No abstract

To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. Patients and methods A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (�18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (�4 and �5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients. Results Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections.

This study was conducted on 34 children with chronic renal failure: 27 on regular haemodialysis and seven on conservative treatment. Twenty normal healthy children served as controls. They were subjected to clinical examination including otoscopic examination, basic audiological assessment and transient otoacoustic emission testing (TOAE). Four patients had a conductive hearing loss and five had a bilateral moderately severe high frequency sensory neural hearing loss. TOAE testing was carried out for the rest whose ears displayed normal hearing. No response (fail) was obtained in 8% of them but in none of the controls and a partial pass response in 38% versus 10% of controls (P < 0.001). Cochlear dysfunction was significant only at low frequency levels. The mean overall echo-level and reproducibility were significantly lower in patients than in controls. The same holds true for the subgroup of patients on haemodialysis but not for those on conservative treatment. The overall echo-levels did not correlate with serum urea, creatinine, sodium or potassium.

Intravitreal bevacizumab did not appear to be toxic to the retina or the optic nerve at a concentration of 1.25 mg.

Streptokinase-plasmin doses up to 3 AU were found to be safe when injected into rabbit eyes followed by vitrectomy.