Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)

Background: The effectiveness of ranibizumab in the treatment of diabetic macular edema has been proven with large clinical trials. For bevacizumab only two clinical trials have been published and a head-to-head comparison is lacking to date. However, if proved non-inferior to ranibizumab, use of the off-label bevacizumab could reduce costs enormously without a loss in visual acuity. A cost-effectiveness study has been designed to substantiate this hypothesis. Aim: To compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab given as monthly intravitreal injections during 6 months in patients with diabetic macular edema. It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness. Design: This is a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands. Outcomes: The primary outcome measure is the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6. Secondary outcomes are the proportions of patients with a gain or loss of 15 letters or more or a BCVA of 20/40 or more at 6 months, the change in leakage on fluorescein angiography and the change in foveal thickness by optical coherence tomography at 6 months, the number of adverse events in 6 months, and the costs per quality adjusted life-year of the two treatments

Central Serous Chorioretinopathy, Corticosteroids, and Uveitis

Any patient with a diagnosis of central serous chorioretinopathy (CSCR) should be questioned to determine any recent corticosteroid use, as the poor visual outcome may be due to unrecognized corticosteroid use. Atypical forms of CSCR may be misdiagnosed as an inflammatory serous retinal detachment, mainly Vogt-Koyanagi-Harada disease. CSCR that develops in association with preexisting uveitis could be a challenging diagnosis as it might be misinterpreted as a worsening of the primary inflammatory condition. Failure to differentiate CSCR from retinal or choroidal inflammatory diseases may result in inappropriate use of corticosteroids, leading to exacerbation of the condition and permanent visual loss. Discontinuation of corticosteroids should be the first step in the treatment of CSCR associated with corticosteroid therapy, and the use of immunosuppressive or immunomodulatory drugs may be required to control systemic or ocular inflammatory disease. The prognosis is usually favorable, but persistent visual loss may occur

The incidence of rhegmatogenous retinal detachment in the Netherlands: Dutch Rhegmatogenous Retinal Detachment Study Group

Objective: To estimate the incidence and characteristics of rhegmatogenous retinal detachment (RRD) in The Netherlands in 2009. Design: Retrospective, observational case series. Participants: All patients with RRD in the Dutch population in 2009. Methods: By reviewing surgical logs, cases of primary RRD repair in 2009 were identified. Exclusion criteria included RRD before 2009 and exudative, tractional, or traumatic retinal detachments. Patient demographics, date of surgery, and lens status were documented. Incidence of RRD and 95% confidence intervals (CIs) were calculated based on the Poisson distribution. Age distribution, male-to-female ratio, and proportion of RRD patients with prior cataract extraction (CE) were determined. A Student t test was used to examine differences in the incidence of RRD between groups. Main Outcome Measures: Annual RRD incidence in the population and per gender-adjusted age category and proportion of RRD patients with prior CE. Results: The annual RRD incidence was 18.2 per 100 000 people (95% CI, 11.4–18.8), with a peak incidence of 52.5 per 100 000 people (95% CI, 29.4–56.8) between 55 and 59 years of age. The Bilateral RRD rate was 1.67%. Macula-off presentation occurred in 54.5% of all RRD patients. Prior CE was noted in 33.5% of RRD eyes. The male-to-female ratio was 1.3:1, and RRD incidence was statistically significantly more frequent in males (P 0.0001). Conclusions: Rhegmatogenous retinal detachment is predominantly a disease of the population older than 50 years, and males are more susceptible to RRD. The annual RRD incidence is highly dependent on demographic characteristics