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Clinical outcomes of a treat and extend regimen with intravitreal aflibercept injections in patients with diabetic macular edema: Experience in clinical practice
Curry, BA and Sanfilippo, PG and Chan, S and Hewitt, AW and Verma, N, Clinical outcomes of a treat and extend regimen with intravitreal aflibercept injections in patients with diabetic macular edema: Experience in clinical practice, Ophthalmology and Therapy, 9, (1) pp. 87-101. ISSN 2193-8245 (2020) [Refereed Article]
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Introduction: Treat-and-extend (T&E) and pro re nata (PRN; ‘as needed’) regimens of intravitreal anti-vascular endothelial growth factor (VEGF) treatment have been found to reduce the injection burden on patients and improve the cost effectiveness of the treatment of macular edema. The aim of this study was to assess the effectiveness of a T&E regimen of aflibercept, in a clinical setting, in patients with diabetic macular edema (DME) who were either intravitreal anti-VEGF therapy naive or with minimal exposure to anti-VEGF (B 6 treatments) in the previous 12 months.
Methods: This prospective, single arm, open label study recruited patients with DME (macular thickness of C 300 lm) and best-corrected visual acuity (BCVA) between 28-78 ETDRS letters. Participants received five loading doses of intravitreal aflibercept at 4-weekly intervals. BCVA measurements and macular optical coherence tomography were performed at each visit. If no disease activity was detected, treatment intervals were increased by 2 weeks to a maximum of 12 weeks. Outcome measures included: changes in BCVA and retinal anatomical measures (central foveal thickness [CFT] and central macular volume within 6 mm of the fovea [CSVol]) between baseline and 2 years, patient treatment intervals; and adverse events.
Results: Of the 36 patients who provided informed consent to participate in the study and were screened, 26 patients (eyes) were eligible to participate in the study. After regression analysis, adjustment for repeated measures, and significant covariates, the mean BCVA increased by 3.8 letters (95% confidence interval [CI] 1.1, 6.4) and the CFT and CSVol decreased by 127.2 lm (95% CI 91.7, 162.5) and 1.6 mm3 (95% CI 1.2, 2.0), respectively, over the course of the study. In the second year, 16 of the 25 patients still participating had their treatment intervals extended to 12 weeks. There was no evidence of any new adverse events that would require changes to the aflibercept safety profile.
Conclusion: For the majority of patients presenting with DME, a T&E regimen of aflibercept in the first 2 years of therapy is a practical alternative to PRN treatment with regular review.
|Item Type:||Refereed Article|
|Keywords:||aflibercept, anti-vascular endothelial growth factor, clinical setting, diabetic macular oedema, treat and extend|
|Research Division:||Biomedical and Clinical Sciences|
|Research Group:||Ophthalmology and optometry|
|Objective Division:||Expanding Knowledge|
|Objective Group:||Expanding knowledge|
|Objective Field:||Expanding knowledge in the health sciences|
|UTAS Author:||Hewitt, AW (Professor Alex Hewitt)|
|UTAS Author:||Verma, N (Dr Nitin Verma)|
|Web of Science® Times Cited:||17|
|Downloads:||21 View Download Statistics|
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