Remote Management of Patients With Diabetic Macular Edema Receiving Long-Term Intravitreal Anti-Vascular Endothelial Growth Factor Therapy (RE-SHINE Study): Protocol for a Real-World Study.

Background: Long-term intravitreal anti-vascular endothelial growth factor therapy is the gold standard for treating diabetic macular edema (DME). However, poor treatment adherence in real-world settings often leads to suboptimal visual outcomes. Evidence-based remote management strategies are required to bridge the gap between clinical protocols and patient self-management. Objective: This study aims to describe a remote management program based on the Behavior Change Wheel model designed to increase treatment adherence and improve disease outcomes for patients with DME receiving long-term anti-vascular endothelial growth factor therapy, and to report the study protocol. Methods: The RE-SHINE study was structured into three phases: theoretical modeling, digital platform development, and a validation cohort study. The intervention included a smartphone-based app providing personalized health education, self-monitoring of vision (Amsler grid), injection reminders, and direct communication with health care providers. The efficacy of the remote management model was tested in a real-world cohort study. Participants were assessed at baseline and at each follow-up visit over 12 months. The primary outcome measure was best-corrected visual acuity, and secondary outcome measures included central retinal thickness and treatment adherence (injection rate and follow-up frequency). Results: A total of 1006 patients with DME underwent initial screening, and 958 (95.2%) patients met the inclusion criteria, with only 7 patients declining follow-up. We anticipate that the remote management system will be both feasible and acceptable for patients with DME. It is hypothesized that the intervention group would demonstrate significantly higher levels of treatment adherence and better visual preservation compared to the retrospective control group. In addition, we intend to assess the impact of the digital intervention on patient-reported outcomes, encompassing quality of life and self-efficacy. Participant recruitment began in September 2023 and was completed by the time of submission. The data analysis is yet to begin. The results are expected to be published in 2026. Conclusions: A Behavior Change Wheel-based remote management approach could be a scalable and sustainable method to enhance adherence in patients requiring long-term intravitreal therapy. If proven effective, this model could be integrated into routine ophthalmic care to mitigate the risk of vision loss due to undertreatment in DME.