Effectiveness of Mp-3 Microperimetric Biofeedback Fixation Training For Low Vision Rehabilitation in Patients Treated With Corticosteroid Ivt in Retinal Vein Occlusions.

Background: The success of fixation training using microperimetric biofeedback (MP-3 MBFT) in the realm of visual rehabilitation for patients with central vision loss caused by macular pathologies is well established. This study aimed to assess the effectiveness and safety of visual rehabilitation with microperimetric biofeedback in consolidating the benefits obtained, with the goal of reducing the need for repeated intravitreal injections (IVT). Specifically, the focus is on the eyes of patients with central vision loss treated with slow-release corticosteroid IVT following retinal venous thrombosis (RVO), aiming to enhance and maintain postoperative efficacy. Methods: This retrospective review involved the examination of 44 eyes affected by macular edema due to RVO associated with central vision loss. Patients were divided into two groups, with only one undergoing ten sessions of 10-minute visual rehabilitation with a microperimeter (MP-3 MBFT) after IVT over a period of 20 weeks. Results: All the treated patients demonstrated good tolerance to the procedure, with no reported complications. A comparison of best-corrected visual acuity (BCVA), retinal sensitivity recorded with a microperimeter, and pre-IVT fixation stability revealed statistically significant improvements at the end of the first month after IVT. However, the treatment group continued to exhibit superior and more enduring results at four months post-IV. Conclusion: The synergistic use of MP-3 MBFT rehabilitation after IVT with slow-release corticosteroids has proven particularly effective in improving BCVA and long-term fixation stability. This led to a significant reduction in the number of required IVTs, with no related adverse events. The authors argue that biofeedback utilization represents a noninvasive therapeutic option devoid of contraindications and easy to implement and that it positively contributes to the overall patient experience regarding quality of life in advanced stages of macular diseases.

Role of inflammation in diabetic macular edema and neovascular age-related macular degeneration.

Diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) are multifactorial disorders that affect the macula and cause significant vision loss. Although inflammation and neoangiogenesis are hallmarks of DME and nAMD, respectively, they share some biochemical mediators. While inflammation is a trigger for the processes that lead to the development of DME, in nAMD inflammation seems to be the consequence of retinal pigment epithelium and Bruch membrane alterations. These pathophysiologic differences may be the key issue that justifies the difference in treatment strategies. Vascular endothelial growth factor inhibitors have changed the treatment of both diseases, however, many patients with DME fail to achieve the established therapeutic goals. From a clinical perspective, targeting inflammatory pathways with intravitreal corticosteroids has been proven to be effective in patients with DME. On the contrary, the clinical relevance of addressing inflammation in patients with nAMD has not been proven yet. We explore the role and implication of inflammation in the development of nAMD and DME and its therapeutical relevance.

Real-World Evidence of the Long-Term Effectiveness of 0.2 µg/Day Fluocinolone Acetonide Implant in Persistent and Recurrent Diabetic Macular Edema - A Single Center Study.

Purpose: To report the long-term functional, anatomical and safety outcomes of 0.2 µg/day fluocinolone acetonide 0.19mg in patients with persistent or recurrent diabetic macular edema (DME). Methods: Retrospective, observational, single-center study of patients with recurrent or persistent DME. All patients received 0.2 µg/day of fluocinolone acetonide 0.19mg, and data were collected at baseline and months 1, 3, 6, 12, 24 and 36 after implantation. Outcomes measured included best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and safety outcomes. Results: A total of 28 eyes from 28 patients were included. The mean age was 66.5 years (95% CI 62.8-70.2) with a mean duration of DME of 8.8 years (95% CI 7.7-10.0). Only two eyes were phakic. Mean follow-up was 25.4 months (95% CI 21.2-29.6). Mean BCVA at baseline was 48.6 ETDRS letters (95% CI 41.3-55.8) and improved as early as month 1 of follow-up with a mean gain in BCVA of 7.8 (95% CI 4.3-11.3) ETDRS letters (p<0.001). Statistically significant improvements in BCVA were also observed at months 6, 12 and 24. At baseline, patients had a mean CMT of 530.5µm (95% CI 463.0-598.0), and a decrease in CMT was observed, starting at the first month of follow-up (mean CMT reduction of -170.5µm, 95% CI -223.8- -117.1; p<0.001). Statistically significant decreases in CMT were also observed at months 6, 12, 24, and 36, with the maximum decrease observed at month 12 (p<0.001). Mean IOP at baseline was 16.4mmHg (95% CI 15.3-17.5) and nine eyes (32.1%) had an IOP ≥21mmHg during follow-up. Conclusion: Our results support the effectiveness and safety profile of fluocinolone acetonide. Although additional long-term real-world evidence is required, fluocinolone acetonide may represent a safe strategy for daily, low-dose, sustained and localized release to the posterior segment of the eye, providing both functional and anatomical benefits in DME.

Intraocular Pressure Changes After Intravitreal Fluocinolone Acetonide Implant: Results from Four European Countries.

