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

Sponsor
Kun Liu
Study ID
NCT07438119
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Sep 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Control Group [Anti-VEGF Monotherapy]
    Control Group: Eyes will be administered monthly intravitreal aflibercept during the first 3 months, followed by pro re nata (PRN) regimen from Month 3-12. • Re-treatment criteria: CMT ≥300 μm and/or BCVA decline ≥5 letters from the last-recorded measurement.
  • Experimental: Intervention Group (Combination Therapy with Anti-VEGF and DEX-I)
    Intervention Group: Eyes will be administered monthly intravitreal aflibercept for the first 3 months while the first Dexamethasone Intravitreal Implant (DEX-I) be administered within a 2-week window of the first aflibercept injection. Between Month 3-12, aflibercept and DEX-I will be administered using PRN regimen based on pre-defined re-treatment criteria. * Re-treatment criteria: CMT ≥300 μm and/or BCVA decline ≥5 letters from the last-recorded measurement. * Treatment selection: 1. If the treatment interval since the last DEX-I injection is \<5 months, administer aflibercept alone. 2. If the treatment interval since the last DEX-I injection ≥5 months, administer DEX-I plus aflibercept within a 2-week window.

Primary Outcome Measure

Change in central macular thickness (CMT) of each group from baseline to the end at Month 6. [ Time Frame: From baseline to Month 6. ]

Central Contacts

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