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J. Garcia-Arumi, Resolve Study Group; Safety Profile of Diabetic Macular Edema Patients Treated Over 12 Months With Ranibizumab in the RESOLVE Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4248.
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Diabetic macular edema (DME) is an uncommon but significant cause of vision loss in diabetes mellitus. The elevated VEGF concentration in the vitreous of DME patients indicates its role in DME pathogenesis. RESOLVE is the first RCT to assess the 12-month safety and efficacy of ranibizumab in DME. Here, we present the detailed safety profile of ranibizumab treatment in DME patients.
151 DME patients were randomized to ranibizumab 6 mg/ml (n=51), 10 mg/ml (n=51), or sham injection (n=49). Three initial monthly injections were followed by re-treatment based on success, futility, or safety criteria. The safety profile of the pooled ranibizumab treatment groups were compared to the sham group based on the 12-month incidence of ocular and non-ocular AEs and SAEs.
The mean number of ranibizumab injections was 10.2 in the pooled ranibizumab groups vs. 8.9 in sham. Most commonly reported ocular AEs were conjunctival hemorrhage (ranibizumab 23%, sham 14%), transient post-injection increase of IOP (ranibizumab 21%, sham 2%), and eye pain (ranibizumab 18%, sham 20%). Most of these ocular AEs were suspected to be treatment-related. Nasopharyngitis was the most common non-ocular AE (ranibizumab 10%, sham 2%). Other non-ocular AEs were hypertension (ranibizumab 7%, sham 8%), anemia (ranibizumab 5%, sham 0%), and influenza (ranibizumab 5%, sham 2%). A minority of these non-ocular AEs were suspected to be treatment-related. AEs suspected to be related to systemic VEGF inhibition included arterial thromboembolic events (ranibizumab 3%, sham 4%), hypertension (ranibizumab 9%, sham 10%), and non-ocular hemorrhage (ranibizumab 2%, sham 0%). Ocular SAEs in the ranibizumab group included 2 cases of endophthalmitis and 1 case each of retinal artery occlusion and vitreous hemorrhage, which were considered treatment-related. Metabolism and nutrition disorders (ranibizumab 3%, sham 2%) were the most common non-ocular SAEs. There was 1 death in the ranibizumab group due to bladder cancer (suspected to be unrelated to study medication).
This safety analysis of the RESOLVE study showed that ranibizumab was well tolerated in DME patients. The described safety profile is similar to that reported for ranibizumab-treated AMD patients, with no new safety concerns.
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