Treatment Efficacy and Compliance in Patients with Diabetic Macular Edema Treated with Ranibizumab in a Real-Life Setting

Best, Anne-Laurence; Fajnkuchen, Franck; Nghiem-Buffet, Sylvia; Grenet, Typhaine; Quentel, G; Delahaye-Mazza, Corinne; Cohen, Salomon Y.; Giocanti-Aurégan, Audrey

doi:10.1155/2018/4610129

Cited by 37 publications

(61 citation statements)

References 23 publications

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“…A change in VA of 10 and 15 letters are frequently considered when evaluating outcomes in DMO patients receiving anti-VEGF therapy. [13,15,20] Also in keeping with reported retrospective studies, the proportion of eyes in this cohort gaining ≥ 10 letters was greater than 30% and exceeded those who lost ≥ 10 letters at each of the annual time-points ( Supplemental Figure 3a ). [13,15,20] A similar trend was observed when considering the proportion of eyes which gained ≥ 15 letters, with 19.3%, 20.5%, 18.9%, and 21.3% of eyes observed at the annual time-points spanning 1 to 4 years following baseline (Supplemental Figure 3b ).…”

Section: Mean Visual Acuity Trends Are Similar To Existing Literaturesupporting

confidence: 85%

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An open-source dataset of anti-VEGF therapy in diabetic macular oedema patients over four years & their visual outcomes

Kern

Huemer

et al. 2019

Preprint

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PURPOSE: To evaluate visual acuity (VA) outcomes of intravitreal anti-vascular endothelial growth factor (VEGF) in diabetic macular oedema (DMO). METHODS: In this retrospective cohort study, electronic medical records for all patients undergoing intravitreal injections (IVI) in a tertiary referral centre between March 2013 and October 2018 were analysed. Treatment response in terms of visual acuity outcomes were reported for all eyes over a 4-year observation period. RESULTS: Our cohort includes 2616 DMO eyes of 1965 patients over 48 months. Cox proportional hazards modelling identified injection number (hazard ratio [HR] = 1.18), male gender (HR = 1.13), and baseline VA (HR = 1.09) as independent predictors to reach a favorable visual outcome of more than 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Half of our cohort reached 70 letters 1.9 months after starting anti-VEGF therapy. Of those that reached 70 letters, 50% fell below 70 by 14.7 months. CONCLUSION: To date, this is the largest single center cohort study and over the longest observation period reporting on real-life outcomes of anti-VEGF in DMO. We have made an anonymised version of our dataset available on an open-source data repository as a resource for all clinical researchers globally.

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Section: Mean Visual Acuity Trends Are Similar To Existing Literaturesupporting

confidence: 85%

“…A key example is that real-life practice features lower injection frequencies when compared to RCTs. [7][8][9][10][11][12][13][14][15][16] This is likely due to different treatment regimens (pro re nata and treat-and-extend) and reduced therapy adherence.…”

Section: Introductionmentioning

confidence: 99%

An open-source dataset of anti-VEGF therapy in diabetic macular oedema patients over four years & their visual outcomes

Kern

Huemer

et al. 2019

Preprint

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“…Several real-life studies have been published for ranibizumab in DME treatment. 2,15,17,18,[29][30][31][32] A commonality of these studies is that the number of injections, functional outcomes, and structural outcomes are comparatively worse than in the pivotal RCTs. Even though our study reports values that are consistent with the real-life data previously published for DME patients undergoing anti-VEGF treatment, direct comparison is impossible.…”

Section: Comparing Our Results To Published Real-life Datamentioning

confidence: 99%

“…24 Our results fit into the decrease in CRT after one year, which ranges between 20% and 30% from baseline, independently of baseline thickness. 2,15,17,29,32 Almost 90% of DME patients have a sponge-like structure on OCT which causes diffuse retinal swelling. 33 Therefore, both CRT and TVOL should be considered when observing treatment outcomes in eyes with DME.…”

Section: Comparing Our Results To Published Real-life Datamentioning

confidence: 99%

<p>Two Year Visual Acuity and Structural Outcomes in Patients with Diabetic Macular Oedema Treated with Intravitreal Aflibercept – A Retrospective Cohort Study</p>

