RT Journal Article
SR Electronic
T1 Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
SP 493
OP 499
DO 10.1136/bjophthalmol-2019-314251
VO 104
IS 4
A1 Richard P Gale
A1 Ian Pearce
A1 Nicole Eter
A1 Faruque Ghanchi
A1 Frank G Holz
A1 Steffen Schmitz-Valckenberg
A1 Konstantinos Balaskas
A1 Ben J L Burton
A1 Susan M Downes
A1 Haralabos Eleftheriadis
A1 Sheena George
A1 David Gilmour
A1 Robin Hamilton
A1 Andrew J Lotery
A1 Nishal Patel
A1 Priya Prakash
A1 Cynthia Santiago
A1 Saju Thomas
A1 Deepali Varma
A1 Gavin Walters
A1 Michael Williams
A1 Armin Wolf
A1 Rosina H Zakri
A1 Franklin Igwe
A1 Filis Ayan
YR 2020
UL http://bjo.bmj.com/content/104/4/493.abstract
AB 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 µm (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 ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab.