Intravitreal fluocinolone acetonide 0.19 mg (Iluvien®) for the treatment of uveitic macular edema: 2-year follow-up of 20 patients.

PURPOSE: To evaluate intravitreal 0.19 mg fluocinolone acetonide implant (FAi) (Iluvien®) for the treatment of chronic non-infectious uveitis with associated cystoid macular edema (CME). METHODS: A retrospective review of medical reports from a single Danish tertiary centre including 20 patients (20 eyes), treated with 0.19 mg FAi for non-infectious uveitic CME. The primary endpoints were change in best corrected visual acuity (BCVA) and central retinal thickness (CRT). The secondary endpoints were recurrence rate, change in systemic treatment, and intraocular pressure (IOP). RESULTS: Mean follow-up of the 20 eyes was 2.3 ± 1.1 years. BCVA improved at 6 (p = 0.13), 12 (p = 0.05), 18 (p = 0.03), and 24 months and CRT decreased at 6 (p = 0.004), 12 (p = 0.006), 18, and 24 months after 0.19 mg FAi. Within 18 months after implantation, four of 14 patients (28.6%) relapsed. Three of five patients discontinued systemic corticosteroids within 4 months and one patient continued with reduced dose. Five of 10 patients receiving disease-modifying antirheumatic drugs (DMARDs) at time of implantation discontinued within 1 year. No patients started new systemic treatment. Eight eyes were treated with topical IOP-lowering medication at the time of implantation, of these two later underwent trabeculectomy. There were no complications associated with previous glaucoma surgery. CONCLUSION: This long-term follow-up study showed that intravitreal treatment with 0.19 mg FAi should be considered in the treatment of chronic non-infectious uveitic CME in selected patients. This treatment is safe even in selected glaucoma patients and may offer reduction or cessation of local or systemic anti-inflammatory treatment.

Effect of Extended Release Steroid Implants on the Contralateral Eye.

PURPOSE: To investigate the contralateral effect of extended release steroid implants on cystoid macular edema (CME). METHODS: Retrospective study of patients with bilateral CME receiving intravitreal injections of long-acting intravitreal corticosteroid implants in one eye. Changes in CME and central subfield thickness (CST) in the contralateral eye on optical coherence tomography (OCT) were compared to an untreated control group. The main outcome measures were the change in central subfield thickness (CST) and the change in the macular volume. RESULTS: Thirteen study patients and 14 controls were included in the study. There was no difference in the baseline LogMAR visual acuity (0.32 ± 0.35 vs 0.43 ± 0.26, p = 0.37) or the baseline central subfield thickness (341.4 ± 76.6 vs 296.5 ± 65.0 µm, p = 0.12) between groups. In the treatment group CST remained stable in 92.3% of the patients. Of the controls, CST worsened in 21.4% and remained stable in 78.6%. The mean change in CST (6.3 ± 30.3 vs. 27.5 ± 66.1 µm, p = 0.2) and the mean change in macular volume (0.08 ± 0.34 vs. -0.05 ± 0.21 mm3, P = 0.8) were not statistically different between the treatment group and control group. In the post-hoc analysis restricting the treatment group to patients who had not received intravitreal injections in the study eye within 6 months, CST decrement was not statistically significant (p = 0.11). CONCLUSION: In this study there was no statistically significant effect on CME of contralateral intravitreal corticosteroid implants.

Treatment of radiation-induced maculopathy with fluocinolone acetonide.

