Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes

AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). METHODS: This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected. RESULTS: Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. CONCLUSION: This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.

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Rapid response to dexamethasone intravitreal implant in diabetic macular edema

European Journal of Ophthalmology ◽

10.5301/ejo.5000989 ◽

2017 ◽

Vol 28 (1) ◽

pp. 74-79 ◽

Cited By ~ 4

Author(s):

Giuseppe Lo Giudice ◽

Antonio Avarello ◽

Gianluca Campana ◽

Alessandro Galan

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Secondary Outcome ◽

Dexamethasone Intravitreal Implant ◽

Clinical Series ◽

Intravitreal Implant ◽

Early Effects ◽

Sd Oct

Purpose: To evaluate the early effects of dexamethasone (DEX) intravitreal implants in patients with diabetic macular edema (DME). Methods: This was a prospective, single-arm, interventional clinical series. Eighteen patients (18 eyes) with chronic/recalcitrant or naive DME were included. Patients underwent single DEX intravitreal implant. Clinical assessments, including ophthalmologic examination, central retinal thickness (CRT) measurement by spectral-domain optical coherence tomography (SD-OCT) scan, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were carried out at baseline, 1-3 hours, and then 3, 7, and 30 days after treatment. The main outcome was change in CRT on SD-OCT, while secondary outcome measures included visual acuity (VA) and changes in IOP following implant. Results: Mean CRT significantly decreased from 565 ± 171 µm at baseline to 310 ± 89 µm at end of follow-up (p<0.001), with reduction becoming evident 1-3 hours after injection. Mean BCVA also significantly improved 7 days and 30 days after treatment up to 0.14 logMAR (p<0.05). All patients had a controlled IOP after the injection with only 1/18 eyes having a transient increase in IOP during follow-up. Conclusions: This is the first study showing very early effects of DEX implants on CRT reduction and VA improvement in DME.

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Dexamethasone Intravitreal Implant at the Time of Cataract Surgery in Eyes with Diabetic Macular Edema

European Journal of Ophthalmology ◽

10.5301/ejo.5000920 ◽

2016 ◽

Vol 27 (4) ◽

pp. 433-437 ◽

Cited By ~ 20

Author(s):

Giacomo A. Panozzo ◽

Elena Gusson ◽

Giorgio Panozzo ◽

Giulia Dalla Mura

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Foveal Thickness ◽

Dexamethasone Intravitreal Implant ◽

Positive Effects ◽

Intravitreal Implant ◽

A Prospective Study

Purpose To determine the potential role of intraoperative dexamethasone intravitreal implant (DEX-I) in reducing diabetic macular edema (DME) worsening after phacoemulsification. Methods This was a prospective study on 19 eyes of 19 patients with type 2 diabetes mellitus with DME and cataract. Mean preoperative Early Treatment Diabetic Retinopathy Study visual acuity (VA) was 16.7 letters. Mean foveal thickness (FT) was 451 μm. The DME was naive in 11 eyes and refractory in 8 eyes. All eyes underwent a standard phacoemulsification and intraocular lens implantation; DEX-I was injected at the end of surgery. Follow-up was performed at 1 week and then monthly until DME recurrence (up to 8 months). Results At 1 week, mean VA improved by 15 letters (range 0-29 letters) and mean FT decreased by 147 μm (range 69-236 μm). Improvement consolidated at month 1, with a mean VA improvement of 18 letters (range 3-32 letters) and a mean improvement in FT of 193 μm (range 76-304 μm), remaining stable at month 2 after surgery in all eyes. The DME recurred in 1 eye at month 3, in 14 eyes (73.8%) between months 4 and 5, and after month 6 in 4 eyes (21%). Refractory DMEs demonstrated the same benefit but recurred earlier than naive ones (4 months versus 5.8 months, p<0.01). Conclusions Intraoperative DEX-I prevents DME worsening after phacoemulsification. Its positive effects last for at least 3 months.

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Effect of dexamethasone intravitreal implant for refractory and treatment-naïve diabetic macular edema in Taiwanese patients

Journal of the Chinese Medical Association ◽

10.1097/jcma.0000000000000483 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Jia-Kang Wang ◽

Tzu-Lun Huang ◽

Yung-Ray Hsu ◽

Pei-Yao Chang

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Dexamethasone Intravitreal Implant ◽

Intravitreal Implant ◽

Treatment Naïve

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Real-Life Management of Diabetic Macular Edema with Dexamethasone Intravitreal Implant: A Retrospective Analysis of Long-Term Clinical Outcomes

Journal of Ophthalmology ◽

10.1155/2020/4860743 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Massimo Nicolò ◽

Donatella Musetti ◽

Maria Marenco ◽

Lorenzo Cotti ◽

Monica Bonetto ◽

...

Keyword(s):

