Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results.

PURPOSE: To compare the efficacy and safety of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd, Basel, Switzerland) versus ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) for neovascular age-related macular degeneration (nAMD) after 2 years when using a treat-and-extend protocol. DESIGN: Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters. PARTICIPANTS: Patients 50 years of age or older with previously untreated nAMD in 1 eye and best-corrected visual acuity 20/25 to 20/320. METHODS: Patients were assigned randomly to receive intravitreal injections with either ranibizumab 0.5 mg or bevacizumab 1.25 mg. Injections were given every 4 weeks until inactive disease was achieved. The treatment interval then was extended by 2 weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was shortened by 2 weeks at a time. MAIN OUTCOME MEASURE: Mean change in visual acuity at 2 years. RESULTS: Of a total of 441 randomized patients, 339 patients (79%) completed the 2-year visit. According to per-protocol analysis at 2 years, bevacizumab was equivalent to ranibizumab, with 7.4 and 6.6 letters gained, respectively (95% confidence interval [CI] of mean difference, -4.1 to 2.5; P = 0.634). Intention-to-treat analysis was concordant, with a gain of 7.8 letters for bevacizumab and 7.5 letters for ranibizumab (95% CI of mean difference, -3.2 to 2.7; P = 0.873). The 2-year results did not show any significant difference in mean central retinal thickness, with a decrease of -113 µm for bevacizumab and -122 µm for ranibizumab (95% CI of mean difference, -32 to 15; P = 0.476). There was a statistically significant difference between the drugs regarding the number of treatments given, with 18.2 injections for bevacizumab and 16.0 injections for ranibizumab (95% CI of mean difference, -3.4 to -1.0; P ≤ 0.001). The number of serious adverse events was similar between the groups over the course of the study. CONCLUSIONS: At 2 years, bevacizumab and ranibizumab had an equivalent effect on visual acuity and reduction of central retinal thickness when administered according to a treat-and-extend protocol for nAMD. There was no significant difference in the number of serious adverse events between the treatment groups.

Prevalence of diabetic retinopathy in Norway: report from a screening study.

PURPOSE: The purpose of the present study was to investigate the prevalence of diabetic retinopathy (DR) in Norway and adherence to the Norwegian Guidelines for screening for diabetic eye disease. METHODS: Two hundred and ninety-nine people with diabetes were randomly recruited from the patient lists of randomly selected general practitioners from three different regions in Norway. Retinopathy was evaluated from retinal photographs after dilation of the pupils using a red-free digital camera and visual acuity was measured using the Snellen chart. The patients were interviewed about their ophthalmological and general diabetes control, duration and type of diabetes and medical treatment. RESULTS: The prevalence of any DR was 28%, 66% for type 1 and 24% for type 2 diabetes. The prevalence of proliferative retinopathy was 38% in type 1 and 1.5% in type 2 diabetes. Two patients (one type 1 and one insulin-treated type 2) were visually impaired (visual acuity 0.3 or worse in the better eye) because of proliferative DR. Twenty-six per cent of the patients had never been to an eye examination, and only 69% attended routine eye examinations. Patients who did not attend regular eye screenings were mostly people with type 2 diabetes. CONCLUSION: The prevalence of DR was higher than previously reported in Norway. Screening for DR did not follow guidelines in a considerable proportion of the patients with type 2 diabetes. There is place for improvement in the implementation of guidelines for screening for DR for people with type 2 diabetes in Norway.