Fluocinolone acetonide 0.2 µg/day intravitreal implant in non-infectious uveitis affecting the posterior segment: EU expert user panel consensus-based clinical recommendations.

BACKGROUND: Non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) is an inflammatory disease, which can significantly impair visual acuity if not adequately treated. Fluocinolone-acetonide sustained-release-0.2 µg/day intravitreal (FAc) implants are indicated for prevention of relapse in recurrent NIU-PS. The aim here was to provide treating clinicians with some consensus-based-recommendations for the clinical management of patients with NIU-PS with 0.2 µg/day FAc implants. METHODS: A European-clinical-expert-group agreed to develop a consensus report on different issues related to the use of FAc implants in patients with NIU-PS. RESULTS: The Clinical-expert-panel provided specific recommendations focusing on clinical presentation (unilateral/bilateral) of the NIU-PS; systemic involvement of NIU-PS and the lens status. Treatment algorithms were developed; one that refers to the management of patients with NIU-PS in clinical practice and another that establishes the best clinical scenarios for the use of FAc implants, both as monotherapy and as adjuvant therapy. Additionally, the Clinical-expert-panel has provided recommendations about the use of the FAc implants in a clinical-setting. The Clinical-expert-panel also considered the safety profile of FAc implants and their possible implications in the daily practice. CONCLUSIONS: As more clinical experience has been gained using FAc implants, it was necessary to update the clinical recommendations that guide patient management in the clinic. The current consensus document addresses relevant issues related to the use of FAc implants on different types of patients with various etiologies of NIU-PS, and was conducted to standardize approaches to help specialists obtain better clinical outcomes.

Treatment of Non-Infectious Posterior Uveitis with Dexamethasone Intravitreal Implants in a Real-World Setting.

Purpose: The present study aimed to assess the efficacy and safety associated to the treatment of patients with non-infectious posterior uveitis with intravitreal dexamethasone (DEX) implants in a real-world clinical setting. Patients and Methods: This is a retrospective, single center analysis of the data from 29 patients with non-infectious posterior uveitis in whom 38 eyes were treated with dexamethasone intravitreal implants in routine clinical practice between January 2012 and October 2017. The parameters of visual acuity (VA), intraocular pressure (IOP) and central retinal thickness (CRT) were recorded 6 weeks after the first implant was administered, in accordance with the clinical guidelines for the use of these implants, and after a 6-month follow-up period. In addition, the formation of cataracts was evaluated at 12 months. Results: Treatment with the DEX implant caused a significant improvement in the VA from baseline at 6 weeks in eyes treated with 2-6 implants and for eyes without cataracts. A significant decrease in CRT was observed relative to the baseline at 6 weeks for eyes treated with 1 and 2-6 implants, which was maintained at 6 months for those eyes treated with 2-6 implants. This significant improvement in CRT at 6 weeks and 6 months was evident in eyes with and without cataracts. During the study period, the IOP was found to increase significantly from baseline at 6 weeks in some eyes but this was managed topically, and no surgical intervention was necessary. Conclusion: Intravitreal DEX implants represent an effective and safe therapy for the treatment of non-infectious uveitis in routine clinical practice, producing favorable visual and anatomical outcomes after the administration of just 2-6 DEX implants.

Treatment choices for diabetic macular oedema: a guideline for when to consider an intravitreal corticosteroid, including adaptations for the COVID-19 era.

First-line treatment of centrally involved diabetic macular oedema (CI-DMO) is often with an anti-vascular endothelial growth factor (anti-VEGF) agent. Although this can provide efficacy in the majority of eyes, a sizeable proportion do not respond sufficiently and many continue to receive anti-VEGF therapy after it may be optimal. This imposes a treatment burden on both patients and clinicians and, most importantly of all, can be sight threatening. Changing treatment to an intravitreal corticosteroid implant at the appropriate time may help optimise patient outcomes and reduce injection frequency, thereby reducing treatment burden. Eight retina specialists convened to discuss how to ensure eyes with CI-DMO receiving intravitreal anti-VEGF therapy are evaluated for a potential change to intravitreal corticosteroid therapy at the most effective time in their treatment journey. They concluded that clear criteria on when to consider changing treatment would be helpful and so developed a consensus guideline covering key decision points such as when and how to assess response to anti-VEGF therapy, when to consider a change to corticosteroid therapy and when and how to assess the response to corticosteroid therapy. The guideline was developed before the COVID-19 pandemic but, with the additional challenges arising from this including even greater pressure on clinic capacity, it is more important than ever to reconsider current working practices and adopt changes to improve patient care while also easing pressure on clinic capacity, reducing hospital visits and maintaining patient safety. This publication therefore also includes suggestions for adapting the guidelines in the COVID-19 era.

