Automated Quantitative Assessment of Retinal Fluid Volumes as Important Biomarkers in Neovascular Age-Related Macular Degeneration.

PURPOSE: To evaluate retinal fluid volume data extracted from optical coherence tomography (OCT) scans by artificial intelligence algorithms in the treatment of neovascular age-related macular degeneration (NV-AMD). DESIGN: Perspective. METHODS: A review was performed of retinal image repository datasets from diverse clinical settings. SETTINGS: Clinical trial (HARBOR) and trial follow-on (Age-Related Eye Disease Study 2 10-year Follow-On); real-world (Belfast and Tel-Aviv tertiary centers). PATIENTS: 24,362 scans of 1,095 eyes (HARBOR); 4,673 of 880 (Belfast); 1,470 of 132 (Tel-Aviv); 511 of 511 (Age-Related Eye Disease Study 2 10-year Follow-On). ObservationProcedures: Vienna Fluid Monitor or Notal OCT Analyzer applied to macular cube scans. OutcomeMeasures: Intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED) volumes. RESULTS: The fluid volumes measured in neovascular AMD were expressed efficiently in nanoliters. Large ranges that differed by population were observed at the treatment-naïve stage: 0-3,435 nL (IRF), 0-5,018 nL (SRF), and 0-10,022 nL (PED). Mean volumes decreased rapidly and consistently with anti-vascular endothelial growth factor therapy. During maintenance therapy, mean IRF volumes were highest in Tel-Aviv (100 nL), lower in Belfast and HARBOR-Pro Re Nata, and lowest in HARBOR-monthly (21 nL). Mean SRF volumes were low in all: 30 nL (HARBOR-monthly) and 48-49 nL (others). CONCLUSIONS: Quantitative measures of IRF, SRF, and PED are important biomarkers in NV-AMD. Accurate volumes can be extracted efficiently from OCT scans by artificial intelligence algorithms to guide the treatment of exudative macular diseases. Automated fluid monitoring identifies fluid characteristics in different NV-AMD populations at baseline and during follow-up. For consistency between studies, we propose the nanoliter as a convenient unit. We explore the advantages of using these quantitative metrics in clinical practice and research.

Cost-effectiveness of diabetic retinopathy screening programs using telemedicine: a systematic review.

BACKGROUND: Diabetic retinopathy (DR) is a significant global public health and economic burden. DR accounts for approximately 15-17% of all cases of total blindness in the USA and Europe. Telemedicine is a new intervention for DR screening, however, there is not enough evidence to support its cost-effectiveness. The aim of this study is to review the most recent published literature on economic evaluations of telemedicine in DR screening and summarize the evidence on the cost-effectiveness of this technology. METHODS: A systematic search of PubMed, Embase and Google Scholar for relevant articles published between January 2010 and January 2020. Studies were included if they met the following criteria: (1) recruited subjects with either type 1, type 2 diabetes (2) evaluated telemedicine technology (3) patients underwent primary screening for DR (4) compared a telemedicine-based intervention with standard care (5) performed an economic evaluation or provided sufficient data for evaluating the cost-effectiveness of the technology used. RESULTS: Of 2238 articles screened, seven studies were included. Four of the studies were conducted in developed countries: The United States, Singapore and two studies in Canada. Three studies were conducted in developing countries: India, Brazil and South Africa. The patient populations in all studies were diabetic patients over the age of 18, previously not screened for DR. All seven studies used a telemedicine program which included capturing a retinal image and subsequently transmitting it to an ocular imaging center to assess the severity of DR. All studies compared telemedicine to a standard screening method for DR, including the option of no screening as standard of care. Although telemedicine requires initial and maintenance costs, it has the potential to provide significant cost savings by increasing patients' working ability, increasing independent living ability, increasing quality of life and reducing travel costs. CONCLUSIONS: Diabetic retinopathy telemedicine technology has the potential to provide significant cost savings, especially in low-income populations and rural patients with high transportation costs.

Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective.

PURPOSE: This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars. MATERIALS AND METHODS: Review of the current literature. RESULTS: Biosimilars are well regulated with the majority of regulators having enforced the guidelines for the development and approval, and new biosimilar drugs are appearing on the horizon to provide a therapeutic option to a wider population base because of its cost-effectiveness and proven safety. Due to their extensive analytical data, clinical data and pharmacovigilance studies, their development should not be considered similar to generic drugs. CONCLUSION: This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective.

The rate of myocardial infarction events among patients with age-related macular degeneration: a population-based study.

PURPOSE: To examine the association between age-related macular degeneration (AMD) and the risk of myocardial infarctions (MIs) in a large health maintenance organization. DESIGN: A retrospective cohort study carried out at Maccabi Healthcare Services (MHS). PARTICIPANTS: A total of 6,546 patients aged ≥65 years who were diagnosed with AMD between April 18 1996 and June 6 2008, and 61,672 non-AMD patients frequency-matched for age and gender. METHODS: Participants were retrospectively followed to the day of leaving the MHS, to undergoing an MI, or to closure of the study on July 1 2008, whichever came earlier. The relative risk of MI associated with AMD was estimated using the Cox proportional hazard model. MAIN OUTCOME MEASURES: Incident myocardial infarction events. RESULTS: During the study period, there were 159 (5.1 per 1,000 person years [PY]) and 2,997 (4.2 per 1,000 PY) MIs respectively in the AMD and non-AMD patient groups. The age- and gender-adjusted hazard ratio (HR) of MI among AMD patients was 1.01 (95%CI: 0.85-1.20). Baseline medical characteristics associated with increased risk of mortality included diabetes mellitus, hypertension, older age, and male gender. The fully adjusted HR associated with AMD was 1.03 (95%CI: 0.87-1.22). CONCLUSION: Despite the shared risk factors associated with AMD and MIs, we found no increased risk of MI in AMD patients.

[Lucentis versus Avastin--is there a light at the end of the tunnel for age-related macular degeneration patients?].

Age-related macular degeneration is the leading cause of blindness and visual impairment in the developed world. The recently introduced anti-vascular endothelial growth factor (VEGF) intravitreal injections of Ranibizumab (Lucentis) and Bevacizumab (Avastin) generated a heated academic argument: on the one hand Lucentis is the only drug that was proven effective and relatively safe in large prospective double-blinded studies, albeit this drug is expensive and might cost up to $1000 per single injection. On the other hand, Avastin is widely used worldwide as a low cost alternative for Lucentis, with an estimated cost of about $120 per injection, although its efficacy and side effects were investigated only in smaller retrospective studies. The ophthalmic community still lacks definite information regarding which is the preferred drug, and awaits the results of a large prospective study comparing the two drugs.