scholarly journals Optical Coherence Tomography Biomarkers - Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19 mg Fluocinolone Acetonide Implant

2021 ◽  
Author(s):  
Bernardete Pessoa ◽  
André Ferreira ◽  
João Leite ◽  
João Figueira ◽  
Angelina Meireles ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Subretinal Fluid ◽  
Structural Features ◽  
Fluocinolone Acetonide ◽  
Functional Improvement ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Refractory Diabetic Macular Edema ◽  
Fluocinolone Acetonide Implant

Background: The 0.19 mg fluocinolone acetonide (FAc) implant (ILUVIEN®; Alimera Sciences Ltd, Hampshire, UK) was approved for the treatment of vision impairment associated with chronic and refractory diabetic macular edema (DME). Objectives: To quantitatively assess functional and structural features in non-vitrectomized and vitrectomized DME patients after being treated with a FAc implant Methods: Retrospective review of patients with DME receiving single intravitreal injection of the FAc implant. The study was designed to analyze the presence of quantitative structural OCT biomarkers at baseline and 12 months after FAc therapy according to vitreous status. Results: A total of 41 eyes from 30 patients were included in this study. At 12 months post-injection, vitrectomized patients had a lower central foveal thickness (CFT, p=0.017) and fewer hyperreflective dots (HRD, p=0.028) compared with non-vitrectomized. Thirty (73%) patients presented a significant functional improvement with 17 (42%) increasing at least 15 ETDRS letters. Overall, 22 (54%) eyes had a complete resolution of DME at 12 months visit. Patients who needed additional therapy had a higher prevalence of subretinal fluid (SRF, 42% vs 3% p=0.005) at baseline. Conclusions: This study supports the effectiveness of the FAc implant and reports significant changes at 12 months post-FAc injection.

scholarly journals Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN® clinical evidence study in Portugal

2020 ◽  
Vol 12 ◽  
pp. 251584142091776
Author(s):  
Angela Carneiro ◽  
Angelina Meireles ◽  
João Paulo Castro Sousa ◽  
Carla Teixeira
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Clinical Evidence ◽  
Fluocinolone Acetonide ◽  
Foveal Thickness ◽  
Time Points ◽  
Central Foveal Thickness ◽  
Study Population ◽  
Fluocinolone Acetonide Implant

Introduction: The ILUVIEN® (fluocinolone acetonide) Clinical Evidence in Portugal (ICE-PT) study is a retrospective, multicenter, observational study evaluating the effectiveness and safety of the FAc implant in patients with diabetic macular edema. Methods: Patients included in this study had received the 0.2 µg/day fluocinolone acetonide implant for the treatment of diabetic macular edema and had measurements of visual acuity and retinal thickness assessed by optical coherence tomography for at least 12 months pre- and post-fluocinolone acetonide implant administration, with ⩾2 follow-up visits. Outcomes measured included visual acuity, central foveal thickness, and intraocular pressure. Results: There was a significant increase in mean visual acuity compared with baseline at 3, 6, 9, and 12 months post-fluocinolone acetonide in both the overall study population and the pseudophakic subgroup ( p < 0.05 at all time points in both groups). A significant reduction in mean central foveal thickness compared with baseline was seen in the overall study population at 3, 6, 9, and 12 months post-fluocinolone acetonide ( p < 0.05 at all time points). At 12-month post-fluocinolone acetonide, a small but significant intraocular pressure increase of 1.0 mmHg was seen in the overall study population. Conclusion: The results of this analysis show that switching from the current standard of care to the fluocinolone acetonide implant leads to beneficial effects in terms of vision and retinal structure in patients with diabetic macular edema and that patients benefited from FAc implant administration, regardless of lens status.

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.

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 Comparison of Intravitreal Dexamethasone Implant and Ranibizumab in Vitrectomized Eyes with Diabetic Macular Edema

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jia-Kang Wang ◽  
Tzu-Lun Huang ◽  
Pei-Yao Chang ◽  
Wei-Ting Ho ◽  
Yung-Ray Hsu ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Glycosylated Hemoglobin ◽  
Dexamethasone Implant ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Intravitreal Dexamethasone Implant ◽  
Intravitreal Dexamethasone ◽  
Treatment Number

Purpose. This retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution. Methods. Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6. Results. Twenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ ( p > 0.05 ). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 ( p < 0.05 ). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p = 0.04 ), more mean visual gain (−0.30 logMAR vs. −0.15 logMAR, p = 0.02 ), lower mean final CFT (310.9 μm vs. 384.2 μm, p = 0.04 ), and larger mean CFT decrease (−150.0 μm vs. −60.1 μm, p = 0.03 ) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001 ) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p = 0.0002 ) were demonstrated in the IDI group than those in the IVR group. Conclusion. We concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.

scholarly journals Differentiating features of OCT angiography in diabetic macular edema

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Reza Mirshahi ◽  
Hamid Riazi-Esfahani ◽  
Elias Khalili Pour ◽  
Kaveh Fadakar ◽  
Parsa Yarmohamadi ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Optical Coherence Tomography Angiography ◽  
Vascular Density ◽  
Diabetic Patients ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Capillary Plexus ◽  
Superficial Capillary Plexus

AbstractThe purpose of current study was to evaluate different optical coherence tomography angiography (OCTA) metrics in eyes with diabetic retinopathy with and without diabetic macular edema (DME). In this retrospective study, macular OCTA images of eyes with non-proliferative or proliferative diabetic retinopathy were evaluated. Vascular density, vascular complexity and non-perfusion densities were compared between eyes with and without DME. One-hundred-thirty-eight eyes of 92 diabetic patients including 49 eyes with DME were included. In multivariate analysis, the presence of DME was positively associated with geometric perfusion deficit (GPD) in superficial capillary plexus (SCP), capillary non-perfusion (CNP) of SCP, and GPD in deep capillary plexus (DCP) (all P < 0.05). In eyes with DME, central foveal thickness was associated with VD ratio (SCP/DCP) (P = 0.001) and FAZ area (P = 0.001). In conclusion, in eyes with diabetic retinopathy, the presence of DME was associated with more extensive capillary non-perfusion compared to those with no macular edema.

scholarly journals Efficacy of 0.2 μg/day fluocinolone acetonide implant (ILUVIEN) in eyes with diabetic macular edema and prior vitrectomy

Eye ◽  
2017 ◽  
Vol 31 (5) ◽  
pp. 684-690 ◽  
Author(s):  
A Meireles ◽  
C Goldsmith ◽  
I El-Ghrably ◽  
A Erginay ◽  
M Habib ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Fluocinolone Acetonide ◽  
Fluocinolone Acetonide Implant
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