Kern¹,

Schiefelbein²,

Fu³

et al. 2020

OPTH

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Purpose: To assess visual and anatomical outcomes of intravitreal aflibercept for clinically significant diabetic macular oedema (DME). Methods: For this retrospective single-center cohort study at a tertiary referral center, we performed a data warehouse query to identify 117 treatment-naive patients (139 eyes) undergoing intravitreal treatment with aflibercept for DME between January 2014 and May 2018. Changes in best-corrected visual acuity (BCVA) values (as measured with ETDRS letters), central retinal thickness (CRT) and total macular volume (TVOL) are reported over a two-year period at various time-points. Results: The total number of injections per study eye was 5.5 ± 1.4 after one and 8.7 ± 2.2 injections after two years. Baseline visual acuity (VA) was 60.1 ± 14.5 letters. A gain of 4.8 and 9.2 letters from baseline was observed after one and two years, respectively (both p ≤ 0.01). In comparison to the mean CRT at baseline (419 ± 174 µm), a CRT decrease was observed after one and two years of treatment (298 ± 115 µm and 319 ± 119 µm, respectively; both p ≤ 0.01). Similarly, TVOL decreased from 10.12 ± 2.05 mm 3 to 8.96 ± 0.96 mm 3 and 9.01 ± 1.29 mm 3 (both p ≤ 0.01). Conclusion: This study demonstrates that treating DME with intravitreal aflibercept yields positive functional and structural outcomes over a two-year period. However, we observed fewer injection numbers, along with inferior VA and structural outcomes than has been reported in randomized clinical trials. Our results show similar results as in patients treated with ranibizumab due to DME in real-life settings.

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“…18 However, there is evidence that the uptake of anti-VEGF by patients with DMO is significantly lower compared to patients with ARMD. [19][20][21] People with diabetes often have other co-morbidities that increase their need to attend hospital appointments, so completing an anti-VEGF treatment regime can be a significant additional burden. Patients receiving intravitreal injections report high levels of anxiety and significant psychological impact.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of interventions to increase uptake and completion of treatment for diabetic retinopathy in low- and middle-income countries: a rapid review protocol.

Bascarán

Mwangi

D’Esposito

et al. 2020

Preprint

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Background Vision loss due to diabetic retinopathy can largely be prevented or delayed through treatment. Patients with vision-threatening diabetic retinopathy are typically offered laser or intravitreal injections which often require more than one treatment cycle. However, treatment is not always initiated, or it is not completed, resulting in poor visual outcomes. Interventions aimed at improving the uptake or completion of treatment for diabetic retinopathy can potentially help prevent or delay visual loss in people with diabetes. Methods We will search MEDLINE, Embase, Global Health and Cochrane Register of Studies for studies reporting interventions to improve the uptake of treatment for diabetic retinopathy (DR) and/or diabetic macular oedema (DMO), compared with usual care, in adults with diabetes. The review will include studies published in the last 20 years in the English language. We will include any study design that measured any of the following outcomes in relation to treatment uptake and completion for DR and/or DMO: 1) Proportion of patients initiating treatment for DR and/or DMO among those to whom it is recommended, 2) Proportion of patients completing treatment for DR and/or DMO among those to whom it is recommended, 3)Proportion of patients completing treatment for DR and/or DMO among those initiating treatment, 4) Number and proportion of DR and/or DMO rounds from the recommended treatment protocol completed per patient. For included studies we will also report any measures of cost-effectiveness when available. Two reviewers will screen search results independently. Risk of bias assessment and data extraction will be done by one reviewer with verification of 10% of the papers by a second reviewer. The results will be synthesised narratively. Discussion This rapid review aims to identify and synthesise the peer-reviewed literature on the effectiveness of interventions to increase uptake and completion of treatment for DR and/or DMO in LMICs. The rapid review methodology was chosen in order to rapidly synthesise the available evidence to support program implementers and policy makers in designing evidence-based health programs, public health policy, and inform the allocation of resources. Rapid review registration OSF: osf.io/h5wgr

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Treatment Efficacy and Compliance in Patients with Diabetic Macular Edema Treated with Ranibizumab in a Real-Life Setting

Cited by 37 publications

References 23 publications

An open-source dataset of anti-VEGF therapy in diabetic macular oedema patients over four years & their visual outcomes

An open-source dataset of anti-VEGF therapy in diabetic macular oedema patients over four years & their visual outcomes

<p>Two Year Visual Acuity and Structural Outcomes in Patients with Diabetic Macular Oedema Treated with Intravitreal Aflibercept – A Retrospective Cohort Study</p>

Effectiveness of interventions to increase uptake and completion of treatment for diabetic retinopathy in low- and middle-income countries: a rapid review protocol.

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