PURPOSE: Chronic macular oedema is a well-known presentation of radiation-induced maculopathy (RM) following external beam photon therapy, plaque radiotherapy and proton beam radiotherapy for choroidal tumours. Current therapies vary in respect of efficacy and clinical benefit. The potential of fluocinolone acetonide (FAc) slow-release implants is unknown. We hypothesised that local continuous delivery of low-dose corticosteroids might improve symptoms of RM. METHODS: Five-two male and three female-patients from 37 to 68 years presented with RM following 106Ru-plaque brachytherapy or stereotactic radiation therapy (STx) with photons using a hypofractionated schedule of 5 × 10 Gy. All were treated with triamcinolone injections in first line and proofed to be refractory to steroids. In addition, two patients had received Ozurdex® implants as a second-line treatment, though without any clinical benefit. FAc slow-release implants were injected, and patients were followed up to monitor clinical improvement. RESULTS: All patients responded to therapy by means of a decrease in macular oedema. In four of five (80%) patients, visual acuity improved, and one patient showed stable visual acuity. No toxic effects or complications were observed. CONCLUSION: Slow-release implants of FAc are a promising therapeutic potent steroid treatment option to benefit anatomical structures of the fovea and visual function. Slow-release implants with FAc reduce the frequency of intravitreal injections and the therapeutic burden.

Treating Diabetic Macular Oedema (DMO): real world UK clinical outcomes for the 0.19mg Fluocinolone Acetonide intravitreal implant (Iluvien™) at 2 years.

BACKGROUND: To compare visual function and structural improvements in pseudophakic eyes with diabetic macular oedema (DMO) treated with the 0.19mg Fluocinolone Acetonide (FAc) intravitreal implant (IluvienTM) in a 'real world' setting. METHODS: A single centre retrospective evaluation of patients with DMO unresponsive to conventional treatment treated with the FAc implant according to UK guidelines. Primary efficacy endpoint was best corrected visual acuity (BCVA); secondary endpoints included optical coherence tomography evaluations of the macula (a) central retinal and (b) peak macular thickness collected at annual time points. Primary safety endpoint was new rise in IOP >27mmHg or glaucoma surgery. Patients with <1 year follow-up were excluded. RESULTS: Twenty-nine eyes were included, with mean(SD) follow up of 792(270) days. Improvement in BCVA and reduction in macular oedema was noted at all timepoints. Mean improvement in BCVA from baseline was 6 ETDRS letters at year 1(n=29), 6.5L at year 2(n=22) and 11L at year 3(n=6). Mean central retinal thickness at baseline was 451 microns, 337 microns at year 1, 342 microns at year 2 and 314 microns at year 3. Two eyes required IOP-lowering drops post implant. Supplementary treatment for persistence or recurrence of DMO was necessary in 18 eyes over the total study period of 3 years with mean time to supplementary treatment being 12 months. CONCLUSIONS: Our evaluation of the 0.19mg FAc implant delivered in a real-world setting, provides additional evidence that it is effective and safe in the treatment of patients with DMO, and can provide sustained benefit for patients with previously refractory disease.

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.

Fluocinolone Acetonide Implant for Uveitis: Dissecting Responder and Non-Responder Outcomes at a Tertiary Center.

Macular edema (ME) remains a primary cause of visual deterioration in uveitis. Visual acuity (VA) can often be maintained using corticosteroid depot systems. This study evaluated the efficacy of a fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) in treating non-infectious uveitis using real-world data. This retrospective analysis included 135 eyes subdivided into responders and non-responders. Central retinal thickness (CRT), VA, and intraocular pressure (IOP) were followed over time. A significant decrease in CRT and an increase in VA were observed in all eyes throughout the follow-up period (p < 0.01). An IOP increase (p = 0.028) necessitated treatment in 43% of eyes by Month 6. Non-responders were older (p = 0.004) and had been treated with more dexamethasone (DEX) implants (p = 0.04); 89.3% had a defect in the external limiting membrane (ELM) and inner/outer segment (IS/OS) zone (p < 0.001). Immunomodulatory therapy had no impact on treatment response. Pars plana vitrectomy (PPV) patients had a mean CRT reduction of 47.55 µm and a reduced effect by Month 24 (p = 0.046) versus non-PPV patients. We conclude that the FAc implant achieves long-term control of CRT and improves VA. Increases in IOP were manageable. Eyes with a previous PPV showed milder results. Data showed a correlation between older age, a damaged ELM and IS/OS zone, frequent DEX inserts, and poorer outcome measures.

