Explore the vast range of titles available.

An artificial intelligence (AI) using a deep-learning approach can classify retinal images from optical coherence tomography for early diagnosis of retinal diseases and has the potential to be used in other image-based medical diagnoses.

A trial of three drugs — bevacizumab, ranibizumab, and aflibercept — for the treatment of diabetic macular edema showed that each drug improved visual acuity, but aflibercept outperformed the other two drugs for eyes with a baseline visual acuity of 20/50 or worse. Diabetic macular edema, a manifestation of diabetic retinopathy that impairs central vision, affects approximately 750,000 people in the United States and is a leading cause of vision loss. 1 The costs associated with visual disability and treatment of diabetic macular edema are high. 2 The increasing prevalence of diabetes worldwide highlights the importance of diabetic macular edema as a global health issue. 3 Vascular endothelial growth factor (VEGF) is an important mediator of abnormal vascular permeability in diabetic macular edema. 4 , 5 Intravitreous injections of anti-VEGF agents have been shown to be superior to laser photocoagulation of the macula, the standard treatment for diabetic . . .

Objective To assess ‘time in range’ as a novel measure of treatment response in diabetic macular oedema (DMO). Methods This post hoc analysis of the Protocol T randomised clinical trial included 660 individuals with centre-involved DMO and best-corrected visual acuity (BCVA) letter score ≤78–≥24 (approximate Snellen equivalent 20/32–20/320). Study participants received intravitreal aflibercept 2.0 mg, repackaged (compounded) bevacizumab 1.25 mg, or ranibizumab 0.3 mg given up to every 4 weeks using defined retreatment criteria. Mean time in range was calculated using a BCVA letter score threshold of ≥69 (20/40 or better; minimum driving requirement in many regions), with sensitivity analyses using BCVA thresholds from 100 to 0 (20/10 to 20/800) in 1-letter increments. Results Time in range was defined as either the absolute or relative duration above a predefined BCVA threshold, measured in weeks or as a percentage of time, respectively. Using a BCVA letter score threshold of ≥69 (20/40 or better), the least squares mean time in range (adjusted for baseline BCVA) in Year 1 was 41.2 weeks with intravitreal aflibercept, 4.0 weeks longer (95% CI: 1.7, 6.3; p  = 0.002) than bevacizumab and 3.6 weeks longer (1.3, 5.9; p  = 0.004) than ranibizumab. Overall, mean time in range was numerically longer for intravitreal aflibercept for all BCVA letter score thresholds between 92 and 30 (20/20 to 20/250). In the Day 365–728 analysis, time in range was 3.9 (1.3, 6.5) and 2.4 (0.0, 4.9) weeks longer with intravitreal aflibercept vs bevacizumab and vs ranibizumab ( p  = 0.011 and 0.106), respectively. Conclusion BCVA time in range may represent another way to describe visual outcomes and potential impact on vision-related functions over time for patients with DMO and provide a better understanding, for physicians and patients, of the consistency of treatment efficacy.

Abstract Purpose Assess correlation between change in central subfield thickness (CST) and change in best-corrected visual acuity (BCVA) in eyes with macular edema due to retinal vein occlusion (RVO) that received intravitreal aflibercept injections (IAI).MethodsPost hoc analysis of COPERNICUS and GALILEO trials for CRVO and VIBRANT trial for BRVO with relationships determined using Pearson correlation coefficient.ResultsIn COPERNICUS, correlations (r) between change in CST and change in BCVA from baseline at weeks 12, 24, 52, and 100 were −0.36 (95% CI: −0.52, −0.18; P < 0.001), −0.38 (95% CI: −0.53, −0.20; P < 0.001), −0.44 (95% CI: −0.58, −0.27; P < 0.001), and −0.41 (95% CI: −0.56, −0.23; P < 0.001), respectively. CST changes accounted for only 21% of the variance in BCVA changes; every 100-µm decrease in CST was associated with a 2.1-letter increase in BCVA (P = 0.003). Similar findings were noted for GALILEO (r, −0.45 to −0.23) and VIBRANT (r, −0.36 to −0.32) trials.ConclusionIn eyes treated with IAI for macular edema due to RVO, correlation between change in CST and change in BCVA was weak to moderate. While change in CST may be helpful in determining the need for anti-VEGF therapy, these findings do not support using changes in CST as a surrogate for changes in visual acuity outcomes.

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).Methods Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.

