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.

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.

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 The Impact of Interval between Recurrence and Reinjection in Anti-VEGF Therapy for Diabetic Macular Edema in Pro Re Nata Regimen

2021 ◽  
Vol 10 (24) ◽  
pp. 5738
Author(s):  
Yoshihiro Takamura ◽  
Teruyo Kida ◽  
Hidetaka Noma ◽  
Makoto Inoue ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Functional Improvement ◽  
Vascular Endothelial ◽  
Anti Vegf ◽  
Group 3 ◽  
Pro Re Nata ◽  
Endothelial Growth Factor ◽  
The Impact ◽  
Deferred Group

Background: Pro re nata (PRN) regimen using anti-vascular endothelial growth factor (VEGF) agent is popular for the treatment of diabetic macular edema (DME). We investigated the influence of waiting time (WT) and interval between the date of recurrence of edema and re-injection on treatment efficacy. Methods: This retrospective study conducted at 7 sites in Japan enrolled patients who received intravitreal injection of ranibizumab (IVR) and aflibercept (IVA) in 1+PRN regimen. Enrolled patients were divided into 2 groups: prompt group (less than 1 week) and deferred group (3 weeks or more). Central retinal thickness (CRT) and best corrected visual acuity (BCVA) were measured every month for 1 year. Results: CRT in the deferred group was significantly higher than that in the prompt group at 2, 5, 6, 7, and 12 months (p < 0.05). BCVA in the prompt group was significantly better than that in the deferred group at 7, 10, and 12 months (p < 0.05). Conclusion: The prompt group was superior in anatomical and functional improvement of DME in anti-VEGF therapy than the deferred group. Our data suggests that shorter WT is recommended for better visual prognosis in the treatment for DME.

scholarly journals Combination Treatment of Diabetic Macular Edema with Anti-Vascular Endothelial Growth Factor and Steroids: Analysis of DRCR.net Protocol U

2018 ◽  
Vol 1 ◽  
pp. 2
Author(s):  
Cindy Ung ◽  
Kareem Moussa ◽  
Yoshihiro Yonekawa
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Diabetic Patients ◽  
Vascular Endothelial ◽  
First Line ◽  
Second Line Therapy ◽  
Anti Vegf ◽  
Endothelial Growth Factor

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients. Intravitreal anti-vascular endothelial growth factor (VEGF) therapy is considered the first-line treatment option in the management of DME with corticosteroids used as second-line therapy. The DRCR.net Protocol U study was a Phase II trial that sought to compare the combination of a steroid and anti-VEGF therapy to anti-VEGF monotherapy regarding visual acuity and anatomic outcomes. This review highlights the strengths, weaknesses, and clinical implications of this study.

Long-term Therapies for Diabetic Macular Edema

2012 ◽  
Vol 06 (04) ◽  
pp. 236 ◽  
Author(s):  
Andrew J Lotery ◽  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Safety Profile ◽  
Treatment Options ◽  
Fluocinolone Acetonide ◽  
Diabetic Patients ◽  
Sustained Drug Release ◽  
Improved Outcomes ◽  
Intravitreal Implant ◽  
Endothelial Growth Factor

Diabetic macular edema (DME) is one of the main causes of visual loss in diabetic patients. Although photocoagulation and intensive control of systemic metabolic factors have achieved improved outcomes, improvement is slow and some patients with DME continue to lose vision despite treatment. Pharmacological treatment options for DME include vascular endothelial growth factor (VEGF) antagonists such as ranibizumab, bevacizumab and pegaptanib and corticosteroids, whose multiple mechanisms of action include reduction of VEGF expression. Intravitreal delivery of these agents has shown efficacy in the treatment of DME but is associated with adverse effects including cataract progression and sustained rises in intraocular pressure. The physical characteristics and potent anti-inflammatory properties of fluocinolone acetonide (FAc) have led to its use in intravitreal implants. A number of intravitreal implants have been evaluated, of which the most effective at providing sustained drug release with an acceptable safety profile is the ILUVIEN® implant. This FAc intravitreal implant provides significant, long-lasting improvements in visual acuity for patients with chronic DME and has a manageable safety profile.

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