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.
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
- Are there results?
- Not yet: the study is under way
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,
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- 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.
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.
- Conditions
- Diabetic Macular Edema (DME)
- 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 group | Role | What they receive |
|---|---|---|
| Control Group [Anti-VEGF Monotherapy] | Other | 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. Receives: Drug: Aflibercept Intravitreous Injection (2mg) Monotherapy |
| Intervention Group (Combination Therapy with Anti-VEGF and DEX-I) | Experimental | 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. 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.
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)
Change in central macular thickness (CMT) of each group from baseline to Month 3 and 12.
Measured: From baseline to Month 3 and 12.
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.
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.
Change in OCT biomarkers (SRD, HRD, HE, large IRC) from baseline to Month 6 and 12.
Measured: From baseline to Month 6 and 12.
Treatment burden of each group measured as the number of intravitreal injections during the study.
Measured: From baseline to Month 12
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.
- First posted27 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kun Liu
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Peking University People's Hospital, The General Hospital of Central Theater Command, First Affiliated Hospital of Fujian Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University, Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University, The First Affiliated Hospital of Dalian Medical University, West China Hospital, The First People's Hospital of Xuzhou
- Responsible party
- Sponsor-investigator, Kun Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients (DECADE Study)
- ClinicalTrials.gov ID
- NCT07438119
- Acronym / sponsor ID
- DECADE / 2025HS276
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- DME, aflibercept, dexamethasone implant, Biomarker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Kun LiuUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, Peking University People's Hospital, The General Hospital of Central Theater Command, First Affiliated Hospital of Fujian Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University, Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University, The First Affiliated Hospital of Dalian Medical University, West China Hospital, The First People's Hospital of Xuzhou
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group [Anti-VEGF Monotherapy] | Other | Drug: Aflibercept Intravitreous Injection (2mg) MonotherapyControl 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. |
| Intervention Group (Combination Therapy with Anti-VEGF and DEX-I) | Experimental | Drug: Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal ImplantIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Therapy with Aflibercept Intravitreous Injection (2mg) and Dexamethasone Intravitreal ImplantThis group shall receive a combination of Aflibercept Intravitreous Injection (2 mg) and the Dexamethasone Intravitreal Implant (DEX-I, 0.7 mg). | Drug | Intervention Group (Combination Therapy with Anti-VEGF and DEX-I) |
| Aflibercept Intravitreous Injection (2mg) MonotherapyThis group shall be designated to receive Aflibercept Intravitreous Injection at the recommended dose of 2 mg as a standalone treatment. (standard treatment) | Drug | Control Group [Anti-VEGF Monotherapy] |
Primary outcome
Change in central macular thickness (CMT) of each group from baseline to the end at Month 6.
Time frame: From baseline to Month 6.
6 secondary outcomes
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.
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.
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.
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.
Treatment burden of each group measured as the number of intravitreal injections during the study.
Time frame: From baseline to Month 12
Safety and tolerability of each group assessed by the incidence of ocular and systemic adverse events.
Time frame: From baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Liu (+86 18917989522, drliukun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.