A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

PURPOSE: The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. METHODS: The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. RESULTS: Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. CONCLUSION: This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified.

Venous stasis retinopathy in symptomatic carotid artery occlusion: prevalence, cause, and outcome.

BACKGROUND AND PURPOSE: Chronic ocular ischemia is a rare form of ischemia of the eye in patients with carotid artery occlusion (CAO). The early and often asymptomatic stage of chronic ocular ischemia is referred to as venous stasis retinopathy (VSR). The aim of this study was to gain insight into the prevalence, cause, and outcome of VSR in patients with symptomatic CAO. METHODS: In 110 patients with symptomatic CAO, we prospectively investigated the frequency of VSR, the association between the presence of VSR and impaired cerebral blood flow, and the proportion of patients who developed clinically manifest chronic ocular ischemia with ischemia of the anterior eye segment or blindness. RESULTS: At study entry, VSR was found in 32 patients (29%; 95% CI, 21 to 38), particularly in those with symptoms classically associated with a hemodynamic cause, such as limb shaking (relative risk, 2.4; 95% CI, 1.0 to 5.9). Patients with VSR had lower pulsatility indexes in the ophthalmic artery in case of reversed flow, lower cerebral CO2 reactivity, and lower cerebropetal blood flow than patients without VSR. On follow-up (mean, 29 months), clinically manifest chronic ocular ischemia developed in 4 patients (annual rate, 1.5%; 95% CI, 0.4 to 3.8); it tended to occur more often in patients in whom VSR was present at study entry (relative risk, 7.3; 95% CI, 0.8 to 68). CONCLUSIONS: One third of patients with symptomatic CAO has VSR on ophthalmoscopy. VSR is associated with an impaired flow state of the brain. Development of clinically manifest chronic ocular ischemia is rare.