[Comparison of available clinical and imaging tools to assess good positioning of a fluocinolone acetonide implant (Iluvien®) in the vitreous cavity after injection]. / Comparaison des moyens clinique et d'imagerie disponibles en pratique clinique pour objectiver la présence de l'implant d'acétonide de fluocinolone (Iluvien®) dans la cavité vitréenne après injection.

INTRODUCTION: Sustained-release corticosteroid implants are injected into the vitreous cavity using preloaded pens. The fluocinolone (FAc) implant is approximately half the size of the dexamethasone implant (Dex-I). It is simply introduced in the vitreous base rather than propelled into the vitreous cavity as is Dex-I. Verification of its positioning after injection is thus difficult by indirect ophthalmoscopy. The goal of our study is to compare the performance of available clinical and imaging tools to confirm the presence of the FAc in the vitreous cavity following injection. METHODS: Twelve eyes of 12 consecutive patients were included in a retrospective, single-center, observational study carried out at the Bordeaux University Hospital, France. All patients were injected with the FAc after pupil dilation, and presence of the implant was immediately checked by indirect biomicroscopy, wide-field retinography (Clarus®, Carl-Zeiss-Meditec, Dublin, CA, USA) and ultra-wide-field retinography (California®, Optos, Edinburgh, United-Kingdom). Seven days later, a B-mode ultrasonography (10MHz, AVISO, Quantel-medical, France) and an UBM ultrasonography (50MHz, AVISO, Quantel-medical, France) were performed. RESULTS: Indirect biomicroscopy and wide-field retinography detected 4/12 implants (33.3%). Ultra-wide-field retinophotography detected 6/12 implants (50%). All the implants seen using indirect biomicroscopy and wide-field retinography were also visualized with ultra-wide-field. B-mode ultrasonography showed 5/12 implants (41.6%) and UBM 9/12 implants (75%). Finally, one implant dislocated into the anterior chamber and was seen in the iridocorneal angle on gonioscopy. CONCLUSION: Objective confirmation of the proper positioning of the FAc implant in the vitreous cavity is mandatory. If both indirect ophthalmoscopy and anterior examination fail to detect it, ultra-wide field retinography along with UBM ultrasonography, if necessary, appear to be the two best imaging modalities to use.

Alternative technique for the injection of fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) in case of leakage of its injector.

PURPOSE: To show an alternative surgical technique for the introduction of the intravitreal fluocinolone acetonide (FAc) implant (Iluvien®) into the vitreous cavity using a 23-gauge (G) trocar if it is retained during its implantation in the subconjunctival space. METHODS: We describe the surgical procedure performed to solve the complication: The FAc implant was extracted from the subconjunctival space using flat retinal forceps. A 23-G trocar was inserted 3,5 mm to the limbus. The same flat retinal forceps were used to take the FAc implant and introduce it into the vitreous cavity using a 23-G trocar. RESULTS: The patient's best corrected visual acuity (BCVA) (Snellen) improved from 20/200 to 20/63 and the central macular thickness (CMT) was reduced from 610 microns (µm) to 215 µm after one week of the FAc implantation. He remained stable after 3 months of follow-up, with a BCVA of 20/63 and a CMT of 191 µm. His intraocular pressure (IOP) remained stable and the integrity of the implant was checked by indirect ophthalmoscopy. CONCLUSION: The introduction of the intravitreal FAc implant using a 23-gauge trocar constitutes a valid alternative if it is retained during its implantation in the subconjunctival space.The functionality of the implant remained intact in our patient.

Visual function and retinal morphological changes after single suprachoroidal delivery of fluocinolone acetonide (Iluvien®) implant in eyes with chronic diabetic macular edema.

