Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study

Singer, Michael; Fine, Howard F; Capone, Antonio; Maltman, John

doi:10.3928/23258160-20180601-07

Cited by 27 publications

(44 citation statements)

References 17 publications

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“…Unlike the current study, in which the interval between injections was set to 3 to 6 months, most real-life studies did not limit the interval between injections, with reported treatment intervals ranging up to 23 months. 17,24,26,28 Thus, the actual effect of the drug may be hindered by additional rescue treatments and the cumulative effect potentially lost, in turn rendering the definition of a series somewhat obsolete. Looking at the treatment effect over time within an injection series, this study demonstrated a pendular effect profile of improvement and deterioration in both visual acuity and anatomic outcome.…”

Section: Discussionmentioning

confidence: 99%

A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema

et al. 2020

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Purpose: To evaluate the efficacy, effect profile, and safety of dexamethasone implant on diabetic macular edema (DME) in a real-life setting, further comparing results by DME duration, previous treatment status, and diabetic control. Design: A multicenter, retrospective cohort of 340 DME eyes of 287 patients from 25 clinical sites from 8 countries. Methods: Data were analyzed in 2 perspectives: per injection, in which all measurements were grouped and baseline was defined as the day of injection, and thus the pharmacodynamics of single injections could be assessed; and injection series, defined as 2 or more injections with 3 to 6 months between injections analyzing the outcome 3 to 6 months after the last injection. Main Outcome Measures: Primary outcome was improvement of 15 or more letters in best-corrected visual acuity (BCVA) from baseline. Secondary outcomes included improvement of 10 letters or more in BCVA, change in central macular thickness (CMT), and time to maximum improvement and safety. Results: Overall, 762 injections were administered to 340 eyes of 287 patients. Injection series analysis included 171 series in 171 eyes of 150 patients, for a total of 444 injections, with a mean follow-up of 1.7AE0.8 years. Of the 762 injections analyzed per injection, 22.7% achieved a 15-letter or more improvement, and 37.8% achieved a 10-letter or more improvement. Mean time to peak improvement was 81.9AE39.7 days. Mean maximum change in CMT was e174AE171 mm. Overall, 7.6% lost 15 or more letters. More eyes with early DME gained 10 or more letters and fewer eyes lost 10 or more letters compared with eyes with late DME (47.4% vs. 33.9% [P ¼ 0.001] and 8.2% vs. 13.5% [P ¼ 0.029], respectively). Patients with controlled diabetes showed greater CMT reduction (P ¼ 0.0002). A higher percentage of treatment-naive patients gained 10 or 15 letter or more in BCVA (P ¼ 0.001 and P ¼ 0.006, respectively). Intraocular pressure elevation of more than 25 mmHg was found following 7.9% of injections; no endophthalmitis was reported. Conclusions: Dexamethasone implant is an effective and safe treatment for DME. Peak improvement was achieved 3 months after injection and dissipated thereafter. Clinicians and providers may consider shortening treatment intervals.

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Section: Discussionmentioning

confidence: 99%

A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema

et al. 2020

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“…In addition, percentage of patients who required IOP-lowering medication following the injection has been reported between 10.9% and 54%. IOP elevation is usually well-controlled with IOP-lowering medication in most of studies and the rate of patients who underwent glaucoma surgery is not reported more than 2% in any study [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] .…”

Section: Major Clinical Trials Evaluating I O P C H a N G E S A F T Ementioning

confidence: 87%

“…IOP elevation is considered a common adverse event that may occur after the administration. IOP outcomes in clinical trials of IDI are summarized in Table 1 [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] . Different studies have reported the rates of IOP of > 25 mmHg in patients who developed IOP elevation following IDI administration are ranged from 7.1% to 58.7%.…”

Section: Major Clinical Trials Evaluating I O P C H a N G E S A F T Ementioning

confidence: 99%

“…In a very recent study conducted by Ventura et al [28] , the authors evaluated the long-term (24 months) cumulative probability of IOP elevation associated with the IDI that was administered in various indications (DME, RVO, NIU). They suggested that IOP elevation was common, generally mild and well-tolerated.…”

Section: Major Clinical Trials Evaluating I O P C H a N G E S A F T Ementioning

confidence: 99%

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Intraocular Pressure Changes Following the Administration of Intravitreal Dexamethasone Implant: A Mini -Review

Kartı

Saatçi²

2019

International Journal of Ophthalmic Research

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“…e biodegradable implant releases dexamethasone into the vitreous over a period of ≤6 months [9]. e efficacy and safety of DEX implant have been investigated in randomized trials [3,[10][11][12], in head-to-head comparisons with anti-VEGF agents [13,14], and in a number of real-life studies [15][16][17][18][19]. In the MEAD trial, for example, DEX implant 0.7 mg or 0.35 mg provided substantial long-term improvements in visual acuity and central macular thickness (CMT) in patients with DME, with a mean of only 4 to 5 injections over 3 years [3].…”

Section: Introductionmentioning

confidence: 99%

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

Nicolò

Musetti

Marenco

et al. 2020

Journal of Ophthalmology

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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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Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study

Abstract: DEX used alone or with other DME therapy improved visual and anatomic outcomes in DME patients in clinical practice, with no new safety concerns. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:425-435.].

Cited by 27 publications

References 17 publications

A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema

A Collaborative Retrospective Study on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema

Intraocular Pressure Changes Following the Administration of Intravitreal Dexamethasone Implant: A Mini -Review

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

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