INTRODUCTION: The 0.19 mg fluocinolone acetonide (FAc) intravitreal implant delivers a continuous intravitreal corticosteroid dose for the treatment of refractory diabetic macular oedema (DMO). The aim of this study was to assess the impact of an FAc intravitreal implant on intraocular pressure (IOP). METHODS: We retrospectively collected anonymised data on the patients' characteristics, DMO treatment, and IOP and IOP-lowering treatments before and after the FAc intravitreal implant between September 2013 and March 2020 in several European centres. RESULTS: A total of 221 eyes from 179 patients were included. The mean follow-up duration was 13.4 (± 12.5, range 2.4-33.5) months. Overall, 194 eyes (88.2%) had received an intravitreal dexamethasone injection before the FAc intravitreal implant. For 25 eyes (11.3%) there was a history of glaucoma, and 52 eyes (23.5%) had previous IOP-lowering treatment. Mean IOP before injection was 14.7 (3.4) mmHg and increased to 16.9 (3.7) mmHg 12 months after injection (P < 0.0001). During follow-up, 55 eyes (24.9%) required the addition or initiation of topical IOP-lowering medication, only one patient (0.5%) had laser trabeculoplasty and one patient (0.5%) a minimally invasive glaucoma surgery, and no patient required incisional IOP-lowering surgery. CONCLUSION: The FAc intravitreal implant led to substantial IOP elevation. This elevation was monitored most of the time with addition or initiation of topical IOP-lowering medication.

Dril Influences Short-term Visual Outcome after Intravitreal Corticosteroid Injection for Refractory Diabetic Macular Edema.

Purpose: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) are considered the gold standard for diabetic macular edema (DME). Despite adequate anti-VEGF treatments, many patients present persistent DME. The aim of this study is to identify systemic, ocular and anatomical characteristics influencing functional and anatomical outcomes in refractory DME patients treated with IVI of corticosteroid.Materials and Methods: Retrospective multicenter hospital-based cohort study including type 2 diabetic adult patients with refractory DME that switched from intravitreal anti-VEGF to intravitreal corticosteroid between January 2017 and September 2018. Sociodemographic, clinical data, DME and treatment characteristics were collected at baseline (visit before switch), as well as spectral domain OCT features.Results: A total of 101 eyes were included. The median number of anti-VEGF injections before switch was 5.0 (min-max: 4.0-9.0) and the median anti-VEGF treatment duration before switch was 33.2 (min-max: 19.5-50.3) months. More than half of the patients (56; 54.9%) were diagnosed with diffuse DME. At baseline, 80 (88%) patients had cystoid DME, 55 (62.5%) patients had disorganization of retinal inner layers (DRIL) and 16 (17.6%) had subretinal fluid. Dexamethasone was the corticosteroid more commonly used (71.4%), followed by triamcinolone (24.4%) and fluocinolone (4.2%). Regarding best corrected visual acuity (BCVA), post-switch results showed no statistically significant improvement at three-month follow-up (p = .048/0.096), but the mean central macular thickness (CMT) decreased significantly from 486.3 (SD = 159) µm to 369.3 (SD = 129) µm at three-month follow-up (p < .001). DRIL was the tomographic characteristic able to influence significantly both CMT and BCVA final results (p = .02 and 0.012, respectively).Conclusions: Subfoveal DRIL on structural OCT was the DME factor influencing significantly clinical and imaging outcomes in refractory DME patients treated with intravitreal corticosteroid. Portuguese care trend towards DME shows preference for the use of dexamethasone implant after therapeutic failure with ranibizumab or bevacizumab injection.

Current Best Clinical Practices-Management of Retinal Vein Occlusion.

Retinal vein occlusion (RVO) is the second most common cause of vision loss from retinal vascular diseases in adults in the United States. Visual loss arises as a result of a host of factors, including macular ischemia and macular edema. Primary antivascular endothelial growth factor therapy is the current standard of care, with level I evidence demonstrating sustained visual gains up to 2 years after treatment in both branch and central RVO. Prompt antivascular endothelial growth factor therapy is important because delays in treatment yield lesser visual gains. Steroid therapy also improves visual outcomes in RVO but with higher rates of adverse effects, including cataract formation and ocular hypertension. Although the treatment burden can be high, these drugs have collectively revolutionized treatment outcomes in this disease state, providing improved visual outcomes over previous laser therapies.

The USER Study: A Chart Review of Patients Receiving a 0.2 µg/day Fluocinolone Acetonide Implant for Diabetic Macular Edema.

