Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA)

Schmidt‐Erfurth, Ursula; García-Arumí, José; Bandello, Francesco; Berg, Karina M.; Chakravarthy, Usha; Gerendas, Bianca S.; Jonas, Jost B; Larsen, Michael; Tadayoni, Ramin; Loewenstein, Anat

doi:10.1159/000458539

Cited by 550 publications

(699 citation statements)

References 156 publications

(178 reference statements)

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“…Schmidt-Erfurth et al [1] state that "… repeated treatment may be given after a year according to evidence of central fluid and visual acuity." This apparently relates to ILUVIEN re-injection, but it is important that the reader understands that retreatment with additional therapies (e.g., intravitreal anti-VEGF) is not restricted.…”

Section: Characteristicsmentioning

confidence: 99%

“…It is mentioned that "the official product label in Europe recommends additional treatments after one year and does not recommend administration to both eyes concurrently" [1] . However, this does not accurately reflect the SPC for ILUVIEN, which states: "It is recommended that an implant is not administered to both eyes at the same visit.…”

Section: Characteristicsmentioning

confidence: 99%

“…macular edema that is not responsive to other treatments" [1] . I would like to remind the readers that ILUVIEN (0.2 μg/ day of FAc) is approved in Europe for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies [2] .…”

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confidence: 99%

“…Moreover, real-world practice data show that anti-VEGF injections, as opposed to short-acting steroids, are repeatedly administered prior to intravitreal anti-VEGF injections [4] , and the logical next step is the utilization of a second-line corticosteroid therapy. Schmidt-Erfurth et al [1] also report the efficacy and safety profile for the FAME trials (FAME A and B; ClinicalTrials.gov Identifier NCT01304706). These are the pivotal ILUVIEN data upon which a European license was granted in 2012 and not 2014 as stated in the text.…”

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confidence: 99%

“…These are the pivotal ILUVIEN data upon which a European license was granted in 2012 and not 2014 as stated in the text. I would like to highlight the baseline visual acuity for the Dear Editor I recently read the "Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA)" published by SchmidtErfurth et al [1] that appeared in Ophthalmologica . The guidelines aimed to provide guidance on the management of diabetic macular edema (DME) in Europe based on available scientific evidence for currently used DME treatments.…”

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confidence: 99%

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ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

Hall¹

2017

Ophthalmologica

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Section: Characteristicsmentioning

confidence: 99%

Section: Characteristicsmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

Hall¹

2017

Ophthalmologica

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A Patient With Type 1 Diabetes, Visual Acuity Loss, and Retinal Thickening

2019

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A 24-year-old man presented with substantial loss of visual acuity in the left eye. He had been diagnosed with type 1 diabetes 5 years prior and had never been examined for diabetic retinopathy. At the initial examination, his hemoglobin A 1c level was 11.0% (to convert to the proportion of total hemoglobin, multiply by 0.01), suggesting a lack of compliance with his diabetic treatment regimen. His best-corrected visual acuity (BCVA) was 20/100 OS and 20/60 OD. On examination of the left eye, the anterior segments were unremarkable, with no neovascularization of the angle or iris. However, there was considerable retinal thickening, substantial capillary nonperfusion in the macular area, and a large area of disc neovascularization (in more than one-third of the disc area), with leakage on the disc associated with prepapillary neovascularization, as confirmed by fluorescein angiography (Figure 1A). Optical coherence tomography confirmed retinal thickening in the macular area (central subfield thickness [CST], 805 μm), with cystoid abnormalities throughout the retinal layers as well as subretinal fluid (Figure 1B). Diagnosis Center-involved diabetic macular edema and proliferative diabetic retinopathy What to Do Next C. Intravitreal anti-vascular endothelial growth factor injections and laser panretinal photocoagulationDiscussion Clinical Review & Education

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Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration

et al. 2023

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ImportanceAflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.ObjectiveTo establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).Design, Setting, and ParticipantsThis was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.InterventionParticipants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.Main Outcomes and MeasuresThe primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.ResultsThe mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.Conclusions and RelevanceIn this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.Trial RegistrationClinicalTrials.gov Identifier: NCT04450329

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Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA)

Cited by 550 publications

References 156 publications

ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

ILUVIEN in Diabetic Macular Edema: The Choice of Second-Line Corticosteroid Should Be Left to the Clinical Judgement of the Treating Physician

A Patient With Type 1 Diabetes, Visual Acuity Loss, and Retinal Thickening

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration

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