Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients

This is a 12-month, prospective, randomized controlled, multi-center, open-label, superiority designed study. Treatment-Naïve DME patient with inflammatory biomarkers, who meet the inclusion and exclusion criteria, will be recruited. This study aims to provide the first direct comparative evidence within a Chinese cohort, evaluating the efficacy and safety of a combined DEX-I plus aflibercept therapy versus aflibercept monotherapy for DME. The investigation will focus on functional visual outcomes, anatomical improvements, and the respective safety profiles associated with each treatment regimen. Furthermore, the study will incorporate specific optical coherence tomography (OCT) biomarkers to refine patient selection, with the goal of enhancing the precision of identifying candidates for combination therapy. It is hypothesized that the combination therapy, by concurrently targeting both VEGF-mediated and inflammatory pathways, may yield superior clinical outcomes compared to monotherapy.

NCT Number	NCT07438119
Lead Sponsor	Kun Liu Collaborators: The Second Affiliated Hospital of Harbin Medical University, Peking University People's Hospital, The General Hospital of Central Theater Command, First Affiliated Hospital of Fujian Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University, Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University, The First Affiliated Hospital of Dalian Medical University, West China Hospital, The First People's Hospital of Xuzhou
Conditions	Diabetic Macular Edema (DME)
Enrollment	114 participants
Start Date	2026-03-15
Primary Completion	2027-09-15 (estimated)
Study Completion	2028-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-02-27