Purpose: To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative agerelated macular degeneration (AMD).Methods: Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2-or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96. Results: Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2-and 4-week groups, respectively. From baseline, mean change in BCVA was ? 9.0 and ? 8.4 letters (week 52) and ? 7.6 and ? 6.1 letters (week 96); mean change in central retinal thickness was -134.4 lm and -126.1 lm (week 52) and -130.5 lm and -125.3 lm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports. Conclusions: IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11603511.maintained to week 96. Outcomes were similar between the 2-and 4-week groups. Trial Registration: ClinicalTrials.gov identifier, NCT02305238. Key Summary PointsWhy carry out this study?The goal of proactive flexible treat-andextend (T&E) regimens is to reduce the treatment burden associated with antivascular endothelial growth factor (VEGF) therapy, while maintaining a patient's visual acuity gains.The aim of this study was to evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) T&E dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).What was learned from the study?IVT-AFL administered using either 2-or 4-week adjustment T&E regimens in treatment-naïve patients with exudative AMD improved functional (best-corrected visual acuity ? 9.0 and ? 8.4 letters) and anatomic outcomes (central retinal thickness -134.4 and -126.1 lm) at 52 weeks; functional and anatomic outcomes were maintained over 96 weeks.A large proportion of patients (35.1% and 40.5%) had an intended injection interval of 16 weeks at week 52.The incidence of treatment-emergent adverse events was consistent with the known safety profile of IVT-AFL.IVT-AFL T&E regimens were efficacious and safe over 96 weeks of treatment using either 2-or 4-week adjustments.
Purpose There is an urgent need to address how to best provide ophthalmic care for patients with retinal disease receiving intravitreal injections with anti-vascular endothelial growth factor agents during the ongoing global COVID-19 pandemic. This article provides guidance for ophthalmologists on how to deliver the best possible care for patients while minimizing the risk of infection. Methods The Vision Academy's Steering Committee of international retinal disease experts convened to discuss key considerations for managing patients with retinal disease during the COVID-19 pandemic. After reviewing the existing literature on the issue, members put forward recommendations that were systematically refined and voted on to develop this guidance. Results The considerations focus on the implementation of steps to minimize the exposure of patients and healthcare staff to COVID-19. These include the use of personal protective equipment, adherence to scrupulous hygiene and disinfection protocols, pre-screening to identify symptomatic patients, and reducing the number of people in waiting rooms. Other important measures include triaging of patients to identify those at the greatest risk of irreversible vision loss and prioritization of treatment visits over monitoring visits where possible. In order to limit patient exposure, ophthalmologists should refrain from using treatment regimens that require frequent monitoring. Conclusion Management of patients with retinal disease receiving intravitreal injections during the COVID-19 pandemic will require adjustment to regular clinical practice to minimize the risk of exposure of patients and healthcare staff, and to prioritize those with the greatest medical need. The safety of patients and healthcare staff should be of paramount importance in all decision-making.
Purpose-To determine the frequency of occurrence of limited clinical features which distinguish patients with Vogt-Koyanagi-Harada (VKH) disease from those with non-VKH uveitis. Design-Comparative case series. Participants-1147 total patients.Methods-All patients with bilateral ocular inflammatory disease presenting to any of ten uveitis centers in the three month period between 2006-January-01 and 2006-March-31 (inclusive) were asked to participate. The clinical and historical features of disease were obtained from the participants via direct interview and chart review. Patients were stratified based on whether they were diagnosed with VKH disease or non-VKH uveitis for statistical analysis. Main Outcome Measures-Presence or absence of various clinical features in the two populations.Results-Of 1147 patients, 180 were diagnosed with VKH disease and 967 with non-VKH uveitis. Hispanics and Asians were more likely to be diagnosed with VKH than non-VKH disease compared Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author ManuscriptOphthalmology. Author manuscript; available in PMC 2011 March 1. Conclusions-Numerous clinical findings have been described in the past as important in the diagnosis of VKH. The current study reveals that of these, two are highly specific to this entity in an ethnically and geographically diverse group of patients with non-traumatic bilateral uveitis. These clinical findings are 1. exudative retinal detachment during acute disease and 2. sunset glow fundus during the chronic phase of the disease.Vogt-Koyanagi-Harada disease (VKH) is a visually disabling bilateral intraocular inflammation usually associated with extraocular manifestations such as meningismus, vitiligo, poliosis, and dysacusis. 1-3 The extraocular manifestations typically appear in different phases of the disease and may vary in different ethnic groups.1 , 4 -6 For example, cutaneous manifestations are typically absent during the acute phase and appear later in the disease course, while the neurologic and auditory manifestations generally precede ocular manifestations. The absence of concurrent extraocular manifestations may have significant implications for both clinical practice and the conduct of clinical studies, as follows. In the area of clinical practice, variation in manifestations and their timing may cause a delay in establishing the correct diagnosis and thus a delay in the initiation of appropriate treatment. This may result in the disease entering the chronic/recurrent phase and in the subsequent development of complications such as glaucoma, ...
Enhanced depth imaging-optical coherence tomography revealed decreasing choroidal thickness with high-dose corticosteroid treatment in our patients. Choroidal thickness as measured by EDI-OCT may serve as a marker for degree of choroidal inflammation in acute VKH disease.
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