BACKGROUND: To assess the efficacy and safety of supra-choroidal (SC) Iluvien in the management of chronic diabetic macular edema (DME). METHODS: A retrospective interventional non-comparative consecutive case series including patients with chronic DME who received an SC Iluvien implant. All patients had persistent central macular thickness (CMT) ≥ 300µ after previous treatment with anti-vascular endothelial growth factor (VEGF) agents or laser photocoagulation. The main outcome measures were improvement of best-corrected visual acuity (BCVA), reduction of CMT, and detection of ocular hypertension/glaucoma or cataract formation. Friedman's two-way ANOVA was used to analyze BCVA, intraocular pressure (IOP), and DME across different time points. P-value = 0.05. RESULTS: The study included 12 eyes of 12 patients. Six patients (50%) were males. The median age was 58 years (range 52-76 years). The median duration of DM was 13 years (range 8-20 years). Ten patients (83.3%) were phakic and 2 patients (17%) were pseudophakic. The median pre-operative BCVA was 0.07 (range 0.05-0.8). The median pre-operative CMT was 544µ (range 354-745µ). The median pre-operative IOP was 17 mmHg (range 14-21mmHg). The median follow-up period was 12 months, range (12-42). Post-operatively, the median final BCVA was 0.15 (range 0.03-1), p 0.02, the median CMT was 404µ (range 213-747), p 0.4 and the median IOP was 19.5 mmHg (range 15-22), p 1. Two out of 10 phakic patients (20%) developed nuclear sclerosis grade I by 12 months. Six patients (50%) developed a transient rise in IOP < 10 mmHg from the baseline that resolved within 3 weeks with antiglaucoma drops. CONCLUSION: SC Iluvien is potentially effective in improving visual function, reducing macular edema, and reducing the incidence of steroid-induced cataracts and glaucoma.

Intravitreal fluocinolone acetonide implant for the treatment of persistent post-surgical cystoid macular edema in vitrectomized eyes.

Cystoid macular edema (CME) is the most common cause of decreased visual acuity after both vitrectomy and cataract surgery. Various strategies have been used for its treatment, such as intravitreal corticosteroids. The intravitreal fluocinolone acetonide implant (Iluvien®) is approved for the treatment of persisting diabetic macular edema and for the prevention of recurrence of non-infectious uveitis affecting the posterior segment. There are very few reports about its off-label use for post-surgical CME. We present four clinical cases of post-surgical CME (three following vitrectomy and one following cataract surgery in a vitrectomized eye 2 years ago). All of them had been previously treated with an average of four injections of intravitreal dexamethasone implant (Ozurdex®), with repeated recurrence of CME. After treatment with Iluvien, three cases showed improvement of both visual acuity and macular anatomy, with resolution of the macular edema. One patient required additional treatment with Ozurdex during follow-up, further improving CME. Two of the cases required topical pressure lowering treatment, and none required filtering surgery. Iluvien could be an effective therapeutic option for persistent non-diabetic macular edema after vitrectomy or cataract surgery refractory to other intravitreal therapies, with the benefit of being able to provide longer recurrence-free periods.

Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies.

Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.

ILUVIEN® in diabetic macular edema that persists or recurs despite treatment: Results from the Retina.pt® RIVER audit.