INTRODUCTION: To determine anatomical, functional, and intraocular pressure (IOP) responses to diabetic macular edema (DME) treatments pre- and post-0.2 µg/day fluocinolone acetonide (FAc) implant administration compared with baseline and the preceding 3 years. METHODS: This was a retrospective, chart review, cohort study in four U.S. centers. Patients received the 0.2 µg/day FAc implant for the treatment of DME in at least one eye before January 1, 2016. DME treatments administered up to 36 months pre-FAc implant and up to 24 months post-FAc implant were recorded, and treatment frequency was calculated. Visual acuity (VA) was assessed using a Snellen eye chart and converted to early treatment diabetic retinopathy study (ETDRS) letters, and central subfield thickness (CST) was measured using optical coherence tomography (OCT). Treatment frequency, mean VA, mean CST, percentage of patients with CST of ≤ 300 µm, mean IOP, IOP events, and IOP treatments pre- and post-FAc implant administration were measured. Positive and negative predictive values for the IOP response to prior steroid therapy were also determined. RESULTS: In total, 160 eyes of 130 patients were studied. VA was maintained at pre-FAc levels from baseline to month 24, despite a significant reduction in treatment frequency from one treatment every 2.9 months pre-FAc implant to one treatment every 14.3 months post-FAc implant. Patients with better baseline VA required fewer DME treatments post-FAc than did patients with worse baseline VA. The majority of patients did not require additional DME treatment during the post-FAc follow-up period. A significant reduction in CST and an increase in the percentage of patients with CST of ≤ 300 µm were seen up to month 21 post-FAc implant. Pre-FAc implant IOP was maintained during the post-FAc implant period; increased IOP with prior steroid therapy was found to be highly predictive of increased IOP post-FAc implant. CONCLUSION: The results of this study confirm the positive safety and efficacy profile of the FAc implant and demonstrate for the first time the effectiveness of the U.S. label indication of FAc in reducing the incidence of post-treatment pressure elevation. The FAc implant significantly reduced treatment burden in the overall population without significantly increasing the risk of steroid-induced pressure elevation. FUNDING: Alimera Sciences.

Intravitreal sustained-release dexamethasone implant for the treatment of persistent cystoid macular edema in ocular syphilis.

With a resurgence of syphilis with human immunodeficiency virus (HIV) infection in last few years, various ocular manifestations of syphilis have been described in literature. This case report described an HIV-positive patient on anti-retroviral therapy who was diagnosed and treated for posterior uveitis secondary to ocular syphilis in the recent past presented to our clinic with cystoid macular edema (CME). CME, which did not respond to periocular corticosteroid, resolved with intravitreal sustained release dexamethasone implant. There was a recurrence CME 9 months later and repeat injection of intravitreal implant showed complete resolution. A long-term follow-up did not reveal reactivation of the infection with intravitreal corticosteroid. Intravitreal sustained release dexamethasone implant can be an effective treatment for refractory CME in patients with regressed syphilitic uveitis.

Preliminary evaluation of YUTIQ™ (fluocinolone acetonide intravitreal implant 0.18 mg) in posterior uveitis.

Uveitis is a major cause of ocular morbidity, potentially leading to significant visual impairment. The recent adoption of alternative drug delivery options has led to the development of new sustained-delivery corticosteroid systems, able to manage successfully chronic noninfectious posterior uveitis. The treatment goal is to target the site of inflammation with low dose of corticosteroids, delivered over an extended period of time, to minimize the cumulative damage resulting from repeated recurrences, reducing both injections frequency and ocular side effects. This article will review the pharmacology and preliminary clinical data of the 0.18 mg fluocinolone acetonide intravitreal implant (YUTIQ™), to show its efficacy and safety in the treatment of noninfectious posterior uveitis.

Corticosteroid Treatment in Diabetic Macular Edema.

Diabetic macular edema is the most common cause of visual impairment in patients with diabetes mellitus. The pathogenesis of macular edema is complex and multifactorial. For many years, laser photocoagulation has been considered the standard therapy for the treatment of diabetic macular edema; however, few patients achieve significant improvements in visual acuity. Today the intravitreal administration of anti-inflammatory or anti-angiogenic agents together with the use of laser photocoagulation represents the standard of care for the treatment of this complication. The intravitreal route of administration minimizes the systemic side effects of corticosteroids. Steroid-related ocular side effects are elevated intraocular pressure and cataract, while injection-related complications include endophthalmitis, vitreous hemorrhage, and retinal detachment. In order to reduce the risks and complications, intravitreal implants have been developed recently to provide sustained release of corticosteroids and reduce repeated injections for the management of diabetic macular edema. In this review, the efficacy, safety, and therapeutic potential of intravitreal corticosteroids in diabetic macular edema are discussed with a review of recent literature.

Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study.

PURPOSE: To evaluate the efficacy and safety of sustained-delivery fluocinolone acetonide (FAc) intravitreal implant for diabetic macular edema (DME). PATIENTS AND METHODS: Prospective study in patients with DME insufficiently responsive to laser and anti-vascular endothelial growth factor (anti-VEGF). Patients with history of rise of intraocular pressure after intravitreal corticosteroids were excluded. RESULTS: The macular edema rapidly decreased both in group 1 (prior laser only; n=7 eyes) and group 2 (prior laser and ≥3 monthly anti-VEGF therapy; n=10 eyes) and central subfield thickness was reduced by -299 µm (P=0.008) and -251 µm (P=0.016) at 12 months, respectively. Mean area under the curve from baseline to last value for pseudophakic eyes was +4.2 letters in group 1 and +9.5 letters in group 2. Overall, the FAc implant was well tolerated. CONCLUSION: This prospective study confirms the efficacy of the FAc implant in DME patients insufficiently responsive to laser and anti-VEGF. Moreover, with a careful patient selection, our safety results would support an earlier use of FAc in the DME treatment pathway.