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

2016 ◽  
Vol 235 (4) ◽  
pp. 187-188 ◽  
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.

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

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.

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

2021 ◽  
Vol 14 (10) ◽  
pp. 1571-1580
Author(s):  
Pedro Neves ◽  
◽  
Inês Matias ◽  
João Rodrigues ◽  
Margarida Santos ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Demographic Data ◽  
Antiangiogenic Therapy ◽  
Real Life ◽  
Real World Data ◽  
Dexamethasone Intravitreal Implant ◽  
Intravitreal Implant ◽  
Treatment Naïve

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.

Dexamethasone Intravitreal Implant in Combination with Laser Photocoagulation for the Treatment of Diffuse Diabetic Macular Edema

Ophthalmology ◽  
2013 ◽  
Vol 120 (9) ◽  
pp. 1843-1851 ◽  
Author(s):  
David G. Callanan ◽  
Sunil Gupta ◽  
David S. Boyer ◽  
Thomas A. Ciulla ◽  
Michael A. Singer ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Laser Photocoagulation ◽  
Dexamethasone Intravitreal Implant ◽  
Intravitreal Implant ◽  
Diffuse Diabetic Macular Edema

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 Pharmacological Management of Diabetic Macular Edema in Real-Life Observational Studies

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Laurent Kodjikian ◽  
David Bellocq ◽  
Thibaud Mathis
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Observational Studies ◽  
Real Life ◽  
Pharmacological Management ◽  
Anti Vegf ◽  
Pubmed Database ◽  
Baseline Visual Acuity

Objectives of the Study. Summary of observational studies concerning the pharmacological management of diabetic macular edema (DME). Methods. A literature review was conducted using the PubMed database on 1 February 2018 to identify studies evaluating the efficacy of anti-VEGF and dexamethasone (DEX) implants for DME. Studies with more than 10 patients and follow-up of more than 6 months were selected. Analyses were carried out on the overall population and on subgroups defined according to baseline visual acuity (BVA) and the patients’ naïve or non-naïve status. Results. Thirty-two studies evaluating the efficacy of anti-VEGF and 31 studies evaluating the efficacy of DEX-implants were retained, concerning 6,842 and 1,703 eyes, respectively. A mean gain of +4.7 letters for a mean of 5.8 injections (mean follow-up: 15.6 months) and +9.6 letters for a mean of 1.6 injections (10.3 months) was found in the anti-VEGF and DEX-implant studies, respectively. Final VA appears to be similar for both treatment (62 letters for anti-VEGF, 61.2 letters for DEX-implant), and BVA appears lower for DEX-implant, which may partially explain the greater visual gain. The DEX-implant studies show greater gains in VA compared to the anti-VEGF studies, especially for higher BVA. Indeed, mean gains for the subgroups of patients with BVA<50 letters, 50<BVA<60 letters, and BVA>60 letters are +4.3, +5.8, and +3.1 letters, respectively, in the anti-VEGF studies and +10.5, +9.3, and +8.8 letters, respectively, in the DEX-implant studies. Regarding the patient’s initial status, only naïve status appears to confer the best functional response in DEX-implant studies. Conclusion. Observational studies investigating DEX-implant report clinically similar final VA when compared to anti-VEGF, but superior visual gains in real-life practice. This latter difference could be due to the better BVA, but also to the fact that less injections were administered in the anti-VEGF observational studies than in the interventional studies.

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