Macular Edema ◽

Retrospective Analysis ◽

Diabetic Macular Edema ◽

Real Life ◽

Time Interval ◽

Dexamethasone Intravitreal Implant ◽

First Line Therapy ◽

Line Therapy ◽

Functional Benefit ◽

Intravitreal Implant

Purpose. Inflammation plays a key role in the pathogenesis of diabetic macular edema (DME), and intravitreal corticosteroids are among the recommended therapies. The goal of this retrospective analysis was to describe outcomes with dexamethasone intravitreal implant (DEX implant) in real life. Methods. Medical digital records of DME patients treated with DEX implant and followed up for 3 years were analyzed. Treatment with DEX implant was started either as first-line therapy in pseudophakic patients and in patients with cardiovascular comorbidities or as second-line therapy in patients refractory to the inhibitor of the vascular endothelial growth factor (anti-VEGF) therapy. Analyzed outcomes included central macular thickness (CMT) and best-corrected visual acuity (BCVA). Mean number of implant injections per patient and mean duration of the interval between injections were also estimated. Results. Seventy-five patients (mean age 65.7 (±12.3) years; 53 phakic and 22 pseudophakic) with DME were included. Overall, 84 eyes were treated. Mean CMT improved from 380.1 (±100.3) µm at baseline to 306.8 (±77.0) µm at 36 months (p=0.0003). Mean BCVA improved for up to 6 months (p=0.08) and then started to decrease reaching values lower than baseline after 24 months. In pseudophakic patients, BCVA improvements were more pronounced and sustained up to 36 months (p=0.6). Over 36 months, each patient received on average 2.4 (±1.6) intravitreal injections of DEX implant. The time interval between consecutive injections was included between 180 and 240 days. No unexpected safety issues were reported. Conclusions. With fewer than 3 injections per patient over a 3-year period, DEX implant was able to improve anatomic outcomes in DME patients. Only pseudophakic eyes showed also a long lasting functional benefit at 36 months.

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Effect of dexamethasone intravitreal implant in vitrectomized and nonvitrectomized eyes of Taiwanese patients with treatment-naïve diabetic macular edema

Journal of the Formosan Medical Association ◽

10.1016/j.jfma.2020.04.014 ◽

2020 ◽

Vol 119 (11) ◽

pp. 1619-1625

Author(s):

Jia-Kang Wang ◽

Tzu-Lun Huang ◽

Pei-Yao Chang

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Dexamethasone Intravitreal Implant ◽

Intravitreal Implant ◽

Treatment Naïve

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Longitudinal Study of Sustained-Release Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Ophthalmologica ◽

10.1159/000446194 ◽

2016 ◽

Vol 235 (4) ◽

pp. 187-188 ◽

Cited By ~ 11

Author(s):

Isabelle Aknin ◽

Laurent Melki

Keyword(s):

Adverse Events ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Real Life ◽

Injection Rate ◽

Efficacy And Safety ◽

Serious Adverse Events ◽

Dexamethasone Intravitreal Implant ◽

Anti Vegf ◽

Intravitreal Implant

Observational studies are needed to confirm the long-term efficacy and safety of Ozurdex® intravitreal implant in real life. Among 29 patients with persistent diabetic macular edema (DME), of whom 14 (48%) patients did not have any previous treatments and 22 (76%) any previous antivascular endothelial growth factor (anti-VEGF) injections, significant visual acuity (VA) improvement was observed with a mean gain of 13.8 letters at month 6 (p < 0.0001), 12.7 letters at month 12 (p = 0.0032) and 16.5 letters at month 18 (p = 0.0313). During the follow-up, a total of 17 (59%) patients had a VA improvement of ≥15 letters. Significant central macular thickness decrease was observed with a mean reduction of 159.07 μm at month 6 (p < 0.0001), 181.8 μm at month 12 (p < 0.0001) and 236.17 μm at month 18 (p = 0.0313). No serious adverse events were reported. With a good efficacy and safety, manageable adverse events and an injection rate much lower compared to that of anti-VEGF, this study confirms the use of Ozurdex® for the treatment of persistent DME.

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

European Journal of Ophthalmology ◽

10.1177/1120672121992982 ◽

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.

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Evaluation of retinal inflammatory biomarkers after intravitreal steroid implant and Ranibizumab injection in diabetic macular edema

European Journal of Ophthalmology ◽

10.1177/11206721211029465 ◽

2021 ◽

pp. 112067212110294

Author(s):

Ilkay Kilic Muftuoglu ◽

Ecem Onder Tokuc ◽

Fatma Sümer ◽

V Levent Karabas

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Outer Nuclear Layer ◽

Plexiform Layer ◽

Retinal Layer ◽

Treatment Naïve ◽

The Mean ◽

The Individual ◽

Inflammatory Component

Purpose: To compare the efficacy of intravitreal (IV) ranibizumab (IVR) injection with IV dexamethasone implant (IVDEX) in treatment naive diabetic macular edema (DME) patients with inflammatory component. Materials and methods: Treatment naive DME eyes with subfoveal neurosensorial detachment (SND) and hyperreflective spots (HRS) were treated either three loading doses of IVR (18 eyes) or one dose of IVDEX (19 eyes). Central macular thickness (CMT), height of SND, the number of HRSs scattered on the individual retinal layers and photoreceptor integrity were assessed using spectral domain- optical coherence tomography scans over 3-months follow-up. Results: The mean change in best-corrected visual acuity (BCVA) was −0.11 ± 0.08 logMAR in IVDEX group and −0.04 ± 0.06 logMAR in IVR group at 1-month ( p = 0.011). IVDEX group showed statistically significant more increase in BCVA compared to those receiving IVR injections at 2-months ( p = 0.004) and 3-months ( p = 0.017) visits. Compared to baseline, the number of total HRSs and the number of HRSs at each individual inner retinal layer significantly decreased in both groups at all follow-up visits. However, IVDEX group showed more decrease in the total number of HRSs at 2- and 3-months ( p < 0.001 at 2-months, and p = 0.006 at 3-months) and in the mean number of HRSs located at inner nuclear layer–outer plexiform layer level ( p = 0.016 at 1-month, p < 0.001 at 2-months, and p < 0.001 at 3-months). After treatment, the number of HRSs on the outer nuclear layer showed some non-significant increase in both groups. Conclusion: HRSs tended to migrate from inner retina to the outer retina in DME eyes by treatment. Dexamethasone seemed to be more effective option in such cases with inflammatory component.

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