PURPOSE: Persistent diabetic macular edema (DME) remains a problem in clinical practice, with many patients having a suboptimal response to the standard of care (SOC). Evidence supports the long-term efficacy of intravitreal fluocinolone acetonide (FAc) implant (ILUVIEN®) in patients that have responded sub-optimally, although there is still scarce data from real-world Portuguese practices. We aimed to monitor the current SOC in selected Portuguese practices prior to FAc implantation and then assess the long-term effectiveness and safety of the FAc implant. SETTINGS: The study included patient data from five Portuguese public hospitals. DESIGN: This was a non-interventional, multicenter audit of data collected from Retina.pt registry from patients with persistent or recurrent DME despite treatment. METHODS: Outcome measures included changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results were compared at regular times over 36 months. RESULTS: This study included 222 eyes from 152 patients. A significant decrease in BCVA (P < 0.001) and a significant increase in CMT (P = 0.013) were observed prior to FAc. A significant increase in BCVA was registered at 6 months after FAc implant administration (P < 0.001), which was maintained during follow-up. No relevant changes in IOP were observed. Treatment burden was reduced as a result of treatment with FAc (P < 0.001 for anti-VEGF, corticosteroids, or both treatments) in the full population. CONCLUSIONS: In Portuguese practice, data showed that pre-FAc implantation, some patients did not respond to SOC treatment and/or they were undertreated. Following FAc implant administration, there were rapid, sustained, long-term visual and anatomical improvements, and a marked reduction in treatment burden.

The Use of Sustained Release Intravitreal Steroid Implants in Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.

The treatment of non-infectious uveitis affecting the posterior segment of the eye has been revolutionized by the development of sustained-release corticosteroid implants over the past decade. Their use is now supported by healthcare systems that have licensed and commissioned them on the basis of the high-quality randomised controlled trials that formed part of their development and which have informed clinicians as to their benefits and risks. In particular, they have provided an alternative mode of treatment for patients who do not wish to be systemically immunosuppressed, or in whom such immunosuppression is less desirable, such as those with unilateral disease or those with concurrent illnesses such as diabetes mellitus, renal disease or osteoporosis that are negatively impacted by systemic corticosteroids or other immunosuppressive agents. In this article, we review the evidence for the use of the major licensed corticosteroid implants and assess the advantages and disadvantages of each.

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.

Changes in Macular Perfusion After ILUVIEN® Intravitreal Implant for Diabetic Macular Edema: An OCTA Study.

INTRODUCTION: The aim of this study was to investigate changes in macular perfusion in patients affected by diabetic macular edema (DME) and treated with ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg using optical coherence tomography angiography (OCTA). METHODS: This was a retrospective cohort study that included patients aged > 18 years with type 2 non-proliferative diabetic retinopathy (DR) and DME at baseline. All patients were treated with the ILUVIEN® implant. A minimum of two 6 × 6-mm OCTA scans were required to ensure that all cases had a baseline OCTA and an OCTA performed at 4 months of follow-up. Qualitative and quantitative comparisons were performed. RESULTS: Ten eyes from ten subjects were included in the analysis. Mean (± standard deviation) age of the study cohort was 57.1 ± 8.3 years. Mean parafoveal perfusion density (PD) at baseline was 64.1 ± 1.8% at baseline, increasing to 66.1 ± 2.9% (p = 0.013) at the 4-month follow-up visit. Mean parafoveal PD at baseline was 64.4 ± 2.1%, increasing to 65.2 ± 2.6% (p = 0.024) after 4 months. In the qualitative assessment, 60 regions (10 areas for each subject) were graded to assess changes in retinal perfusion between the baseline and follow-up visits. This assessment revealed that 24 regions (40.0%) were characterized by a qualitative increase in perfusion after treatment, while 22 (36.7%) and 14 (23.3%) regions were featured by a stability and reduction in retinal perfusion, respectively. CONCLUSION: OCTA analysis detects improvements in macular perfusion after treatment with ILUVIEN®. This improvement in macular perfusion may be associated with corticosteroid-related beneficial effects on leukostasis.

The impact of vitrectomy on outcomes achieved with 0.19 mg fluocinolone acetonide implant in patients with diabetic macular edema.

