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.
Age ≥ 18 years, diagnosis of diabetes mellitus (type Ⅰor type Ⅱ).
With good glycaemic control and glycated haemoglobin ≤10.0%.
DR stage II-IV.
Treatment with aflibercept intravitreal injection is planned for center-involved diabetic macular edema (CI-DME) , Central macular thickness (CMT) ≥300 μm in the 1-mm-diameter zone around fovea with best corrected visual acuity(BCVA) <20/25.
Grade III and IV cataracts, or those with post-comorbid subcapsular cataracts,
Other macular degeneration such as Macular epiretinal membrane and Macular Hole, etc., or macular edema caused by other causes such as uveitis, retinal vein occlusion, etc.,
Combined with diabetic optic neuropathy,
Any prior use of an approved or investigational treatment for DME in the study eye such as anti-VEGF drugs or corticosteroids drugs etc.,
Parallel
Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant
DrugThis group shall receive a combination of Aflibercept Intravitreous Injection (2 mg) and the Dexamethasone Intravitreal Implant (DEX-I, 0.7 mg).
Aflibercept Intravitreous Injection (2mg) Monotherapy
DrugThis 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.
Change in central macular thickness (CMT) of each group 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.
Proportion of eyes with a 10-letter/15-letter BCVA improvement from baseline to month 3, 6, 12.
Change in OCT biomarkers (SRD, HRD, HE, large IRC) from baseline to Month 6 and 12.
Change in the non-perfused area (NPA) of the peripheral retina from baseline to Month 6, 12.
Changes in macular FAZ area by OCTA from baseline to Months 6 and 12.
Changes in macular vessel density by OCTA from baseline to Months 6 and 12.
Change in Diabetic Retinopathy Severity Scale (DRSS) score (recording the proportion of patients with regression ≥1 step and ≥2 steps) from baseline to Months 6 and 12.
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Kun Liu
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor institution
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Peking University People's Hospital
Collaborator
The General Hospital of Central Theater Command
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborator
Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
West China Hospital
Collaborator
The First People's Hospital of Xuzhou
Collaborator
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