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Two-Drug combo may boost vision in diabetic eye disease

NCT ID NCT07438119

Disease control Sponsor: Kun Liu Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a combination of a steroid implant (dexamethasone) plus an anti-VEGF injection (aflibercept) against aflibercept alone for diabetic macular edema. Researchers will enroll 114 people with diabetes who have not had prior treatment. The goal is to see if the combo improves vision and reduces retinal swelling more than the standard single drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone intravitreal implant (steroid) combined with aflibercept injection (anti-VEGF)
What this could lead to
If successful, this combination could offer better vision outcomes for people with diabetic macular edema who have signs of inflammation.
What could go wrong
This is a Phase 4 study that hasn't started yet, with only 114 participants. The combination may not prove superior and carries risks like increased eye pressure or cataract from the steroid.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All of the following conditions must be met simultaneously: 1. Age ≥ 18 years, diagnosis of diabetes mellitus (type Ⅰor type Ⅱ). 2. With good glycaemic control and glycated haemoglobin ≤10.0%. 3. DR stage II-IV. 4. 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. 5. 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). 6. No refractive interstitial clouding and pupillary constriction affecting fundus examination. Exclusion Criteria: 1. Grade III and IV cataracts, or those with post-comorbid subcapsular cataracts, 2. 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., 3. Combined with diabetic optic neuropathy, 4. Any prior use of an approved or investigational treatment for DME in the study eye such as anti-VEGF drugs or corticosteroids drugs etc., 5. History of vitreoretinal surgery and/or including scleral buckling in the study eye, 6. Transscleral fixated IOLs and ruptured posterior lens capsule, 7. Active or suspected ocular and periocular infections, 8. Advanced glaucoma or uncontrolled glaucoma with anti-glaucoma drugs; Or a history of glucocorticoid-induced elevated intraocular pressure, 9. 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, 10. Pregnant or lactating, 11. Patients with hypersensitivity to dexamethasone or to any other components of the product, 12. Patients are allergic to aflibercept or any of the ingredients Aflibercept Intravitreous Injection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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    Open the record ↗

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