Background The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. However, important limitations which may affect the interpretation of clinical trial results have been previously identified, such as concerns with reliability and validity. The purpose of this study was to evaluate the National Eye Institute Visual Functioning Questionnaire (NEI VFQ­25) and make recommendations for a revised scoring structure, with a view to improving its psychometric performance and interpretability. Methods Rasch Measurement Theory analyses were conducted in two stages using pooled baseline NEI VFQ­25 data for 2487 participants with retinal diseases enrolled in six clinical trials. In stage 1, we examined: scale-to-sample targeting; thresholds for item response options; item fit statistics; stability; local dependence; and reliability. In stage 2, a post-hoc revision of the scoring structure (VFQ-28R) was created and psychometrically re-evaluated. Results In stage 1, we found that the NEI VFQ­25 was mis-targeted to the sample, and had disordered response thresholds (15/25 items) and mis-fitting items (8/25 items). However, items appeared to be stable (differential item functioning for three items), have minimal item dependency (one pair of items) and good reliability (person-separation index, 0.93). In stage 2, the modified Rasch-scored NEI VFQ­28­R was assessed. It comprised two broad domains: Activity Limitation (19 items) and Socio-Emotional Functioning (nine items). The NEI VFQ­28­R demonstrated improved performance with fewer disordered response thresholds (no items), less item misfit (three items) and improved population targeting (reduced ceiling effect) compared with the NEI VFQ­25. Conclusions Compared with the original version, the proposed NEI VFQ­28­R, with Rasch-based scoring and a two-domain structure, appears to offer improved psychometric performance and interpretability of the vision-related quality of life scale for the population analysed.

Proliferative retinopathy develops in a 55-year-old man with type 2 diabetes. Panretinal photocoagulation, which causes reduced production of VEGF by destroying hypoxic retinal cells, is recommended. Diminished peripheral vision and night vision can occur. Foreword This Journal feature begins with a case vignette that includes a therapeutic recommendation. A discussion of the clinical problem and the mechanism of benefit of this form of therapy follows. Major clinical studies, the clinical use of this therapy, and potential adverse effects are reviewed. Relevant formal guidelines, if they exist, are presented. The article ends with the authors' clinical recommendations. Stage A 55-year-old man with a 20-year history of type 2 diabetes mellitus was referred to a retina specialist after noticing a few black floaters in his left eye for the preceding week. His glycated hemoglobin level was 8.2%. He had no history of laser treatment for proliferative diabetic retinopathy in either eye. Ophthalmoscopic examination of the right eye showed venous beading, intraretinal microvascular abnormalities, and no macular edema. Ophthalmoscopic examination of the left eye showed extensive neovascularization of the disk, consisting of new vessels extending beyond the optic disk in all directions (Figure 1A). The retina specialist diagnosed severe . . .

Diabetic retinopathy is a complication of diabetes mellitus that is clinically characterized by changes in retinal microvasculature. Diabetic retinopathy is now better defined as diabetic retinal disease (DRD), as diabetes mellitus affects not only the retinal microvasculature but the whole retina, including neurons and glia. A global concerted effort to study preclinical and clinical signs of DRD and their association with visual acuity and patient-reported vision-related quality of life, and the integration of these features with systemic health and biochemical milieu in people with diabetes mellitus is underway. The Diabetic Retinopathy Clinical Research Retina Network trials and other researchers have provided substantial robust evidence on the current management of vision-threatening diabetic retinopathy that includes proliferative diabetic retinopathy and diabetic macular oedema. Progress is also being made to develop, evaluate and implement cost-effective strategies for personalized screening, treatment and monitoring, incorporating artificial intelligence as clinical decision support tools, where appropriate. In addition, novel therapies and modes of delivery are being evaluated to increase durability of interventions and improve affordability to improve vision-related quality of life and reduce the global burden of blindness owing to DRD.Diabetic retinal disease describes the spectrum of pathophysiological retinal changes due to diabetes mellitus. In this Primer, Sivaprasad et al. review the epidemiology, mechanisms, diagnosis and management of diabetic retinal disease, and highlight patient quality of life and future research areas.

Background Myopia presents a noteworthy global health concern, urging exploration of innovative treatments. The role of intraocular pressure (IOP) in regulating the progression of myopia has been controversial. Methods To investigate the impact of reducing IOP to varying extents on myopia progression, three groups receiving distinct IOP-lowering medications (Brinzolamide, Latanoprost, and a combination of Brinzolamide and Latanoprost) were designed in a form-deprived myopic guinea pig model. Additionally, proteomics analyses were conducted to identify differentially expressed proteins in the sclera. Results Based on 24-h and 4-week IOP monitoring, the group receiving both Brinzolamide and Latanoprost exhibited the greatest magnitude of IOP reduction and the most significant inhibition of axial length (AL) growth. Moreover, the administration of IOP-lowering medications increased choroidal thickness and induced alterations in the structure of scleral collagen fibrils. Notably, scleral proteomics revealed remodeling processes associated with key mechanisms, including proteolysis, fibrinolysis, and metal ion binding. Conclusions Our findings highlight that pressure-dependent scleral remodeling contributes to the deceleration of AL elongation. These results underscore the efficacy of IOP reduction in mitigating the progression of myopia, providing a promising alternative strategy for myopia management.