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Diabetic Macular Edema (DME)Phase 4DECADENCT07438119

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

A Phase 4 study testing Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant and Aflibercept Intravitreous Injection (2mg) Monotherapy in people with Diabetic Macular Edema (DME), run by Kun Liu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant and Aflibercept Intravitreous Injection (2mg) Monotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
No sites listed yet
Study dates
15 Mar 2026to 15 Mar 2028
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 12Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kun Liu contact

+86 18917989522

drliukun@sjtu.edu.cn

About this study

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

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.

Being tested
Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant, Aflibercept Intravitreous Injection (2mg) Monotherapy
Keywords
DME, aflibercept, dexamethasone implant, Biomarker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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) MonotherapyDrug

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

Study groups in NCT07438119
Study groupRoleWhat they receive
Control Group [Anti-VEGF Monotherapy]OtherControl 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.
Receives: Drug: Aflibercept Intravitreous Injection (2mg) Monotherapy
Intervention Group (Combination Therapy with Anti-VEGF and DEX-I)ExperimentalIntervention 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.
Receives: Drug: Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to Month 6.

Secondary outcomes (6)

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

    Measured: 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.

    Measured: 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.

    Measured: From baseline to month 3, 6, 12.

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

    Measured: From baseline to Month 6 and 12.

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

    Measured: From baseline to Month 12

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

    Measured: From baseline to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion15 Sep 2027 (estimated)
  4. Study completion15 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07438119
Sponsor's protocol ID
2025HS276
Acronym
DECADE
Status last verified
Feb 2026
First submitted
6 Feb 2026
Last updated
27 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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