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

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.

Conditions

• Diabetic Macular Edema (DME)

Interventions

DRUG

Combination 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).

DRUG

Aflibercept 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 & Collaborators

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• The General Hospital of Central Theater Command

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Zhongshan Ophthalmic Center, Sun Yat-sen University

  collaborator OTHER

• Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First People's Hospital of Xuzhou

  collaborator OTHER

• Kun Liu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2027-09-15

Completion

2028-03-15