BACKGROUND: There is a lack of consensus on the use of intravitreal corticosteroid therapies in patients with diabetic macular edema (DME) and prior vitrectomized eyes in clinical practice. METHODS: Retro-IDEAL was a 3-year retrospective, multicenter study in patients with chronic DME (i.e. DME that persists or recurs despite treatment) treated with ILUVIEN® (0.2 µg daily fluocinolone acetonide intravitreal implant), who had suboptimal outcomes with first-line vascular endothelial growth-factor inhibitors and other DME therapies. RESULTS: A total of 81 eyes (63 patients) were included of which 39 eyes had undergone prior vitrectomy (PV group) while 42 eyes had not undergone prior vitrectomy (NPV). Baseline characteristics were balanced; however, more patients had proliferative diabetic retinopathy in the PV group vs. the NPV group (21.62% vs 9.38%, respectively). Over 36 months, mean visual acuity (VA) increased in both groups with a tendency for more ETDRS letters being gained in the NPV group (+5.33) vs. the PV group (+2.42). By month 36, central retinal thickness was reduced to ⩽300 µm in two-thirds of the eyes in both groups and the mean change from baseline in intraocular pressure was similar in both groups (+0.50 mmHg -0.75 mmHg; NPV and PV group). CONCLUSIONS: These long-term data suggest that the 0.2 µg/day FAc implant is effective in both vitrectomized and non-vitrectomized patients, with a manageable safety profile, and improved VA and reduced supplemental therapies for patients with a suboptimal response to first-line DME therapies. Clinicians may consider utilizing the FAc implant earlier in the DME disease process.

Fluocinolone Implant for Idiopathic Retinal Vasculitis, Aneurysms, and Neuroretinitis Syndrome: A Case Report.

Idiopathic retinal vasculitis, aneurysms, and neuroretinitis (IRVAN) syndrome is a rare and progressive disorder that predominantly affects both the eyes of young female individuals and can threaten visual function. Peripheral ischemia and macular exudation are common findings in patients. The treatment options include panretinal photocoagulation (PRP), systemic immunosuppression, and intravitreal antiangiogenic and corticosteroid therapy. Fluocinolone acetonide intravitreal implant is approved for the treatment of nonanterior noninfectious uveitis and diabetic macular edema (ME), with an estimated therapeutic duration of 3 years. We describe a case of IRVAN syndrome in a child with ME who had been previously treated with PRP, antiangiogenic therapy, and several dexamethasone intravitreal implants and received a fluocinolone acetonide intravitreal implant in her right eye. The patient showed stabilization of the visual acuity and a marked reduction of the macular thickness 1 month after the treatment. At 12-month follow-up, the patient required perifoveal focal photocoagulation due to a rebound of the ME. After 2 years of follow-up, visual acuity remains stable and macular retinal thickening under control. Local long-standing steroid therapy has proved to be quite efficient in controlling the progression of the disease in our patient.

The long-term efficacy and safety of fluocinolone acetonide intravitreal implant 190 µg (ILUVIEN®) in diabetic macular oedema in a multi-ethnic inner-city population.

PURPOSE: The purpose of this study is to report the long-term efficacy and safety of 0.19 mg fluocinolone acetonide intravitreal implant (ILUVIEN®) in pseudophakic eyes with diabetic macular oedema in a multi-ethnic patient cohort. METHODS: This is a single-centre retrospective analysis of patients with persistent diabetic macular oedema, despite previous anti-vascular endothelial growth factor and/or steroid treatment, treated with the ILUVIEN implant according to national guidelines. Patients with follow-up of less than 24 months were excluded. Best corrected visual acuity, central retinal thickness and intraocular pressure were evaluated at baseline and month 3, 12, 24 and 36 post-treatment. A sub-group analysis was performed on eyes with 36-month follow-up data. RESULTS: In total, 24 eyes (24 patients) completed at least 24 months of follow-up, of which 9 completed 36 months of follow-up. Three-fourths of the patients were black or South Asian (blacks, Asians and minority ethnic). Improvement in mean best corrected visual acuity was seen at year 1 and year 3 improving from 0.62 LogMAR at baseline to 0.55 LogMAR at year 1 and 0.47 LogMAR at year 3 (all p > 0.05). Mean central retinal thickness also showed a progressive reduction from 471 µm at baseline to 397 µm at year 1 and 339 µm at year 3 (all p < 0.05). Four eyes required intraocular pressure-lowering drops post-implant. Supplementary treatment for persistent or recurrent diabetic macular oedema was necessary in 13 eyes over the total study period of 3 years. Blacks, Asians and minority ethnic patients had a worse response compared with white patients. CONCLUSION: The ILUVIEN implant was effective and safe in the treatment of multi-ethnic patients with diabetic macular oedema refractory to conventional therapies, improving the vision and macular anatomy, without significant adverse events up to 36 months post-treatment.

