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NCT Number: NCT07438119

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

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.

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Key information

Conditions

Diabetic Macular Edema (DME)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.,
  • History of vitreoretinal surgery and/or including scleral buckling in the study eye,
  • Transscleral fixated IOLs and ruptured posterior lens capsule,
  • 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,
  • Pregnant or lactating,
  • 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.

Treatment and study plan

Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant

Drug

This 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

Drug

This group shall be designated to receive Aflibercept Intravitreous Injection at the recommended dose of 2 mg as a standalone treatment. (standard treatment)

Primary outcomes

  1. Change in central macular thickness (CMT) of each group from baseline to the end at Month 6.

    Time frame: From baseline to Month 6.

Secondary outcomes

  1. Change in central macular thickness (CMT) of each group from baseline to Month 3 and 12.

    Time frame: From baseline to Month 3 and 12.

  2. Change in best corrected visual acuity (BCVA) of each group from baseline to Month 3, 6, and 12.

    Time frame: From baseline to Month 3, 6, and 12.

  3. Proportion of eyes with a 10-letter/15-letter BCVA improvement from baseline to month 3, 6, 12.

    Time frame: From baseline to month 3, 6, 12.

  4. Change in OCT biomarkers (SRD, HRD, HE, large IRC) from baseline to Month 6 and 12.

    Time frame: From baseline to Month 6 and 12.

  5. Treatment burden of each group measured as the number of intravitreal injections during the study.

    Time frame: From baseline to Month 12

  6. Safety and tolerability of each group assessed by the incidence of ocular and systemic adverse events.

    Time frame: From baseline to Month 12

Other outcomes

  1. Change in the non-perfused area (NPA) of the peripheral retina from baseline to Month 6, 12.

    Time frame: From baseline to Month 6, 12.

  2. Changes in macular FAZ area by OCTA from baseline to Months 6 and 12.

    Time frame: From baseline to Month 6, 12

  3. Changes in macular vessel density by OCTA from baseline to Months 6 and 12.

    Time frame: From baseline to Month 6, 12

  4. 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.

    Time frame: From baseline to Month 6, 12

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Liu

CONTACT

[email protected]

+86 18917989522

Sponsors and collaborators

Lead sponsor

Kun Liu

Other

Collaborators

  • Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University
  • First Affiliated Hospital of Fujian Medical University
  • Peking University People's Hospital
  • The First Affiliated Hospital of Dalian Medical University
  • The First People's Hospital of Xuzhou
  • The General Hospital of Central Theater Command
  • The Second Affiliated Hospital of Harbin Medical University
  • West China Hospital
  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Registry information

Official study title

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

Acronym: DECADE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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