Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 12, 2025
Date Accepted: Mar 13, 2026
The remote management in patients with diabetic macular edema receiving long-term intravitreal anti-VEGF therapy (RE-SHINE study): a real-world study protocol
ABSTRACT
Background:
In the real world, patients often fail to comply with intravitreal injections, resulting in treatment outcomes much lower than those observed in clinical trials. RE-SHINE management system builds on existing approaches by integrating behavior change techniques, the remote management system, participatory support, and reminder services to promote sustainable remote management for patients with DME receiving long-term intravitreal anti-VEGF therapy.
Objective:
To describe a remote management program, based on a behavior change wheel model, designed to increase treatment adherence and improve disease outcomes for patients with diabetic macular edema (DME) receiving long-term intravitreal anti-vascular endothelial growth factor (VEGF) therapy.
Methods:
This study proposes a remote management system based on the behavioral change wheel theory to enhance treatment adherence and improve disease prognosis in patients with DME receiving long-term intravitreal anti-VEGF therapy. The study is structured into three phases: theoretical modelling, platform development, and a validation study. A cohort study is used to investigate the effect of the new management model on key metrics, including visual acuity, central retinal thickness, and injection rates.
Results:
The RE-SHINE management has achieved improvements in key metrics, including visual acuity, central retinal thickness, and injection rates, while also enhancing adherence to treatment.
Conclusions:
The RE-SHINE management shifts the project from passive to proactive healthcare management. Clinical Trial: This study was previously registered in Clinicaltrials.gov (Number: ChiCTR2400090348).
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