–65 e55PubMedCrossRef
6.
Zurück zum Zitat Mitchell P, Korobelnik JF, Lanzetta P, Holz FG, Prunte C, Schmidt-Erfurth U, Tano Y, Wolf S (2010) Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials. Br J Ophthalmol 94(1):2–13PubMedCrossRef Mitchell P, Korobelnik JF, Lanzetta P, Holz FG, Prunte C, Schmidt-Erfurth U, Tano Y, Wolf S (2010) Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials. Br J Ophthalmol 94(1):2–13PubMedCrossRef
7.
Zurück zum Zitat Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW Jr, Esquiabro M (2009) A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol 148(1):43–58 e41PubMedCrossRef Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW Jr, Esquiabro M (2009) A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol 148(1):43–58 e41PubMedCrossRef
8.
Zurück zum Zitat Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC (2012) Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology 119(7):1399–1411PubMedCrossRef Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC (2012) Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology 119(7):1399–1411PubMedCrossRef
9.
Zurück zum Zitat Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL 3rd (2012) Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 119(7):1388–1398PubMedCentralPubMedCrossRef Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, Toth C, Redford M, Ferris FL 3rd (2012) Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 119(7):1388–1398PubMedCentralPubMedCrossRef
10.
Zurück zum Zitat Pushpoth S, Sykakis E, Merchant K, Browning AC, Gupta R, Talks SJ (2012) Measuring the benefit of 4 years of intravitreal ranibizumab treatment for neovascular age-related macular degeneration. Br J Ophthalmol 96(12):1469–1473PubMedCrossRef Pushpoth S, Sykakis E, Merchant K, Browning AC, Gupta R, Talks SJ (2012) Measuring the benefit of 4 years of intravitreal ranibizumab treatment for neovascular age-related macular degeneration. Br J Ophthalmol 96(12):1469–1473PubMedCrossRef
11.
Zurück zum Zitat Krüger Falk M, Kemp H, Sorensen TL (2013) Four-year treatment results of neovascular age-related macular degeneration with ranibizumab and causes for discontinuation of treatment. Am J Ophthalmol 155(1):89–95 e83PubMedCrossRef Krüger Falk M, Kemp H, Sorensen TL (2013) Four-year treatment results of neovascular age-related macular degeneration with ranibizumab and causes for discontinuation of treatment. Am J Ophthalmol 155(1):89–95 e83PubMedCrossRef
12.
Zurück zum Zitat Rasmussen A, Bloch SB, Fuchs J, Hansen LH, Larsen M, Lacour M, Lund-Andersen H, Sander B (2013) A 4-Year Longitudinal Study of 555 Patients Treated with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology Rasmussen A, Bloch SB, Fuchs J, Hansen LH, Larsen M, Lacour M, Lund-Andersen H, Sander B (2013) A 4-Year Longitudinal Study of 555 Patients Treated with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology
13.
Zurück zum Zitat Schachat AP (2013) Switching anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration. Am J Ophthalmol 156(1):1–2 e1PubMedCrossRef Schachat AP (2013) Switching anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration. Am J Ophthalmol 156(1):1–2 e1PubMedCrossRef
14.
Zurück zum Zitat Wolf-Schnurrbusch UE, Ceklic L, Brinkmann CK, Iliev ME, Frey M, Rothenbuehler SP, Enzmann V, Wolf S (2009) Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci 50(7):3432–3437PubMedCrossRef Wolf-Schnurrbusch UE, Ceklic L, Brinkmann CK, Iliev ME, Frey M, Rothenbuehler SP, Enzmann V, Wolf S (2009) Macular thickness measurements in healthy eyes using six different optical coherence tomography instruments. Invest Ophthalmol Vis Sci 50(7):3432–3437PubMedCrossRef
15.
