The aim of APOLLON is to describe resource use, monitoring patterns, and outcomes in patients with diabetic macular oedema (DME) treated with intravitreal aflibercept (IVT-AFL) in routine clinical practice.
Name
014 - APOLLON: Etude prospective, observationnelle, évaluant la prise en charge, dans la pratique courante, des patients atteints d’œdème maculaire diabétique et initiant un traitement par injection intravitréenne d’aflibercept
Name
014 - APOLLON: Etude prospective, observationnelle, évaluant la prise en charge, dans la pratique courante, des patients atteints d’œdème maculaire diabétique et initiant un traitement par injection intravitréenne d’aflibercept
Orateurs :
Dr Pascale MASSIN
Résumé
Introduction
Patients et Methodes
This is an ongoing, prospective, observational study being conducted in 56 centres in France. Patients aged ≥18 years with type 1 or 2 diabetes mellitus and visual impairment due to DME were enrolled from September 2016 to July 2017. These patients were treatment-naïve or previously treated with anti-vascular endothelial growth factor (anti-VEGF) agents, laser, or steroids prior to IVT-AFL treatment. The primary outcome is the mean change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to Month 12. Secondary outcomes include the mean change in visual acuity at Month 24, mean change in central retinal thickness (CRT), other anatomical assessments (including absence of fluid), and safety outcomes at Months 12 and 24. Resource use (injections, treatment intervals, and visits) will also be monitored. Herein, we report the study design and baseline characteristics.
Résultats
A total of 346 patients were screened, and 267 were enrolled in the full analysis set (FAS), which included 130 treatment-naïve and 133 previously treated patients. The baseline characteristics are summarised in the Table. Overall, the mean (standard deviation [SD]) age was 66.0 (10.4) years, and mean (SD) BCVA was 59.9 (16.0) ETDRS letters. Baseline BCVA categories were ≤24 letters: 3.4%, 24–73 letters: 74.2%, and ≥73 letters: 22.5%. In the previously treated group, patients had received laser (any) (97.9%), steroids (34.1%), and anti-VEGF treatment other than IVT-AFL (92.9%); the majority of these patients received ranibizumab (96.2%) over a mean (SD) period of 301.8 (368.5) days.
| Variables | Treatment-naïve* | Previously treated* | Total |
| N | 130 | 133 | 267 |
| Age | 64.9 (11.2) | 66.9 (9.5) | 66.0 (10.4) |
| Male, n (%) | 65 (50.0) | 76 (57.1) | 144 (53.9) |
| Glycated haemoglobin (HbA1c) (%) | 7.8 (1.4) | 7.7 (1.3) | 7.7 (1.4) |
| BCVA, ETDRS letters | 61.9 (14.3) | 57.5 (17.3) | 59.9 (16.0) |
| CRT, µm | 443.6 (124.2) | 465.0 (140.3) | 453.3 (132.6) |
| Subretinal fluid, n (%) | 41 (34.7) | 27 (23.1) | 69 (29.1) |
| Intraretinal fluid, n (%) | 112 (94.1) | 114 (96.6) | 227 (95.0) |
Mean (SD) unless stated. *Data missing for 4 patients in total.
Discussion
Enrolment in APOLLON represents a typical population routinely treated in a real-world setting as shown by the baseline characteristics for naïve and previously treated patients.
Conclusion
APOLLON will assess real-world outcomes in treatment-naïve and previously treated patients with DME receiving IVT-AFL, to help inform clinical practice on the use of IVT-AFL in this setting.