Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study

被引：27

作者：

Gale, Richard P. ^{[1
]}

Pearce, Ian ^{[2
]}

Eter, Nicole ^{[3
]}

Ghanchi, Faruque ^{[4
]}

Holz, Frank G. ^{[5
]}

Schmitz-Valckenberg, Steffen ^{[5
]}

Balaskas, Konstantinos ^{[6
]}

Burton, Ben J. L. ^{[7
,8
]}

Downes, Susan M. ^{[9
]}

Eleftheriadis, Haralabos ^{[10
]}

George, Sheena ^{[11
,12
]}

Gilmour, David ^{[13
]}

Hamilton, Robin

Lotery, Andrew J. ^{[14
]}

Patel, Nishal ^{[15
]}

Prakash, Priya ^{[16
]}

Santiago, Cynthia ^{[17
]}

Thomas, Saju ^{[18
]}

Varma, Deepali ^{[19
]}

Walters, Gavin ^{[20
]}

Williams, Michael ^{[21
,22
]}

Wolf, Armin ^{[23
]}

Zakri, Rosina H. ^{[15
]}

Igwe, Franklin ^{[24
]}

Ayan, Filis ^{[24
]}

机构：

[1] York Teaching Hosp NHS Fdn Trust, York YO31 8HE, N Yorkshire, England

[2] Royal Liverpool Univ Hosp, Liverpool, Merseyside, England

[3] Univ Munster, Dept Ophthalmol, Med Ctr, Munster, Germany

[4] Bradford Teaching Hosp NHS Trust, Bradford, W Yorkshire, England

[5] Univ Bonn, Dept Ophthalmol, GRADE Reading Ctr, Bonn, Germany

[6] Moorfields Eye Hosp NHS Fdn Trust, London, England

[7] James Paget Univ Hosp NHS Fdn Trust, Great Yarmouth, England

[8] Univ East Anglia, Norwich, Norfolk, England

[9] Oxford Univ Hosp NHS Fdn Trust, Oxford, England

[10] Kings Coll London, London, England

[11] Hillingdon Hosp NHS Fdn Trust, Uxbridge, Middx, England

[12] NW London Clin Res Network, London, England

[13] NHS Greater Glasgow & Clyde, Glasgow, Lanark, Scotland

[14] Univ Southampton, Fac Med, Southampton, Hants, England

[15] East Kent Hosp Univ NHS Fdn Trust, Canterbury, Kent, England

[16] Princess Alexandra Hosp NHS Trust, Harlow, Essex, England

[17] Aberdeen Royal Infirm, NHS Grampian, Aberdeen, Scotland

[18] Cty Durham & Darlington NHS Fdn Trust, Darlington, Durham, England

[19] City Hosp Sunderland NHS Fdn Trust, Sunderland, England

[20] Harrogate & Dist NHS Fdn Trust, Harrogate, England

[21] Queens Univ Belfast, Belfast, Antrim, North Ireland

[22] Belfast Hlth & Social Care Trust, Belfast, Antrim, North Ireland

[23] Univ Munich, Munich, Germany

[24] Novartis Pharmaceut UK Ltd, Surrey, England

来源：

BRITISH JOURNAL OF OPHTHALMOLOGY | 2020年 / 104卷 / 04期

关键词：

clinical trial; degeneration; imaging; macula; neovascularisation; ANTI-VEGF THERAPY; PREVALENCE; TACHYPHYLAXIS; BEVACIZUMAB; MANAGEMENT;

D O I：

10.1136/bjophthalmol-2019-314251

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

Background/Aims Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity. Methods SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed. Results One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of -30.75 mu m (95% CI -59.50,-20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0->= 15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (<= 2 letters). No new safety signals were identified. Conclusion Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with similar to 60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.

引用

页码：493 / 499

页数：7

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