Zurück zum Zitat Chang AA, Li H, Broadhead GK, Hong T, Schlub TE, Wijeyakumar W, Zhu M (2014) Intravitreal Aflibercept for Treatment-Resistant Neovascular Age-related Macular Degeneration. Ophthalmology 121(1):188–192PubMedCrossRef Chang AA, Li H, Broadhead GK, Hong T, Schlub TE, Wijeyakumar W, Zhu M (2014) Intravitreal Aflibercept for Treatment-Resistant Neovascular Age-related Macular Degeneration. Ophthalmology 121(1):188–192PubMedCrossRef
16.
Zurück zum Zitat Joeres S, Tsong JW, Updike PG, Collins AT, Dustin L, Walsh AC, Romano PW, Sadda SR (2007) Reproducibility of quantitative optical coherence tomography subanalysis in neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci 48(9):4300–4307PubMedCrossRef Joeres S, Tsong JW, Updike PG, Collins AT, Dustin L, Walsh AC, Romano PW, Sadda SR (2007) Reproducibility of quantitative optical coherence tomography subanalysis in neovascular age-related macular degeneration. Invest Ophthalmol Vis Sci 48(9):4300–4307PubMedCrossRef
17.
Zurück zum Zitat Krebs I, Hagen S, Smretschnig E, Womastek I, Brannath W, Binder S (2012) Reproducibility of segmentation error correction in age-related macular degeneration: Stratus versus Cirrus OCT. Br J Ophthalmol 96(2):271–275PubMedCrossRef Krebs I, Hagen S, Smretschnig E, Womastek I, Brannath W, Binder S (2012) Reproducibility of segmentation error correction in age-related macular degeneration: Stratus versus Cirrus OCT. Br J Ophthalmol 96(2):271–275PubMedCrossRef
18.
Zurück zum Zitat Hatef E, Khwaja A, Rentiya Z, Ibrahim M, Shulman M, Turkcuoglu P, Sepah Y, Wang J, Channa R, Bittencourt M, Akhtar A, Heo J, Do DV, Nguyen QD (2012) Comparison of time domain and spectral domain optical coherence tomography in measurement of macular thickness in macular edema secondary to diabetic retinopathy and retinal vein occlusion. J Ophthalmol 2012:354783PubMedCentralPubMed Hatef E, Khwaja A, Rentiya Z, Ibrahim M, Shulman M, Turkcuoglu P, Sepah Y, Wang J, Channa R, Bittencourt M, Akhtar A, Heo J, Do DV, Nguyen QD (2012) Comparison of time domain and spectral domain optical coherence tomography in measurement of macular thickness in macular edema secondary to diabetic retinopathy and retinal vein occlusion. J Ophthalmol 2012:354783PubMedCentralPubMed
19.
Zurück zum Zitat Gregori NZ, Feuer W, Rosenfeld PJ (2010) Novel method for analyzing snellen visual acuity measurements. Retina 30(7):1046–1050PubMedCrossRef Gregori NZ, Feuer W, Rosenfeld PJ (2010) Novel method for analyzing snellen visual acuity measurements. Retina 30(7):1046–1050PubMedCrossRef
20.
Zurück zum Zitat Velez-Montoya R, Oliver SC, Olson JL, Fine SL, Mandava N, Quiroz-Mercado H (2013) Current knowledge and trends in age-related macular degeneration: today's and future treatments. Retina 33(8):1487–1502PubMedCrossRef Velez-Montoya R, Oliver SC, Olson JL, Fine SL, Mandava N, Quiroz-Mercado H (2013) Current knowledge and trends in age-related macular degeneration: today's and future treatments. Retina 33(8):1487–1502PubMedCrossRef
21.
Zurück zum Zitat Golbaz I, Ahlers C, Stock G, Schutze C, Schriefl S, Schlanitz F, Simader C, Prunte C, Schmidt-Erfurth UM (2011) Quantification of the therapeutic response of intraretinal, subretinal, and subpigment epithelial compartments in exudative AMD during anti-VEGF therapy. Invest Ophthalmol Vis Sci 52(3):1599–1605PubMedCrossRef Golbaz I, Ahlers C, Stock G, Schutze C, Schriefl S, Schlanitz F, Simader C, Prunte C, Schmidt-Erfurth UM (2011) Quantification of the therapeutic response of intraretinal, subretinal, and subpigment epithelial compartments in exudative AMD during anti-VEGF therapy. Invest Ophthalmol Vis Sci 52(3):1599–1605PubMedCrossRef
22.
