New Approaches for the Treatment of Diabetic Macular Edema
New Approaches for the Treatment of Diabetic Macular Edema
Patients with diabetes face various potential systemic complications, in addition to eye disease, particularly an increased risk for cardiovascular events. The safety and tolerability of new therapies in DME is therefore of critical importance.
Clinical studies have consistently demonstrated a favourable safety and tolerability profile with ranibizumab in patients with DME, with no imbalances in the rates of serious adverse events (SAEs) between ranibizumab treatment and control arms. Ocular SAEs with ranibizumab monotherapy were reported in four (3.9%) patients over 1 year in RESOLVE, with none reported in RESTORE (at 1 year) or READ-2 (at 6 months). Ocular SAEs with ranibizumab combined with laser were reported in two (1.7%) patients in RESTORE. There was a low incidence of endophthalmitis in ranibizumab treatment arms, with no cases in READ-2 or RESTORE, two cases in RESOLVE, and two cases during 1 year of treatment in DRCR.net protocol I (one in each of the ranibizumab arms).
In both RESOLVE and RESTORE, non-ocular SAEs were well balanced between ranibizumab and control groups. The incidence of non-ocular SAEs was 13.7 and 12.2% in the ranibizumab monotherapy and sham groups of RESOLVE, respectively, and 12.2, 5.8, and 10% in the ranibizumab monotherapy, combination, and laser monotherapy arms in RESTORE, respectively. There was no indication of an increased rate of cardiovascular or cerebrovascular events in ranibizumab groups vs controls.
Safety
Patients with diabetes face various potential systemic complications, in addition to eye disease, particularly an increased risk for cardiovascular events. The safety and tolerability of new therapies in DME is therefore of critical importance.
Clinical studies have consistently demonstrated a favourable safety and tolerability profile with ranibizumab in patients with DME, with no imbalances in the rates of serious adverse events (SAEs) between ranibizumab treatment and control arms. Ocular SAEs with ranibizumab monotherapy were reported in four (3.9%) patients over 1 year in RESOLVE, with none reported in RESTORE (at 1 year) or READ-2 (at 6 months). Ocular SAEs with ranibizumab combined with laser were reported in two (1.7%) patients in RESTORE. There was a low incidence of endophthalmitis in ranibizumab treatment arms, with no cases in READ-2 or RESTORE, two cases in RESOLVE, and two cases during 1 year of treatment in DRCR.net protocol I (one in each of the ranibizumab arms).
In both RESOLVE and RESTORE, non-ocular SAEs were well balanced between ranibizumab and control groups. The incidence of non-ocular SAEs was 13.7 and 12.2% in the ranibizumab monotherapy and sham groups of RESOLVE, respectively, and 12.2, 5.8, and 10% in the ranibizumab monotherapy, combination, and laser monotherapy arms in RESTORE, respectively. There was no indication of an increased rate of cardiovascular or cerebrovascular events in ranibizumab groups vs controls.
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