Anti–Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in a Real-World Clinical Setting

Maggio, Emilia; Sartore, Mauro; Attanasio, Marcella; Maraone, Giorgia; Guerriero, Massimo; Polito, Antonio; Pertile, Grazia

doi:10.1016/j.ajo.2018.08.004

Cited by 60 publications

(53 citation statements)

References 51 publications

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“…In accordance with the routine practice for patients treated with intravitreal injections at Sacro Cuore Hospital [13], at baseline all patients underwent a complete ophthalmologic examination, including medical history, BCVA evaluation, slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, dilated fundus examination with a 90 diopters indirect lens, optical coherence tomography (spectral domain OCT-SLO Heidelberg Engineering, Heidelberg, Germany) and fluorescein angiography (FA) with the Heidelberg Retina Angiograph (HRA). BCVA was measured by Snellen visual charts and converted to logarithm of the minimum angle of resolution (logMAR) units for statistical analysis.…”

Section: Treatment Protocol and Evaluation Proceduresmentioning

confidence: 99%

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes

Maggio

Mete

Maraone

et al. 2020

Journal of Ophthalmology

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Purpose. To report the long-term visual and anatomic outcomes of intravitreal injections for macular edema (ME) secondary to retinal vein occlusion (RVO) in a real-life clinical setting. Design. Retrospective interventional case series. Methods. A total of 223 consecutive eyes with ME secondary to RVO, treated with the first three intravitreal Ranibizumab or dexamethasone injections between August 2008 and September 2018, were enrolled in the study. Subsequent retreatment was guided by best-corrected visual acuity (BCVA) and central macular thickness (CMT) measurements, aimed at achieving macular fluid regression and BCVA stability. BCVA and CMT were recorded at baseline and at subsequent annual time points. The mean number of injections administered each year and the incidence of adverse events were recorded. Results. The mean BCVA and CMT at baseline were 0.79 logMar (SD 0.71) and 615.7 μm (SD 257.5), respectively. The mean follow-up (FU) period was 47.8 months (min 12–max 120). At 12 months, the mean BCVA and CMT had significantly improved to 0.62 logMar (SD 0.68; p<0.0001) and 401.04 μm (SD 183.8; p<0.0001). Improvements remained significant at the final FU visit. Eyes with BRVO and nonischemic RVO showed significantly better visual outcomes when compared to eyes with CRVO and ischemic RVO, over the entire FU period. An average of 4.08 (SD 2.1) Ranibizumab and 1.5 (SD 0.6) Ozurdex injections were administered over the first 12 months. The number of injections decreased thereafter progressively. One eye with CRVO developed endophthalmitis and one with BRVO developed an intraocular pressure increase that was refractory to topical medications and ultimately treated with trabeculectomy. Conclusion. Intravitreal Ranibizumab and/or dexamethasone injections were found to be effective at inducing a long-lasting improvement of BCVA and CMT in a real-life clinical setting. A safety profile similar to that already well-established in Ranibizumab and dexamethasone treatment was observed, as well as a steady decrease in the number of intraocular injections required. The results support intravitreal treatments for BRVO and CRVO in patient populations with similar characteristics in similar settings.

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Section: Treatment Protocol and Evaluation Proceduresmentioning

confidence: 99%

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes

Maggio

Mete

Maraone

et al. 2020

Journal of Ophthalmology

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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%

“…In clinical settings, the frequency of anti-VEGF injections for diabetic macular oedema (DME) is less than in landmark studies. [1][2][3] In light of this, there is increasing controversy regarding the extent to which this negatively impacts functional and anatomical outcomes in real-life cohorts. 4 The worldwide prevalence of diabetes mellitus (DM) is expected to rise from 415 million in 2015 to 642 million in 2040.…”

Section: Introductionmentioning

confidence: 99%

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<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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“…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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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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Anti–Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in a Real-World Clinical Setting

Cited by 60 publications

References 51 publications

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes

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

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

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