Efficacy and safety of intravitreal Fluocinolone Acetonide microimplant (ILUVIEN®) in patients with chronic diabetic macular edema: 1 year follow-up.

PURPOSE: Evaluate the efficacy and safety of intravitreal 0.19 mg fluocinolone acetonide (FAc) micro implant in patients with chronic diabetic macular edema (cDME). METHODS: Prospective study recruiting subjects with cDME. Inclusion criteria: cDME for at least 2 years documented with OCT imaging; pseudophakia; previous treatments with laser photocoagulation and intravitreal injections of anti-VEGF and/or dexamethasone. Exclusion criteria: phakia; ocular hypertension; tractional component visible on OCT; glaucoma; previous vitrectomy. Outcome measures included best-corrected visual acuity (BVCA), intraocular pressure (IOP), and central macular thickness (CMT), measured 1, 3, 6, and 12 months post-injection. Data were compared with the Friedman test and significance was set at p < 0.05. RESULTS: A total of 18 eyes with a median duration of cDME of 45 months (25-118 months). The 77% of subjects either maintained or improved their BVCA. About 17% and 33% of subjects showed an improvement of 15 ETDRS letters or more at 3 and 12 months respectively. The 17% and 28% of subjects showed a CMT <250 microns at 3 and 12 months, respectively. The median change in CMT thickness was of -370 and -373.5 microns at 3 and 12 months post-injection respectively (p-value is 0.025). Changes in median IOP at 3 and 12 months post-injection were not statistically significant (p-value is 0.210). Ocular hypertension (OHT) was detected in two eyes (11%). CONCLUSION: The FAc micro implant has proved efficacy in improving and/or maintaining BVCA in 77% of patients with cDME up to 12 months post-injection. Ocular hypertension is the most common side effect but responds well to topical therapy.

Anterior migration of intravitreal fluocinolone acetonide (Iluvien®) implant in a pseudophakic eye with intact posterior capsule.

PURPOSE: To describe a case of spontaneous anterior migration of intravitreal fluocinolone acetonide (Iluvien®) implant in a pseudophakic eye with intact posterior capsule. OBSERVATION: A 60-year old woman with proliferative diabetic retinopathy underwent uneventful pars plana vitrectomy and phacoemulsification with posterior chamber intraocular lens (PCIOL) implants in both eyes. She developed diabetic macular edema (DME) in her right eye which failed to respond to repeated intravitreal injections of Aflibercept 2mg/0.05ml (Eylea®). The patient received an intravitreal Iluvien® implant to treat the recalcitrant DME after she showed a favorable temporary response to dexamethasone intravitreal implant (Ozurdex™).Six months later she presented with pain in the right eye due to elevated intraocular pressure (IOP). The Iluvien® implant was found to be dislodged into the anterior chamber (AC) in the presence of an intact posterior capsule and stable PCIOL implant. The migrated Iluvien implant was removed and IOP was controlled with a glaucoma drainage valve as it failed to respond to maximum anti-glaucoma medication. CONCLUSIONS AND IMPORTANCE: Intravitreal Iluvien® implant could migrate into the AC in a previously vitrectomized eyes in the presence of an intact posterior capsule.