Diabetic Macular Edema (DME)
Conditions
Keywords
DME, aflibercept, dexamethasone implant, Biomarker
Brief summary
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.
Interventions
DRUGCombination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant
This group shall receive a combination of Aflibercept Intravitreous Injection (2 mg) and the Dexamethasone Intravitreal Implant (DEX-I, 0.7 mg).
DRUGAflibercept Intravitreous Injection (2mg) Monotherapy
This group shall be designated to receive Aflibercept Intravitreous Injection at the recommended dose of 2 mg as a standalone treatment. (standard treatment)
Sponsors
Kun Liu
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following conditions must be met simultaneously: 1. Age ≥ 18 years, diagnosis of diabetes mellitus (type Ⅰor type Ⅱ). 2. With good glycaemic control and glycated haemoglobin ≤10.0%. 3. DR stage II-IV. 4. 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. 5. Presence on OCT imaging of one or more of the following findings in the study eye(within 1000-μm-diameter of the center of the fovea): central macular thickness (CMT) ≥500μm, foveal intraretinal cystoid spaces ≥300μm in height or ≥250μm in width(large IRC), serous retinal detachment (SRD), Intraretinal hyperreflective dots (HRDs), Hard exudates (HEs). 6. No refractive interstitial clouding and pupillary constriction affecting fundus examination.
Exclusion criteria
1. Grade III and IV cataracts, or those with post-comorbid subcapsular cataracts, 2. 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., 3. Combined with diabetic optic neuropathy, 4. Any prior use of an approved or investigational treatment for DME in the study eye such as anti-VEGF drugs or corticosteroids drugs etc., 5. History of vitreoretinal surgery and/or including scleral buckling in the study eye, 6. Transscleral fixated IOLs and ruptured posterior lens capsule, 7. Active or suspected ocular and periocular infections, 8. Advanced glaucoma or uncontrolled glaucoma with anti-glaucoma drugs; Or a history of glucocorticoid-induced elevated intraocular pressure, 9. Systemic conditions such as asthma, severe hypertension, cerebrovascular accident or myocardial infarction, or other reasons for not being able to co-operate with the relevant examination, 10. Pregnant or lactating, 11. Patients with hypersensitivity to dexamethasone or to any other components of the product, 12. Patients are allergic to aflibercept or any of the ingredients Aflibercept Intravitreous Injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in central macular thickness (CMT) of each group from baseline to the end at Month 6. | From baseline to Month 6. |
Secondary
| Measure | Time frame |
|---|---|
| Change in central macular thickness (CMT) of each group from baseline to Month 3 and 12. | 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. | 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. | From baseline to month 3, 6, 12. |
| Change in OCT biomarkers (SRD, HRD, HE, large IRC) from baseline to Month 6 and 12. | From baseline to Month 6 and 12. |
| Treatment burden of each group measured as the number of intravitreal injections during the study. | From baseline to Month 12 |
| Safety and tolerability of each group assessed by the incidence of ocular and systemic adverse events. | From baseline to Month 12 |
Contacts
CONTACTKun Liu
Outcome results
None listed