Two-Drug combo may boost vision in diabetic eye disease
NCT ID NCT07438119
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- High-Dose eye injection tested against stubborn diabetic swelling
- One eye injection, four targets: GenSci148 tested against retinal swelling
- Can one shot in the eye treat diabetic macular edema?
- Could a pill replace eye injections for diabetic vision loss?
- Can a new eye injection beat the current standard for diabetic vision loss?
- AI could predict which eye treatments work best for Diabetes-Related vision loss