Purpose: To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME).
Design: Two similarly designed, randomized, phase 3 trials, VISTA(DME) and VIVID(DME).
Participants: Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement.
Methods: Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control.
Main Outcome Measures: The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained ≥15 letters, and proportion of eyes with a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score.
Results: Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost ≥15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a ≥2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control).
Conclusions: In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ophtha.2015.06.017 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Correlation of objective and subjective sleep parameters with fatigue and depression in kidney transplant recipients.
Zhong Nan Da Xue Xue Bao Yi Xue Ban
August 2024
Nursing Department, Third Xiangya Hospital, Central South University, Changsha 410013.
Objectives: Sleep quality in kidney transplant recipients is closely associated with symptoms of fatigue and depression. Although subjective assessment tools like the Pittsburgh Sleep Quality Index and the Richards-Campbell Sleep Questionnaire (RCSQ) are widely used to evaluate sleep quality, there is a lack of studies utilizing polysomnography for objective evaluation. This study aims to investigate the correlation between sleep quality, fatigue, and depression in kidney transplant recipients using both subjective and objective methods, providing scientific evidence for improving their quality of life.
View Article and Find Full Text PDFBackground: Sleep deficiency is associated with an increased risk of Alzheimer's disease (AD), warranting research on underlying mechanisms. This study examined the association of sleep architecture with anatomical features frequently observed in AD: (1) atrophy of cuneus, hippocampus, entorhinal, inferior parietal, parahippocampal, and precuneus regions (henceforth referred to as "AD-vulnerable regions") and (2) the presence of cerebral microbleeds.
Method: In 271 participants of the Atherosclerosis Risk in the Communities Study, we examined the prospective association of baseline sleep architecture with anatomical features of the brain identified on MRI conducted ∼17 years later.
Purpose: To evaluate dynamic changes in ciliary parameters and Implantable Collamer Lens V4C (ICL) (STAAR Surgical) haptic position using mydriatic and miotic agents and their effects on the central and peripheral vault.
Methods: This study involved 80 eyes from 40 consecutive patients (mean age: 28.05 years; range: 19 to 42 years) examined 3 months after ICL implantation.
Purpose: To evaluate the 12-month rotational stability and outcomes of V4c toric Implantable Collamer Lenses (TICLs) (STAAR Surgical) located at two different lens orientations (horizontal or oblique).
Methods: This retrospective study included a total of 403 eyes with TICL implantation, enrolled between January 2021 and December 2022, that were divided into two groups based on the minimum intended angle off the horizontal axis: horizontal with 263 eyes at an angle ±22.5 degrees or less and oblique with 140 eyes at a minimum intended angle of greater than ±22.
Alzheimer's Imaging Consortium.
Alzheimers Dement
December 2024
Yale School of Medicine, New Haven, CT, USA.
Background: Sleep deficiency is associated with an increased risk of Alzheimer's disease (AD), warranting research on underlying mechanisms. This study examined the association of sleep architecture with anatomical features frequently observed in AD: (1) atrophy of cuneus, hippocampus, entorhinal, inferior parietal, parahippocampal, and precuneus regions (henceforth referred to as "AD-vulnerable regions") and (2) the presence of cerebral microbleeds.
Method: In 271 participants of the Atherosclerosis Risk in the Communities Study, we examined the prospective association of baseline sleep architecture with anatomical features of the brain identified on MRI conducted ∼17 years later.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!