Home Monitoring of Visual Acuity and OCT Versus Hospital Care for Diabetic Macular Edema A Randomized Clinical Trial Evaluating Anti-VEGF Treatment Follow-Up

What this Trial Is About

Diabetic macular edema (DME) is a leading cause of central vision loss in people with diabetes and poses a significant global health challenge. Many patients with DME require frequent anti-VEGF drug treatments and monitoring visits including visual acuity tests and optical coherence tomography (OCT) scans to decide if further treatment is needed. These frequent hospital visits, often monthly or every two months, place a heavy burden on both patients and eye clinics. New portable devices have been created that allow patients to perform OCT scans at home, but these devices do not currently include visual acuity testing. This research aims to evaluate a new home monitoring approach that combines home OCT and visual acuity testing to reduce hospital visits without compromising vision outcomes in DME patients receiving anti-VEGF treatment. Participants will first receive five anti-VEGF injections spaced every four weeks during a loading phase. After this, participants who complete the loading phase are randomly assigned to either a home-based care group or a standard hospital/clinic-based care group. The home care group will perform self-administered visual acuity tests and OCT scans at home every four weeks up to 48 weeks and then as needed, with results transmitted to their clinician and online consultations arranged. The hospital care group will continue standard in-clinic visual acuity and OCT assessments on the same schedule. Both groups will receive additional anti-VEGF injections as needed according to the study protocol. Laser treatment may be given if clinically necessary, but not within the first six months for high-risk cases. During the 96-week trial, participants will be closely monitored with visual acuity exams and OCT imaging to track changes in vision and retinal thickness. Researchers will measure the primary outcome of change in best-corrected visual acuity from randomization to 96 weeks. Clinic visit frequency, treatment adherence, and safety will also be monitored. The study aims to show that home-based monitoring does not lead to worse vision outcomes compared to standard hospital care, while potentially reducing the burden of frequent visits for patients and clinics.

Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT