NCT07438119Not yet recruitingPhase 4
Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients
Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients (DECADE Study)
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 15 Mar 2026
- Primary completion date
- 15 Sept 2027
- Lead sponsor
- Kun Liu
- Diseases
- Diabetic eye disease
- NCT number
- NCT07438119
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 114
- From 15 Mar 2026 to the primary completion date, 15 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior use of an approved or investigational treatment for DME in the study eye such as anti-VEGF drugs or corticosteroids drugs etc.,
Other illness
- History of vitreoretinal surgery and/or including scleral buckling in the study eye,
- Active or suspected ocular and periocular infections,
- Advanced glaucoma or uncontrolled glaucoma with anti-glaucoma drugs; Or a history of glucocorticoid-induced elevated intraocular pressure,
- 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,
- Patients with hypersensitivity to dexamethasone or to any other components of the product,
- Patients are allergic to aflibercept or any of the ingredients Aflibercept Intravitreous Injection.
Other
- 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,
- Transscleral fixated IOLs and ruptured posterior lens capsule,
- Pregnant or lactating,
Who the study is looking for
- All of the following conditions must be met simultaneously:
- 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.
- 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).
- No refractive interstitial clouding and pupillary constriction affecting fundus examination.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.