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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
This group shall receive a combination of Aflibercept Intravitreous Injection (2 mg) and the Dexamethasone Intravitreal Implant (DEX-I, 0.7 mg).
This group shall be designated to receive Aflibercept Intravitreous Injection at the recommended dose of 2 mg as a standalone treatment. (standard treatment)
Change in central macular thickness (CMT) of each group from baseline to the end at Month 6.
Time frame: From baseline to Month 6.
Change in central macular thickness (CMT) of each group from baseline to Month 3 and 12.
Time frame: From baseline to Month 3 and 12.
Change in best corrected visual acuity (BCVA) of each group from baseline to Month 3, 6, and 12.
Time frame: From baseline to Month 3, 6, and 12.
Proportion of eyes with a 10-letter/15-letter BCVA improvement from baseline to month 3, 6, 12.
Time frame: From baseline to month 3, 6, 12.
Change in OCT biomarkers (SRD, HRD, HE, large IRC) from baseline to Month 6 and 12.
Time frame: From baseline to Month 6 and 12.
Treatment burden of each group measured as the number of intravitreal injections during the study.
Time frame: From baseline to Month 12
Safety and tolerability of each group assessed by the incidence of ocular and systemic adverse events.
Time frame: From baseline to Month 12
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