Differential response to intravitreal dexamethasone implant in naïve and previously treated diabetic macular edema eyes

Zarranz‐Ventura, Javier; Romero-Nuñez, Barbara; Bernal-Morales, Carolina; Velázquez-Villoria, Daniel; Sala‐Puigdollers, Anna; Figueras‐Roca, Marc; Copete, Sergio; Distéfano, Laura; Boixadera, Anna; García‐Arumí, José; Adán, Alfredo

doi:10.1186/s12886-020-01716-2

Cited by 11 publications

(5 citation statements)

References 47 publications

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“…Zarranz-Ventura and colleagues investigated the differential response to intravitreal dexamethasone of treatment-naive and previously treated DME patients. Patients who were previously in their study had lower baseline VA compared to those in our study (37.5 letters) and showed less improvement [ 24 ]. Both study findings highlight the importance of early identification and treatment of DME patients.…”

Section: Discussionmentioning

confidence: 63%

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Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

Faes

Mishra

Lipkova

et al. 2023

JCM

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Importance: Diabetic macular edema (DME) is a major cause of vision loss in patients with diabetes mellitus. Intravitreal dexamethasone is a treatment option for patients unsuitable for or non-responsive to anti-angiogenic agents. Objective: To quantify visual and anatomical outcomes from an initial intravitreal dexamethasone injection over the expected 6-month period of dexamethasone release by the implant. Design and enrolment: This is a retrospective cohort study using electronic medical records of patients reviewed between 1 January 2012 and 1 April 2022. Setting: A tertiary eye-care center in London, United Kingdom; Moorfields Eye Hospital National Healthcare System Foundation Trust. Participants: The cohort comprised 418 adult patients with DME who received an initial treatment of 700 µg intravitreal dexamethasone in the study period. Of these, 240 patients met the inclusion criteria of ≥2 hospital visits following initial injection (≥1 beyond 6 months) and no previous ocular corticosteroid treatment or missing assessment at baseline. Exposure(s): Intravitreal dexamethasone implant (700 µg). Main Outcome(s) and Measure(s): Probability of a positive visual outcome, defined as ≥5 or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS)-letter gain after treatment when compared to baseline (Kaplan–Meier models). Results: From the initial intravitreal dexamethasone injection alone, we observed a >75% chance of gaining ≥5 ETDRS letters and >50% chance of gaining ≥10 ETDRS letters within 6 months. There was less than a 50% chance of sustaining either positive visual outcome beyond 4 months. Conclusions and Relevance: Most patients can be expected to have a positive visual outcome following an initial injection of dexamethasone implants that subsides within 4 months. Real-world re-treatment was observed to be delayed until after visual benefits were lost in half of the cohort. Further research will be needed to study the effects of delays in re-treatment.

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Section: Discussionmentioning

confidence: 63%

“…Zarranz-Ventura and colleagues reported a mean retreatment injection interval of 10 months for pre-treated DME patients after an initial injection in their retrospective cohort [ 24 ]. In our cohort, less than 50% of patients went on to receive retreatment by 10.5 months.…”

Section: Discussionmentioning

confidence: 99%

Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

Faes

Mishra

Lipkova

et al. 2023

JCM

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“…The Ozurdex IV implant has shown better functional and morphological results in treatment-naïve and in recent DME eyes [ 104 , 105 , 110 , 111 , 112 ], as well as when it was administered at need as opposed to a fixed regimen of 5 or 6 months of interval between re-injections [ 110 , 113 ]. The incidence of IOP elevation after the Ozurdex intravitreal implant ranges from 8% and 38% of cases [ 42 , 100 , 101 , 102 , 103 , 104 , 107 , 108 , 110 , 114 , 115 , 116 , 117 ].…”

Section: Corticosteroids For the Management Of Dmementioning

confidence: 99%

“…Better functional results in naïve eyes, with less DME duration and better glycemic control IOP rise of >25 mmHg in 8% of eyes The peak of improvement was achieved 3 months after the injection and dissipated until 6 months Rajesh et al, 2020 (International Ozurdex Study Group) [ 117 ] 0.7 mg DEX IV implant (Ozurdex) Multicenter retrospective observational real-life 2736 ME eyes (DME in 52% of cases, RVO, uveitis) Evaluation of the safety profile of Ozurdex insert 6–102 months n.a. IOP > 25 mmHg in 26% of eyes; 0.5% required glaucoma surgery; cataract development in 47% of cases; 32.5% of eyes required cataract surgery; endophthalmitis, retinal detachment, and vitreous hemorrhages < 0.1% of eyes Zarranz-Ventura et al, 2020 [ 112 ] 0.7 mg DEX IV implant (Ozurdex) Retrospective observational real-life 203 naïve-treatment and non-naïve DME eyes Comparison of efficacy and safety of 0.7 mg DEX IV implant between treatment-naïve and non-naïve DME eyes 2 years Naïve eyes had better functional and anatomical results, with lower number of re-injections and longer time to re-treatment Comet et al, 2021 (INVICTUS study) [ 122 ] 0.7 mg DEX IV implant (Ozurdex); ranibizumab IV injection; aflibercept IV injection Prospective non randomized observation real-life study 70 treatment-naïve CIDME eyes Comparison of efficacy of Ozurdex IV implant, ranibizumab or aflibercept IV injection 1 year Similar functional results amogst groups; better anatomical outcomes with Ozurdex n.a. Veritti et al, 2021 [ 126 ] 0.7 mg DE...…”

