Background and Importance Therapy approved for diabetic macular oedema (DME) are intravitreal ranibizumab (IR), intravitreal aflibercept (IA) and dexamethasone intravitreal (ID). Currently there is a gap of information on its use in unresponsive to previous treatment.
Aim and Objectives To evaluate clinical effectiveness and safety of aflibercept or ranibizumab (Anti-VEGF) therapy for resistant macular oedema.
Material and Methods An observational retrospective study of all patients with DME unresponsive to previous anti-VEGF therapy from September 2021 to September 2022. Clinical data were obtained from digital clinical history and the prescription software: sex, aged, pathology, previous therapy, type treatment, number injections during study, response and adverse events (AE).
Effectiveness was determined by complete or partial response. Complete response was defined as maintenance of visual acuity (VA) reduction of subretinal fluid and inflammatory activity. Secondly, partial response was considered if only one of these parameters was observed. In terms of safety, adverse events (AE) were recorded.
Results Thirty-four patients, 53% women (n=18), were included, with an average aged of 69 (35-90) years. The population was patients diagnosed with resistant macular oedema. Almost all patients received treatment with one-line anti-VEGF therapy (80% aflibercept, 20% ranibizumab), only one patient received treatment with two lines anti-VEGF (bevacizumab and ranibizumab). During the study, 261 injections of IR (median 9, range 3-12) were administered into 32 eyes corresponding to 27 patients and 35 injections of IA (median 5, 2-7) were administered into 9 eyes corresponding to 7 patients. 12% (n=4) for patients who received combined therapy with ID. Complete response was observed in 27% patients (n=9), partial response in 26% (n=8) and non-response 47% (n=17).
No treatment-associated adverse effects were observed.
Conclusion and Relevance
The effectiveness was relatively low in unresponsive to previous treatment. Future controlled trials are needed to confirm the use of this type of treatments in unresponsive patients.
The safety profile for use of the therapy showed it was tolerated.
Conflict of Interest No conflict of interest
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