The SECURE study:long-term safety of Ranibizumab 0.5 mg in neovascular age-related macular degeneration

Objective - To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD). Design - Twenty-four–month, open-label, multicenter, phase IV extension study. Participants - Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study. Methods - Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion). Main Outcome Measures - Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections. Results - Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. Conclusions - The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.

Changing employment relation systems in Japan:cases of the Mitsubishi Chemical Group and the Federation of Shinkin Banks

Over the past decade or so a number of changes have been observed in traditional Japanese employment relations (ERs) systems such as an increase in non-regular workers, a move towards performance-based systems and a continuous decline in union membership. There is a large body of Anglo-Saxon and Japanese literature providing evidence that national factors such as national institutions, national culture, and the business and economic environment have significantly influenced what were hitherto three ‘sacred’ aspects of Japanese ERs systems (ERSs). However, no research has been undertaken until now at the firm level regarding the extent to which changes in national factors influence ERSs across firms. This article develops a model to examine the impact of national factors on ER systems; and analyses the impact of national factors at the firm level ER systems. Based on information collected from two different groups of companies, namely Mitsubishi Chemical Group (MCG) and Federation of Shinkin Bank (FSB) the research finds that except for a few similarities, the impact of national factors is different on Japanese ER systems at the firm level. This indicates that the impact of national factors varies in the implementation of employment relations factors. In the case of MCG, national culture has less to do with seniority-based system. Study also reveals that the national culture factors have also less influence on an enterprise-based system in the case of FSB. This analysis is useful for domestic and international organizations as it helps to better understand the role of national factors in determining Japanese ERSs.

Secure key distribution over a 500 km long link using a Raman ultra-long fiber laser

In traditional communication systems the transmission medium is considered as a given characteristic of the channel, which does not depend on the properties of the transmitter and the receiver. Recent experimental demonstrations of the feasibility of extending the laser cavity over the whole communication link connecting the two parties, forming an ultra-long fiber laser (UFL), have raised groundbreaking possibilities in communication and particularly in secure communications. Here, a 500 km long secure key distribution link based on Raman gain UFL is demonstrated. An error-free distribution of a random key with an average rate of 100 bps between the users is demonstrated and the key is shown to be unrecoverable to an eavesdropper employing either time or frequency domain passive attacks. In traditional communication systems the transmission medium is considered as a given characteristic of the channel, which does not depend on the properties of the transmitter and the receiver. Recent demonstrations of the feasibility of extending the laser cavity over the whole communication link connecting the two parties, forming an ultra-long fiber laser (UFL), have raised groundbreaking possibilities in communication. Here, a 500 km long secure key distribution link based on Raman gain UFL is demonstrated. © 2014 by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Ultralong fiber lasers with coding in free-spectral range for secure key Distribution

We present experimental results on a 50km fiber laser switching among four different values of the free-spectral range for possible applications in secure key-distribution. © 2014 OSA.

Long-range, high bit-rate secure key distribution link utilizing Raman Ultra-long fiber laser (UFL)

The distribution of the secret key is the weakest link of many data encryption systems. Quantum key distribution (QKD) schemes provide attractive solutions [1], however their implementation remains challenging and their range and bit-rate are limited. Moreover, practical QKD systems, employ real-life components and are, therefore, vulnerable to diverse attack schemes [2]. Ultra-Long fiber lasers (UFLs) have been drawing much attention recently because of their fundamentally different properties compared to conventional lasers as well as their unique applications [3]. Here, we demonstrate a 100Bps, practically secure key distribution, over a 500km link, employing Raman gain UFL. Fig. 1(a) depicts a schematic of the UFL system. Each user has an identical set of two wavelength selective mirrors centered at l0 and l 1. In order to exchange a key-bit, each user independently choose one of these mirrors and introduces it as a laser reflector at their end. If both users choose identical mirrors, a clear signal develops and the bits in these cases are discarded. However if they choose complementary mirrors, (1, 0 or 0, 1 states), the UFL remains below lasing threshold and no signal evolves. In these cases, an eavesdropper can only detect noise and is unable to determine the mirror choice of the users, where the choice of mirrors represent a single key bit (e.g. Alice's choice of mirror is the key-bit). These bits are kept and added to the key. The absence of signal in the secure states faxilitates fast measurements to distinguish between the non-secure and the secure states and to determine the key-bit in the later case, Sequentially reapeating the single bit exchange protocol generate the entire keys of any desirable length. © 2013 IEEE.