Recommendations by a UK expert panel on an aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration.

OBJECTIVES: This report aims to provide clear recommendations and practical guidance from a panel of UK retinal experts on an aflibercept treat-and-extend (T&E) pathway that can be implemented in clinical practice. These recommendations may help service providers across the NHS intending to implement a T&E approach, with the aim of effectively addressing the capacity and resource issues putting strain on UK neovascular age-related macular degeneration (nAMD) services while promoting patients' best interests throughout. METHODS: Two structured roundtable meetings of retinal specialists were held in London, UK on 7 December 2018 and 1 March 2019. These meetings were organised and funded by Bayer. RESULTS: The panel provided recommendations for an aflibercept T&E pathway and developed specific criteria based on visual acuity, retinal morphology and optical coherence tomography imaging to guide reduction, maintenance and extension of injection intervals. They also discussed the extension of treatment intervals by 2- or 4-week adjustments to a maximum treatment interval of 16 weeks, the management of retinal fluid and the stopping of treatment. CONCLUSIONS: The long-term benefits of implementing a T&E pathway may include superior visual outcomes compared with a pro re nata (PRN; as needed) protocol, and a lower treatment burden compared with a fixed protocol, which is likely to improve service capacity. Furthermore, the predictable nature of a T&E approach compared with a PRN service may aid capacity planning for the future nAMD treatment demand.

Action on neovascular age-related macular degeneration (nAMD): recommendations for management and service provision in the UK hospital eye service.

This report by a group of UK retina specialists and health professionals considers best practice recommendations for the management of sight-threatening neovascular age-related macular degeneration (nAMD), based on collective experience and expertise in routine clinical practice. The authors provide an update for ophthalmologists, allied healthcare professionals and commissioners on practice principles for optimal patient care and service provision standards. Refinement of care pathways for nAMD has improved access to intravitreal anti-vascular endothelial growth factor therapy but there are still variations in care and reported outcomes between clinic centres. Innovative organisational models of service provision allow providers to better match capacity with increasing demand. The authors review the recent NICE guideline for diagnosis and management of AMD, considerations for switching therapies and stopping treatment and need for regular monitoring of non-affected fellow eyes in patients with unilateral nAMD. Actions for delivery of high-quality care and to improve long-term patient outcomes are discussed. Local pathways need to detail nAMD target time to treat, maintenance of review intervals to ensure proactive treatment regimens are delivered on time and appropriate discharge for patients deemed low risk or no longer benefiting from treatment. Actual visual acuity outcomes achieved and maintenance of the level of vision when disease stability is achieved are considered good measures for judging the quality of care in the treatment of patients with nAMD. Robust community referral pathways must be in place for suspected reactivation of choroidal neovascularisation and rapid referral for second eye involvement. Practical considerations for intravitreal injection therapy are outlined.

Aflibercept treatment for neovascular AMD beyond the first year: consensus recommendations by a UK expert roundtable panel, 2017 update.

National recommendations on continued administration of aflibercept solution for injection after the first year of treatment for neovascular age-related macular degeneration (nAMD) have been developed by an expert panel of UK retina specialists, based on clinician experience and treatment outcomes seen in year 2. The 2017 update reiterates that the treatment goal is to maintain or improve the macular structural and functional gains achieved in year 1 while attempting to reduce or minimize the treatment burden, recognizing the need for ongoing treatment. At the end of year 1 (ie, the decision visit at month 11), two treatment options should be considered: do not extend the treatment interval and maintain fixed 8-weekly dosing, or extend the treatment interval using a treat-and-extend regimen up to a maximum 12 weeks. Criteria for considering not extending the treatment interval are persistent macular fluid with stable vision, recurrent fluid, decrease in vision in the presence of fluid, macular hemorrhage, new choroidal neovascularization or any other sign(s) of exudative disease activity considered vision threatening in the opinion of the treating clinician. Treatment extension is recommended for eyes with a dry macula (ie, without macular fluid) and stable vision. Under both options, the treatment interval may be shortened if visual and/or anatomic outcomes deteriorate. Monitoring without treatment may be considered for eyes with a fluid-free macula for a minimum duration of 48 weeks. A patient completing one full year of monitoring without requiring injections may be considered for discharge from clinic. The treatment algorithm incorporates return to fixed 8-weekly dosing for disease reactivation during treatment extension and reinstatement of treatment for disease recurrence following discontinuation or discharge. For bilateral nAMD, either the eye requiring the more intensive treatment or the eye with the better vision, guided by local clinical practice, should determine the retreatment schedule overall.