scholarly journals Real-world retrospective comparison of 0.19 mg fluocinolone acetonide and 0.7 mg dexamethasone intravitreal implants for the treatment of diabetic macular edema in vitrectomized eyes

2019 ◽  
Vol Volume 13 ◽  
pp. 1751-1759 ◽  
Author(s):  
João Coelho ◽  
Luísa Malheiro ◽  
João Melo Beirão ◽  
Angelina Meireles ◽  
Bernardete Pessoa
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Fluocinolone Acetonide ◽  
Retrospective Comparison

scholarly journals Diabetic Macular Edema Outcomes in Eyes Treated with Fluocinolone Acetonide 0.2 µg/d Intravitreal Implant: Real-World UK Experience

2017 ◽  
Vol 27 (3) ◽  
pp. 357-362 ◽  
Author(s):  
Ibraheem El-Ghrably ◽  
David H.W. Steel ◽  
Maged Habib ◽  
Daniela Vaideanu-Collins ◽  
Sridhar Manvikar ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Safety Profile ◽  
Treatment Options ◽  
Fluocinolone Acetonide ◽  
Efficacy And Safety ◽  
Large Hospital ◽  
The United Kingdom ◽  
Intravitreal Implant

Purpose To conduct an observational, multicenter study to evaluate real-world clinical efficacy and safety of the 0.2 µg/day fluocinolone acetonide (FAc) implant in the treatment of patients with chronic diabetic macular edema (DME) in 3 large hospital ophthalmology departments in the United Kingdom. Methods Fluocinolone acetonide implants were inserted into the study eyes following a suitable washout period; phakic eyes received FAc implant following cataract surgery. Follow-up visits took place 2-4 weeks postinjection and then at 3, 6, and 12 months; change in central macular thickness (CMT) from baseline was measured by optical coherence tomography and best-corrected visual acuity (BCVA) was also assessed. Adverse events and changes in intraocular pressure (IOP) were recorded in order to evaluate the safety profile for the FAc implant. Results Improvements in BCVA and CMT were observed from 3 months and sustained for the duration of observation. At 12 months, the overall mean change from baseline CMT was -126 μm and mean increase in BCVA from baseline was 5.1 letters. Increases in IOP following FAc implant were easily managed with IOP-lowering medication. Implant migration into the anterior chamber occurred in 2 eyes where prior vitrectomy had resulted in a posterior capsule defect; this was rectified and resolved. Conclusions The results of this study provide further efficacy and safety profile data for FAc implant treatment of chronic DME in a real-world clinical setting; the FAc implant appears to be a valuable therapeutic approach for patients with chronic DME who have suboptimal response to other treatment options.

scholarly journals Three-year results from the Retro-IDEAL study: Real-world data from diabetic macular edema (DME) patients treated with ILUVIEN® (0.19 mg fluocinolone acetonide implant)

2019 ◽  
Vol 30 (2) ◽  
pp. 382-391 ◽  
Author(s):  
Albert J Augustin ◽  
Silvia Bopp ◽  
Martin Fechner ◽  
Frank Holz ◽  
Dirk Sandner ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
Clinical Practices ◽  
Real World Data ◽  
Intravitreal Therapy ◽  
Fluocinolone Acetonide Implant ◽  
Endothelial Growth Factor

Introduction: The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany. Methods: This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies). Results: Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar percentage of patients prior to (22.2% of cases) and following (27.2%) treatment with the FAc implant. In the majority of cases, these elevations were managed effectively with IOP medications. Conclusions: Despite substantial amounts of prior intravitreal treatments – primarily with anti–vascular endothelial growth factor (VEGF) drugs – this real-world study showed that sustained structural and functional improvements can last for up to 3 years with a single FAc implant.

scholarly journals Fluocinolone acetonide for the treatment of chronic diabetic macular edema: an Italian real‐world experience

2019 ◽  
Vol 97 (S263) ◽  
Author(s):  
Piero Zollet ◽  
Luigi Capone ◽  
Rosangela Lattanzio ◽  
Francesco Bandello
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Fluocinolone Acetonide

scholarly journals Real-World Efficacy and Safety of Fluocinolone Acetonide Implant for Diabetic Macular Edema: A Systematic Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 72
Author(s):  
Laurent Kodjikian ◽  
Stephanie Baillif ◽  
Catherine Creuzot-Garcher ◽  
Marie-Noëlle Delyfer ◽  
Frédéric Matonti ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Case Reports ◽  
Rescue Therapy ◽  
Cataract Extraction ◽  
Daily Practice ◽  
Fluocinolone Acetonide ◽  
Efficacy And Safety ◽  
Management Algorithm

To assess real-world outcomes of fluocinolone acetonide (FAc) implant in treating diabetic macular edema (DME), a systematic literature review was conducted on PubMed in order to identify publications assessing the efficacy and safety of the FAc implant in DME in daily practice. Case reports and randomized controlled trials were excluded. Twenty-two observational real-world studies analyzing a total of 1880 eyes were included. Mean peak visual gain was +8.7 letters (11.3 months post-FAc injection) and was greater for lower baseline best corrected visual acuity (BCVA) and for more recent DME. Mean central retinal thickness (CRT) decreased 34.3% from baseline. 77.0% of the analyzed studies reported both BCVA improvement of at least five letters and a CRT decrease by 20% or more. Rescue therapy was needed more frequently when FAc was administered for chronic DME. FAc-induced ocular hypertension was reported in 20.1% of patients but only 0.6% needed surgery. Cataract extraction was performed in 43.2% of phakic patients. Adequate patient selection is essential for optimal FAc response and better safety profile. Currently positioned as second- or third-line treatment in the management algorithm, FAc implant decreases treatment burden and provides better letter gain when administered for more recent DME.