Zurück zum Zitat Brown DM, Tuomi L, Shapiro H (2013) Anatomical measures as predictors of visual outcomes in ranibizumab-treated eyes with neovascular age-related macular degeneration. Retina 33(1):23–34PubMedCrossRef Brown DM, Tuomi L, Shapiro H (2013) Anatomical measures as predictors of visual outcomes in ranibizumab-treated eyes with neovascular age-related macular degeneration. Retina 33(1):23–34PubMedCrossRef
23.
Zurück zum Zitat Folgar FA, Jaffe GJ, Ying GS, Maguire MG, Toth CA, Comparison of Age-Related Macular Degeneration Treatments Trials Research Group (2014) Comparison of Optical Coherence Tomography Assessments in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology Folgar FA, Jaffe GJ, Ying GS, Maguire MG, Toth CA, Comparison of Age-Related Macular Degeneration Treatments Trials Research Group (2014) Comparison of Optical Coherence Tomography Assessments in the Comparison of Age-Related Macular Degeneration Treatments Trials. Ophthalmology
24.
Zurück zum Zitat Giani A, Cigada M, Choudhry N, Deiro AP, Oldani M, Pellegrini M, Invernizzi A, Duca P, Miller JW, Staurenghi G (2010) Reproducibility of retinal thickness measurements on normal and pathologic eyes by different optical coherence tomography instruments. Am J Ophthalmol 150(6):815–824PubMedCrossRef Giani A, Cigada M, Choudhry N, Deiro AP, Oldani M, Pellegrini M, Invernizzi A, Duca P, Miller JW, Staurenghi G (2010) Reproducibility of retinal thickness measurements on normal and pathologic eyes by different optical coherence tomography instruments. Am J Ophthalmol 150(6):815–824PubMedCrossRef
25.
Zurück zum Zitat CATT Research Group, Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ (2011) Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 364(20):1897–1908CrossRef CATT Research Group, Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ (2011) Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 364(20):1897–1908CrossRef
26.
Zurück zum Zitat Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307–310PubMedCrossRef Bland JM, Altman DG (1986) Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1(8476):307–310PubMedCrossRef
27.
Zurück zum Zitat Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U (2012) Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 119(12):2537–2548PubMedCrossRef Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U (2012) Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 119(12):2537–2548PubMedCrossRef
28.
Zurück zum Zitat Abell RG, Kerr NM, Allen P, Vote BJ (2012) Intravitreal injections: is there benefit for a theatre setting? Br J Ophthalmol 96(12):1474–1478PubMedCrossRef Abell RG, Kerr NM, Allen P, Vote BJ (2012) Intravitreal injections: is there benefit for a theatre setting? Br J Ophthalmol 96(12):1474–1478PubMedCrossRef
29.
Zurück zum Zitat Brynskov T, Kemp H, Sorensen TL (2014) No cases of endophthalmitis after 20,293 intravitreal injections in an operating room setting. Retina 34(5):951–957PubMedCrossRef Brynskov T, Kemp H, Sorensen TL (2014) No cases of endophthalmitis after 20,293 intravitreal injections in an operating room setting. Retina 34(5):951–957PubMedCrossRef
Metadaten
Titel
Intravitreal Ranibizumab for neovascular Age-related macular degeneration in clinical practice: five-year treatment outcomes
verfasst von
Meidong Zhu
Jamie K. Chew
Geoffrey K. Broadhead
Kehui Luo
Nichole Joachim
Thomas Hong
Adil Syed
Andrew A. Chang
Publikationsdatum
01.08.2015
Verlag
Springer Berlin Heidelberg
Erschienen in
Graefe's Archive for Clinical and Experimental Ophthalmology / Ausgabe 8/2015
Print ISSN: 0721-832X
Elektronische ISSN: 1435-702X
DOI
https://doi.org/10.1007/s00417-014-2799-8

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