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.

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

2021 ◽  
pp. 112067212110147
Author(s):  
Albert J Augustin ◽  
Silvia Bopp ◽  
Martin Fechner ◽  
Frank G Holz ◽  
Dirk Sandner ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Disease Process ◽  
Fluocinolone Acetonide ◽  
Vascular Endothelial ◽  
First Line ◽  
Intravitreal Implant ◽  
Fluocinolone Acetonide Implant ◽  
Endothelial Growth Factor ◽  
The Impact

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.

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.

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 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 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.

Sign in / Sign up

Export Citation Format

Share Document