Background and importance Intravitreal ranibizumab (IVR) and aflibercept (IVA) are approved for ophthalmology pathologies such as age related macular degeneration (AMD) and diabetic macular oedema (DME). Due to drug costs and high prevalence rates, there is a need to protocolise and rationalise the use of these drugs.
Aim and objectives To develop and implement a treatment algorithm and to evaluate the effectiveness and safety of IVR and IVA in a tertiary hospital.
Material and methods A group composed of ophthalmologists and pharmacists was created. An observational retrospective study was carried out including all patients treated with IVR and IVA from September 2017 to August 2018. Collected variables were gender, age, pathology, previous bevacizumab injections, response and adverse events. For IVR, complete response was defined as gain of visual acuity (VA) ≥5 letters or loss of foveal thickness from baseline values. For IVA, complete response was defined as gain/maintenance of VA, reduction of subretinal fluid and absence of inflammatory activity. Partial response was considered if only one of these parameters was observed. Responses were compared with pivotal clinical trials (PCT).
Results A treatment algorithm was developed and approved by the pharmacotherapeutic committee. IVR and IVA were positioned as secondline treatments after at least three bevacizumab injections. Overall, 75 injections of IVR (median 3 per patient, range 1–5) were administered into 29 eyes corresponding to 26 patients (30.8% women) with a median age of 68 years (range 40–87) affected by DME. Complete response was observed in 18 eyes (62.1% vs 42.5% in PCT), partial response in 5 (17.2%), non-response in 1 (3.4%) and follow-up loss in 5 (17.2%).
Regarding IVA, 283 injections (median 3, range 1–11) were administered into 77 eyes corresponding to 68 patients (52.9% women) with a median age of 78 years (range 48–98). All patients were affected by AMD. Complete response was observed in 51 eyes (66.2% vs 31.0% in PCT), partial response in 18 (23.4%), non-response in 4 (5.2%) and follow-up loss in 4 (5.2%). Median previous injections of bevacizumab were 7 for IVR and 8 for IVA. No serious adverse events were observed.
Conclusion and relevance The algorithm was implemented well in our hospital, achieving rational ophthalmic drug use. IVR and IVA are effective and safe, with better complete responses than those described in PCT.
References and/or acknowledgements No conflict of interest.
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