Section: Figure A1mentioning

confidence: 99%

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

Salvetat,

Pellegrini,

Spadea

et al. 2024

JCM

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Diabetic macular edema (DME) is a common complication of diabetes mellitus and a leading cause of visual impairment worldwide. It is defined as the diabetes-related accumulation of fluid, proteins, and lipids, with retinal thickening, within the macular area. DME affects a significant proportion of individuals with diabetes, with the prevalence increasing with disease duration and severity. It is estimated that approximately 25–30% of diabetic patients will develop DME during their lifetime. Poor glycemic control, hypertension, hyperlipidemia, diabetes duration, and genetic predisposition are recognized as risk factors for the development and progression of DME. Although the exact pathophysiology is still not completely understood, it has been demonstrated that chronic hyperglycemia triggers a cascade of biochemical processes, including increased oxidative stress, inflammation, activation of vascular endothelial growth factor (VEGF), cellular dysfunction, and apoptosis, with breakdown of the blood-retinal barriers and fluid accumulation within the macular area. Early diagnosis and appropriate management of DME are crucial for improving visual outcomes. Although the control of systemic risk factors still remains the most important strategy in DME treatment, intravitreal pharmacotherapy with anti-VEGF molecules or steroids is currently considered the first-line approach in DME patients, whereas macular laser photocoagulation and pars plana vitrectomy may be useful in selected cases. Available intravitreal steroids, including triamcinolone acetonide injections and dexamethasone and fluocinolone acetonide implants, exert their therapeutic effect by reducing inflammation, inhibiting VEGF expression, stabilizing the blood-retinal barrier and thus reducing vascular permeability. They have been demonstrated to be effective in reducing macular edema and improving visual outcomes in DME patients but are associated with a high risk of intraocular pressure elevation and cataract development, so their use requires an accurate patient selection. This manuscript aims to provide a comprehensive overview of the pathology, epidemiology, risk factors, physiopathology, clinical features, treatment mechanisms of actions, treatment options, prognosis, and ongoing clinical studies related to the treatment of DME, with particular consideration of intravitreal steroids therapy.

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“…Intravitreal corticosteroids for DMO are supported by a strong evidence base. Dexamethasone implant offers efficacy for up to approximately 6 months and is supported by long-term data from randomised controlled trials including the MEAD study [ 13 – 17 ] and by real world evidence [ 18 – 21 ]. Fluocinolone acetonide implant offers efficacy for up to approximately 3 years is also supported by long-term data from the randomised controlled FAME study [ 17 , 22 – 24 ] and by real world evidence, much of which is from the UK [ 25 – 33 ].…”

Section: Introductionmentioning

confidence: 99%

Suboptimal outcomes and treatment burden of anti-vascular endothelial growth factor treatment for diabetic macular oedema in phakic patients

Rennie

Lotery

Payne

et al. 2023

Eye

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Objectives In England and Wales, treatment options were limited for patients with diabetic macular oedema (DMO) with phakic eyes that failed anti-vascular endothelial growth factor (anti-VEGF) treatment pre-2022. This study aimed to quantify the response to, and treatment burden of, anti-VEGF treatment in phakic eyes. Methods Retrospective, cohort study using electronic patient record data from two UK centres between 2015 and 2020. Primary objective was proportion of phakic eyes with a suboptimal response after initial 6 months of anti-VEGF treatment. Data were available for 500 eyes from 399 patients. Results At 6 months significantly more eyes had a suboptimal response to anti-VEGF treatment: 65.8% (95% CI 61.5–70.0%) vs 34.2% (95% CI 30.0–38.5%), p < 0.0001. Baseline visual acuity (VA) predicted VA outcome, however, despite greater gains in eyes with poorer VA, such eyes did not achieve the same VA levels as those who started treatment with better VA. Only 53.6% of eyes had more than three injections in the first 6 months indicating difficulties in delivering high volume/high frequency treatment. Treatment and review burden were similar over the following years regardless of response to anti-VEGF treatment. Conclusions Data confirm previous real world evidence around response to anti-VEGF treatment, importance of baseline VA and frequency of injections in predicting outcomes in a UK setting. Continuing treatment beyond 6 months in suboptimal responders imposes unnecessary treatment burden without significant change in VA. In suboptimal responders, consideration of early switch to longer acting steroid treatments may help to reduce treatment burden, whilst maintaining or improving vision.

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Differential response to intravitreal dexamethasone implant in naïve and previously treated diabetic macular edema eyes

Cited by 11 publications

References 47 publications

Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

Visual and Anatomical Outcomes of a Single Intravitreal Dexamethasone in Diabetic Macular Edema: An 8 Year Real-World Study

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

Suboptimal outcomes and treatment burden of anti-vascular endothelial growth factor treatment for diabetic macular oedema in phakic patients

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