A Real-World, Multicenter, 6-Month Prospective Study in Greece of the Effectiveness and Safety of Ranibizumab in Patients with Age-Related Macular Degeneration Who Have Inadequately Responded to Aflibercept: The “ELEVATE” Study

Abstract

Alexandros Rouvas,1 Ioannis Datseris,2 Sofia Androudi,3 Miltiadis Tsilimbaris,4 Stamatina A Kabanarou,5 Nikolaos Pharmakakis,6 Chryssanthi Koutsandrea,7 Alexander Charonis,8 Olga Kousidou,9 Georgia Pantelopoulou9 1 2nd Department of Ophthalmology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece; 2OMMA Ophthalmological Institute of Athens, Athens, Greece; 3Ophthalmology Clinic, University of Thessaly, Larissa, Greece; 4Ophthalmological Clinic, University of Crete Medical School, Heraklion, Greece; 5Department of Ophthalmology, General Hospital of Athens ‘korgialenio-Benakio’, Athens, Greece; 6Department of Ophthalmology, University of Patras, Patras, Greece; 7Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece; 8Retina Service, Athens Vision Eye Institute, Athens, Greece; 9Medical Department, Novartis (Hellas), Athens, GreeceCorrespondence: Olga Kousidou, Medical Department, Novartis (Hellas), National Road No. 1 12th Km, Metamorphosis, Athens, GR-144 51, Greece, Tel [phone], Fax [phone], Email [email protected]: Real-world evidence on short-term outcomes of ranibizumab in wet age-related macular degeneration (wAMD) following inadequate response to aflibercept is scarce. This study aimed to evaluate the functional and anatomic effects of switching to ranibizumab in cases of wAMD previously treated with aflibercept with inadequate response.Patients and Methods: Prospective, observational study performed in eight ophthalmology hospital/private clinics in Greece, enrolling consented patients with active wAMD, ≥ 50 years-old, who had initiated ranibizumab ≥ 28 days and < 2 months after their last aflibercept injection. Data were collected at enrollment, and at 1, 3 and 6 months post-treatment onset (post-baseline).Results: Between September-2015 and November-2017, 103 eligible patients (56.3% females; mean age: 74.8± 8.6 years) were consecutively enrolled. The age at AMD diagnosis in the study eye was 71.3± 8.8 years. Aflibercept (median of 5 injections received over 11.3 months) had been discontinued for anatomical (in 69.9%) and/or functional (38.8%) reasons. At baseline (median: 24.3 months after wAMD diagnosis), choroidal neovascularization was occult in 69.1% of evaluable study eyes; 60.2% of the study eyes had pigment epithelial detachment (PED); 42.7% cysts; 21.4% fibrosis; 66.0% subretinal, and 59.2% intraretinal fluid. At 6 months post-baseline: a median of 3 ranibizumab injections (range: 1– 6) had been received; the best-corrected visual acuity (BCVA)≥ 0 letter gain rate was 81.8%; the BCVA ≥ 15 letter gain rate was 17.0%; BCVA gain was 3.2 letters [mean increase: 3.2± 10.0 letters; median: 0.0; p = 0.002]; PED greatest basal diameter (GBD; median: 1470.5 μm) also decreased (median decrease: 114.0 μm; p = 0.019). Baseline central retinal thickness (CRT; median: 312.0 μm) remained unchanged. One patient permanently discontinued ranibizumab due to adverse event occurrence, assessed as not causally related to ranibizumab. There were no ranibizumab-related adverse reactions.Conclusion: Six-month treatment with ranibizumab in aflibercept inadequate responders led to visual acuity and PED GBD improvements, with no statistically significant CRT change.Keywords: best corrected visual acuity, central retinal thickness, pigment epithelial detachment

Keywords

• best corrected visual acuity
• central retinal thickness
• pigment epithelial detachment