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. 2023 Jul 17:17:2013-2025.
doi: 10.2147/OPTH.S399981. eCollection 2023.

Characteristics and Treatment Patterns of Patients with Diabetic Macular Edema Non-Responsive to Anti-Vascular Endothelial Growth Factor Treatment in Ontario, Canada

Sohel Somani  1 , Keyvan Koushan  2 , Bijal Shah-Manek  3 , Daniel Mercer  4 , Thula Kanagenthiran  5 , Changgeng Zhao  5 , Ali Alobaidi  5
Affiliations

Characteristics and Treatment Patterns of Patients with Diabetic Macular Edema Non-Responsive to Anti-Vascular Endothelial Growth Factor Treatment in Ontario, Canada

Sohel Somani et al. Clin Ophthalmol. .

Abstract

Purpose: To understand the demographics, clinical characteristics, treatment patterns, visual and anatomic responses of patients with diabetic macular edema (DME) initially treated with anti-vascular endothelial growth factor (anti-VEGF) agents in the real-world clinical setting.

Patients and methods: This retrospective cohort study used electronic health records to identify consecutively presenting patients with DME who received their first documented anti-VEGF injection (index injection) on or after 1 October 2015 and before 30 September 2016 (index period) at 4 clinical sites in Ontario, Canada. Patients receiving anti-VEGF injections in the study eye were followed for ≥18 months. After the first 3 monthly injections, patients were classified as "responder" (≥20% reduction in central retinal thickness [CRT] from index date) or "nonresponder" (<20% reduction in CRT) to anti-VEGF treatment.

Results: At 12 months, change from baseline (CFB) in best visual acuity (BVA) of responders (n = 30) was mean (SD) 12.8 (13.00) letters; CFB in nonresponders (n = 56) was 3.2 (16.3) letters. Sensitivity analyses stratified by initial BVA were supportive. Mean (SD) change in CRT (μm) was -160.4 (111.4) in responders and -62.2 (98.6) in nonresponders. While changes in anti-VEGF therapy were lower in responders versus nonresponders (10.0% vs 23.2%), mean number of injections was similar (8.3 in each cohort).

Conclusion: Despite receiving a substantial number of injections and requiring changes in therapy more frequently, nonresponders showed a lack of clinically meaningful change in BVA and CRT. Nonresponders could be identified after 3 anti-VEGF injections. There remains an unmet need for treatment options in patients with DME who show a nonresponse after 3 months of anti-VEGF treatment.

Keywords: anti-vascular endothelial growth factor; diabetic macular edema; drug therapy; real-world evidence; visual acuity.

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Conflict of interest statement

Financial arrangements of the authors with companies whose products may be related to the present report are listed as declared by the authors: SS has served as a speaker for AbbVie, Bayer, and Novartis, and a consultant for Bayer, Novartis, and Ripple Therapeutics. KK has served as a consultant to Alcon, Allergan (an AbbVie company), Bayer, Novartis, and received a research grant from Bayer. BS-M serves as a consultant for AbbVie and is an employee of Noesis Healthcare Technologies. DM is a consultant for AbbVie and is an employee of Genesis Research. TK, CZ, and AA are full-time employees of AbbVie and may own AbbVie stock/share options. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Patient disposition. *11 eligible patients were excluded from the main cohort (1 patient without baseline central retinal thickness [CRT] measurements within 60 days prior to index, 1 patient without baseline CRT date, and 9 patients received <3 injections of anti-vascular endothelial growth factor during study period).
Figure 3
Figure 3
Percentage of patients requiring alternative therapy at 12, 18 and 24 months. Abbreviation: anti-VEGF, anti-vascular endothelial growth factor.
Figure 4
Figure 4
Change in best visual acuity (BVA) from index date in responders, nonresponders and the overall population at 12, 18 and 24 months from baseline.
Figure 5
Figure 5
Mean change in central retinal thickness (CRT) from baseline in overall cohort, and in responders and nonresponders.
See this image and copyright information in PMC

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