Real-world visual acuity outcomes between ranibizumab and aflibercept in treatment of neovascular AMD in a large US data set

Abstract

PurposeTo examine 12-month real-world visual acuity outcomes and treatment patterns in neovascular age-related macular degeneration (nAMD) eyes, including those with pigment epithelial detachment (PED), receiving ranibizumab or aflibercept.Patients and methodsElectronic medical records were used to identify ranibizumab or aflibercept-treated nAMD eyes with 12 months follow-up from first prescription. The primary objective was to compare mean change in visual acuity (VA) between index and month 12, in eyes treated with ranibizumab and aflibercept to assess the non-inferiority of ranibizumab vs aflibercept using a −5 letter non-inferiority margin. The number of injections and non-injection visits during follow-up were key secondary objectives.ResultsA total of 3350 ranibizumab and 4300 aflibercept treatment-naive eyes were included. At month 12, mean change from index in VA letter score was −0.30 for ranibizumab and −0.19 for aflibercept (P=0.81). The adjusted difference of mean change was −0.14 (−0.79 to 0.51) (P=0.67) (generalized estimating equations method) confirming the non-inferiority of ranibizumab. Eyes received a similar number of injections during follow-up. The mean (±SD) number of ranibizumab and aflibercept injections were 6.70 (±2.54) and 7.00 (±2.40), respectively (P<0.0001). In PED eyes, the mean (±SD) change between baseline to month 12 was 1.25 (±11.3) for ranibizumab and −0.39 (±13.3) for aflibercept (adjusted between-group difference 1.80 (−0.71 to 4.30; P=0.16)) achieved with a mean (±SD) 7.85 (±2.68) ranibizumab and 7.47 (±2.45) aflibercept injections, (P=0.11).ConclusionsRanibizumab and aflibercept treatment yielded comparable VA outcomes in nAMD eyes, including those with PED, with similar treatment patterns over 12 months in real-world clinical practice.

Real‐world visual outcomes in patients with neovascular age‐related macular degeneration receiving aflibercept at fixed intervals as per UK licence

“…This highlights that a relatively small reduction in injection numbers from the VIEW protocol can result in worse visual outcomes. A recent large retrospective US real‐world dataset of 4300 treatment‐naïve eyes identified a mean vision loss of 0.30 letters (SD 14.8) over 12 months (mean baseline VA, 58.5 letters) with eyes receiving a mean of seven aflibercept injections (SD 2.4) over that time period . The 12 month visual outcomes between the 2Q4 (12 injections) and 2Q8 (eight injections) aflibercept arms were similar in the VIEW 1 and 2 clinical trials, however the data here suggest that there can be a significant decline in visual outcomes with a further reduction in injection frequency, especially when fewer than seven injections are delivered in year 1 .…”

One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration

“…The advent of electronic medical records (EMR) has facilitated the collection of large amounts of data in routine clinical practice and thus has the potential to make retrospective study populations more representative of real life. (13)(14)(15)(16)(17)(18) were merged into the current centralised repository, the data warehouse. We have created a dataset from this which represents, to our knowledge, the largest single-center cohort of patients receiving treatment for neovascular AMD in the world.…”

“…The advent of electronic medical records (EMR) has facilitated the collection of large amounts of data in routine clinical practice and thus has the potential to make retrospective study populations more representative of real life. (13)(14)(15)(16)(17)(18) This is very much dependent, however, on the quality of data entry and the reliable follow-up of patients, and so these issues can remain problematic. The amount of data available from EMR systems also challenges the traditional methods of validation, analytics and reporting, and there is a struggle to implement the existing clinical research guidelines.…”

“…Secondary outcomes included the number of injections, and effect of baseline characteristics and injection numbers on changes in VA. Definitions for one-year and twoyear outcome dates were taken from previous real-world studies as visits closest to 52 weeks and 104 weeks post baseline date within ±8 weeks (6,13). We used the STROBE cohort checklist when writing our report (20).…”

The Moorfields AMD Database Report 2 - Fellow Eye Involvement with Neovascular Age-related Macular Degeneration

“…Secondary outcomes included the number of injections and time to involvement of fellow eyes. Definitions for one-year and two-year outcome dates were taken from previous real-world studies as visits closest to 52 weeks and 104 weeks post baseline date within ±8 weeks [21,22]. The data were analysed using the statistics software R (https://www.r-project.org/; provided in the public domain by R Core team 2017 R Foundation for Statistical Computing, Vienna, Austria).…”