Switching to intravitreal fluocinolone acetonide implant for refractory diabetic macular edema: 12- and 24-month results

2021 ◽  
pp. 112067212199298
Author(s):  
Argyrios Chronopoulos ◽  
Panagiotis Chronopoulos ◽  
Agharza Ashurov ◽  
Christina Korb ◽  
Norbert Pfeiffer ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Fluocinolone Acetonide ◽  
Additional Treatment ◽  
Multicentric Study ◽  
Goldmann Tonometry ◽  
Refractory Diabetic Macular Edema ◽  
Intravitreal Implant ◽  
Fluocinolone Acetonide Implant

Purpose: To report visual and anatomical outcomes of chronic/refractory diabetic macular edema (DME) treated with intravitreal fluocinolone acetonide implant. Setting: Retrospective, one arm, multicentric study. Method: Between 2013 and 2018, 27 consecutive eyes of 25 patients with chronic/refractory DME were treated with a fluocinolone acetonide intravitreal implant. Best registered visual acuity (BRVA), central retinal thickness (CRT), and Goldmann tonometry intraocular pressure (IOP) were assessed at 12 and 24 months. The need for IOP lowering treatment as well as top-up therapy during the follow-up were also assessed. Results: The duration of DME prior to treatment in our study was 54 ± 24 months. The baseline mean BRVA of 0.7 ± 0.34 logMAR improved to 0.5 ± 0.3 ( p = 0.01) at 12 months and 0.46 ± 0.3 ( p = 0.04) at 24 months. At 12 months, BRVA improved in 14 eyes (52%), stabilized in 5 eyes (20%), and decreased in 3 eyes (11%). At 24 months, BRVA improved further in 6 eyes (24%), stabilized in 3 eyes (12%), and decreased in 6 eyes (24 %). Mean CRT decreased from 497 ± 176 to 349 ± 186 μm at 12 months ( p = 0.0005) and to 267 ± 104 μm at 24 months ( p = 0.001). Only five eyes required additional treatment for DME and only three eyes required treatment for raised IOP. Discussion: Our results show that the visual and the anatomical improvements achieved by a single injection of a fluocinolone acetonide implant were maintained up to 24 months with minimal additional therapy even in eyes with a long and heavy history; however, IOP monitoring remains essential.

Effectiveness and tolerability of the fluocinolone acetonide implant in patients with diabetic macular edema in UAE: 12-Month results

2021 ◽  
pp. 112067212098294
Author(s):  
Ahmed Mohammed Elbarky
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Surgical Intervention ◽  
Previous Treatment ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
Corrected Visual Acuity ◽  
Intravitreal Implant ◽  
Fluocinolone Acetonide Implant ◽  
Endothelial Growth Factors

Introduction: To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population. Methods: A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP). Results: Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; p < 0.0001), with 86% of eyes gaining ⩾15 letters at month 12. Similarly, CMT reduced significantly at month 1, and stabilized thereafter at months 3–12 (−171.5 ± 72.5 µm, −240.9 ± 74.2 µm, and −246.2 ± 93.4 µm, respectively; p < 0.0001). By month 12, 64% ( n = 14/22) of eyes had a CMT below 300 µm. Only 1 eye had an IOP ⩾ 21 mmHg at baseline and month 12. Five eyes required IOP lowering drops and 1 required IOP-lowering surgical intervention. Conclusion: In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.

Steroid Therapy in Diabetic Retinopathy and Diabetic Macular Edema

2018 ◽  
pp. 160-164
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vitreoretinal Surgery ◽  
Fluocinolone Acetonide ◽  
Intravitreal Triamcinolone ◽  
Intraocular Pressure Elevation ◽  
Risk Treatment ◽  
Therapeutic Alternatives ◽  
Endothelial Growth Factor

Diabetic macular edema (DME) is the leading cause of blindness in patients with diabetic retinopathy worldwide. Therapeutic alternatives now include focal/grid laser photocoagulation, vitreoretinal surgery, and intraocular injection of anti-angiogenic and steroid molecules. In patients with recalcitrant DME, especially in those cases when anti-vascular endothelial growth factor (VEGF) agents are contraindicated or a treatment regimen with fewer intravitreal injections is required, intravitreal administration of steroids represents a fundamental alternative. Three intravitreal corticosteroid options for DME treatment are currently available including the dexamethasone delivery system, the fluocinolone acetonide insert, and off-label intravitreal triamcinolone acetonide. All of these drugs are associated with the risk of cataract progression and intraocular pressure elevation. In patients unresponsive to anti-VEGF therapy, pseudophakic, at low risk for glaucoma, or who have significant cardiovascular risk, treatment with long-lasting intraocular steroids is suggested.

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