Evaluating the Relationship Between Visual Acuity and Utilities in Patients With Diabetic Macular Edema Enrolled in Intravitreal Aflibercept Studies

PURPOSE. The purpose of this study was to explore the relationship between visual acuity and utility (health-related quality of life) in diabetic macular edema (DME) using intravitreal aflibercept data. METHODS. The relationship between visual acuity in the best-seeing eye (BSE) and worseseeing eye (WSE) and utility was explored using ordinary least squares (OLS) and randomeffects models adjusted for different covariates (age, age2 , sex, body mass index, smoking status, glycated hemoglobin, diabetes severity, comorbidities, and geographic region). Utility was measured using the EuroQoL-five dimensions questionnaire (EQ-5D) and Visual Functioning Questionnaire-Utility Index (VFQ-UI). For each model, coefficients (R2 ) were reported, and WSE/BSE was expressed as the ratio of coefficients (OLS models). Models were independent of treatment effects, and outcomes from all time points (up to week 100) were included where available. RESULTS. Data from 1320 patients with DME were analyzed. In all models, the association between visual acuity (BSE > WSE) was stronger with VFQ-UI– than EQ-5D–derived utilities. The estimated relationship between VFQ-UI and visual acuity in the BSE and WSE was robust, even with an increasing number of covariates. WSE/BSE coefficient ratios were similar across VFQ-UI OLS models (32%) compared with EQ-5D models (41%–48%). Actual (unadjusted) versus predicted data plots also showed a better fit with VFQ-UI– than EQ-5D–derived utilities. CONCLUSIONS. These analyses show that VFQ-UI was more sensitive than EQ-5D–derived utilities for measuring the impact of visual acuity in the BSE and WSE. Visual acuity in the BSE was a major contributor to utility, but WSE is also important though to a lesser degree as shown by the coefficient ratios. These new data will be useful for health technology assessments in DME, where utilities data are lacking. Keywords: diabetic macular edema, intravitreal aflibercept, utilit

Venous reflux in patients with previous deep venous thrombosis: Correlation with ulceration and other symptoms

Purpose: Deep vein thrombosis (DVT) in many cases leads to chronic symptoms in the damaged leg, even though the affected veins have recanalized. The major hemodynamic defect in such recanalized veins is reflux. The incidence and extent of reflux has been studied in patients with proven DVT and correlated with concurrent symptoms. Methods: Two hundred seventeen limbs in 183 patients were examined by duplex scanning from January 1989 to October 1992. All limbs had previous DVT diagnosed by venography. Sites and extent (proximal, distal, or both) of reflux were identified by meticulous duplex scanning of the whole venous system and correlated with presenting symptoms. Results: The patients were classified into nine groups on the basis of the classification of the system involved (superficial, deep, or superficial and deep) and whether the reflux was found proximal or distal to the knee or both. Eighty-one limbs belong to chronic venous insufficiency class 1, 92 belong to class 2, and 38 belong to class 3. Reflux was confined to the deep venous system in 84 limbs (38.7%), to the superficial system in 31 (14.3%) limbs, and to both systems in 102 (47%) limbs. It was confined to proximal veins only in 48 (22.1%) limbs, distal only in 56 (25.8%) limbs and throughout the limb in 113 (52.1%) limbs. The incidence of swelling was increased by distal or a combination of proximal and distal reflux regardless of which system was involved. In limbs with superficial venous insufficiency (SVI) or deep venous insufficiency (DVI) only, the incidence of skin changes was not affected by the extent of reflux. However, in limbs with combined SVI and DVI, it was increased in the presence of reflux throughout the limb. Absence of distal reflux was associated with a low incidence of skin changes even in the presence of DVI. Ulceration increased with an increased extent of reflux in the presence of SVI. Absence of superficial reflux was associated with a low incidence, even in the presence of DVI. Conclusions: The data suggest that as far as the skin changes and ulceration are concerned, distal reflux and reflux in the superficial veins are more harmful than reflux confined to the deep veins, even when such reflux extends throughout the deep venous system

Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: Outcomes in the Japanese subgroup of the VIEW 2 study

Background/aims To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial. Methods In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52. Results At week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups. Conclusions IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population. © 2014 by the BMJ Publishing Group Ltd

Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: Outcomes in the Japanese subgroup of the VIEW 2 study

Background/aims To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial. Methods In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52. Results At week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups. Conclusions IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population. © 2014 by the BMJ Publishing Group Ltd

Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: Outcomes in the Japanese subgroup of the VIEW 2 study

Background/aims To evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial. Methods In this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52. Results At week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups. Conclusions IVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population. © 2014 by the BMJ Publishing Group Ltd