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

Purpose: 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 w...

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Published in:Clinical ophthalmology (Auckland, N.Z.) N.Z.), 2022-01, Vol.16, p.2579-2593
Main Authors: Rouvas, Alexandras, Datseris, Ioannis, Androudi, Sofia, Tsilimbaris, Miltiadis, Kabanarou, Stamatina A, Pharmakakis, Nikolaos, Koutsandrea, Chryssanthi, Charonis, Alexander, Pantelopoulou, Olga Kousidou Georgia
Format: Article
Language:English
Subjects:
best corrected visual acuity
Care and treatment
central retinal thickness
Diabetic retinopathy
Enrollments
Macular degeneration
Monoclonal antibodies
Ophthalmic drugs
Ophthalmology
Original Research
Patients
Pharmaceutical industry
Physiological aspects
pigment epithelial detachment
Safety and security measures
Statistical analysis
Vascular endothelial growth factor
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Summary:Purpose: 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 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[+ or -]10.0 letters; median: 0.0; p = 0.002]; PED greatest basal diameter (GBD; median: 1470.5 [micro]m) also decreased (median decrease: 114.0 [micro]m; p = 0.019). Baseline central retinal thickness (CRT; median: 312.0 [micro]m) 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
ISSN:1177-5483
1177-5467
1177-5483
DOI:10.2147/OPTH.S371036