Dataset Information

Factors Influencing Response to Aflibercept in Diabetic Macular Oedema Patients in a Diverse North West London Population: A Real-World Study.

ABSTRACT:

Background

Diabetic macular oedema (DMO) is the leading cause of sight impairment in working age populations in developed countries. Current first line treatment for centre-involving DMO involves intravitreal anti-VEGF but treatment response can be variable. In this retrospective, real world, multi-centre cohort study, we aim to identify ocular and systemic characteristics that correlate with anatomical and functional outcomes for treatment-naive DMO patients treated with intravitreal aflibercept.

Methods

Retrospective multicentre cohort study of treatment-naive DMO patients initiated on aflibercept at three North West London hospitals between 2016 and 2018. Baseline systemic and ocular factors, best corrected visual acuity (BCVA) and central macular thickness (CMT) at 12 months were determined and statistically analysed.

Results

A total of 270 eyes of 221 DMO patients met inclusion criteria. Mean age was 62.8 ± 12.1, mean baseline HbA1c was 67 ± 20 mmol/mol, and mean eGFR was 72 mL/min/1.7m². Mean number of aflibercept injections at 12 months was 6.2. Better baseline BCVA, lower baseline CMT, and absence of epiretinal membrane (ERM) were associated with better BCVA at 12 months whilst lower baseline CMT and proliferative retinopathy status were associated with lower CMT at 12 months.

Conclusion

Our study is the largest real-world dataset examining factors influencing functional and anatomical response to aflibercept in DMO in the UK. Older age, lower baseline BCVA, higher baseline CMT and more severe diabetic retinopathy were associated with poorer visual acuity at 12 months and prioritisation of these patients within a pressured healthcare setting is recommended.

SUBMITTER: Sim SY

PROVIDER: S-EPMC8144175 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown.MethodsAt 89 clinical sites, we randomly assigned 660 adults (mean age, 61±10 years) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg (224 participants), bevacizumab at a dose of 1.25 mg (218 participants), or ranibizumab at a dose of 0.3 mg (218 participants). The study drugs were administered as often as every 4 weeks, according to a protocol-specified algorithm. The primary outcome was the mean change in visual acuity at 1 year.ResultsFrom baseline to 1 year, the mean visual-acuity letter score (range, 0 to 100, with higher scores indicating better visual acuity; a score of 85 is approximately 20/20) improved by 13.3 with aflibercept, by 9.7 with bevacizumab, and by 11.2 with ranibizumab. Although the improvement was greater with aflibercept than with the other two drugs (P<0.001 for aflibercept vs. bevacizumab and P=0.03 for aflibercept vs. ranibizumab), it was not clinically meaningful, because the difference was driven by the eyes with worse visual acuity at baseline (P<0.001 for interaction). When the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with aflibercept, 7.5 with bevacizumab, and 8.3 with ranibizumab (P>0.50 for each pairwise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with aflibercept, 11.8 with bevacizumab, and 14.2 with ranibizumab (P<0.001 for aflibercept vs. bevacizumab, P=0.003 for aflibercept vs. ranibizumab, and P=0.21 for ranibizumab vs. bevacizumab). There were no significant differences among the study groups in the rates of serious adverse events (P=0.40), hospitalization (P=0.51), death (P=0.72), or major cardiovascular events (P=0.56).ConclusionsIntravitreous aflibercept, bevacizumab, or ranibizumab improved vision in eyes with center-involved diabetic macular edema, but the relative effect depended on baseline visual acuity. When the initial visual-acuity loss was mild, there were no apparent differences, on average, among study groups. At worse levels of initial visual acuity, aflibercept was more effective at improving vision. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01627249.).