Vision Outcomes Following Anti–Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice

Holekamp, Nancy M.; Campbell, Joanna; Almony, Arghavan; Ingraham, Herbert J.; Marks, Steven J.; Chandwani, Hitesh; Cole, Ashley L.; Kiss, Szilárd

doi:10.1016/j.ajo.2018.04.010

Cited by 85 publications

(80 citation statements)

References 27 publications

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“…It has been shown that patients generally received less injections than that given in clinical trials for n-AMD [30,31], DMO and RVOs [31][32][33]. This limits the effectiveness of anti-VEGF therapy in retinal vascular diseases [30][31][32][33][34][35][36].…”

Section: Limitations Of Anti-vegf Agents In the Treatment Of Retinal mentioning

confidence: 99%

Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases

Seah

Zhao

Lin

et al. 2020

Eye

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Anti-vascular endothelial growth factors (anti-VEGF) have become the most common treatment modality for many retinal diseases. These include neovascular age-related macular degeneration (n-AMD), proliferative diabetic retinopathy (PDR) and retinal vein occlusions (RVO). However, these drugs are administered via intravitreal injections that are associated with sight-threatening complications. The most feared of these complications is endophthalmitis, a severe infection of the eye with extremely poor visual outcomes. Patients with retinal diseases typically have to undergo multiple injections before achieving the desired therapeutic effect. Each injection incurs the risk of the sight-threatening complications. As such, there has been great interest in developing sustained delivery platforms for anti-VEGF agents to the posterior segment of the eye. In recent years, there have been various strategies that have been conceptualised. These include non-biodegradable implants, nano-formulations and hydrogels. In this review, the barriers of drug delivery to the posterior segment of the eye will be explained. The characteristics of an ideal sustained delivery platform will then be discussed. Finally, the current available strategies will be analysed with the above-mentioned characteristics in mind to determine the advantages and disadvantages of each sustained drug delivery modality. Through the above, this review attempts to provide an overview of the sustained delivery platforms in their various phases of development.These authors contributed equally: Ivan Seah Yu Jun, Zhao Xin Xin 1234567890();,:1234567890();,:

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Section: Limitations Of Anti-vegf Agents In the Treatment Of Retinal mentioning

confidence: 99%

Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases

Seah

Zhao

Lin

et al. 2020

Eye

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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%

<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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“…In addition, the number of injections was generally greater in patients in RCTs, who had greater letter gains compared with patients in real-world studies. An analysis of 1-year visual acuity outcomes from electronic medical records suggests that infrequent dosing might compromise the extent of vision improvement gained with anti-VEGF therapy during the first 12 months of treatment [18]. A comparison of DME trials shows that fixed dosing regimens [55] or strict PRN regimens with clear retreatment criteria [48] help to maximize the gains in BCVA, leading to optimal outcomes for patients.…”

Section: Discussionmentioning

confidence: 99%

Impact of Intravitreal Ranibizumab Therapy on Vision Outcomes in Diabetic Macular Edema Patients: A Meta-Analysis

Falcão

2019

Ophthalmologica

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Purpose: Evaluation of the impact of the injection frequency of ranibizumab on best-corrected visual acuity (BCVA) outcomes in patients with diabetic macular edema (DME). Methods: A meta-analysis of randomized controlled trials (RCTs) and real-world studies was performed to quantify the effect of ranibizumab treatment on BCVA and central foveal thickness (CFT) in DME as well as the relationship between the number of injections and the change in BCVA/CFT. Results: All combined sources (29 RCTs and 11 real-life studies) showed a significant increase in BCVA from baseline following anti-vascular endothelial growth factor (VEGF) treatment (8.2, 9.4, and 10.3 ETDRS letters gained after 12, 24, and 36 months of ranibizumab treatment, respectively). The largest changes in BCVA were observed in RCTs and the smallest in real-life studies at 12 months. A significant relationship was found between the number of injections and change in BCVA at 12 months. Conclusions: Inferior vision outcomes were observed in clinical practice compared with RCTs and might be partly attributable to administration of fewer anti-VEGF injections. Physicians should be aware that early and appropriate anti-VEGF treatment regimens are necessary to obtain the results reported in RCTs and help prevent irreversible vision loss in DME patients.

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Vision Outcomes Following Anti–Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice

Abstract: DME patients receiving anti-VEGF therapy in clinical practice undergo less frequent monitoring and intravitreal injections, and achieve inferior vision outcomes to patients in landmark clinical trials.

Cited by 85 publications

References 27 publications

Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases

Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases

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

Impact of Intravitreal Ranibizumab Therapy on Vision Outcomes in Diabetic Macular Edema Patients: A Meta-Analysis

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