Diabetic macular edema
Conditions
Interventions
Control group:Anti-VEGF treatment (Aflibercept intravitreal injection solution, 2mg)
Experimental group:Anti-VEGF therapy (Aflibercept intravitreal injection solution, 2 mg) combined with DEX-I (Dexamethasone intravitreal implant, 0.7 mg)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, diagnosed with diabetes (type 1 or type 2); 2. Good blood glucose control and glycated hemoglobin (HbA1c) =300 microns, and best corrected visual acuity (BCVA) =500 microns; large intraretinal cystoid cavity (large IRC) with retinal intraretinal cavity height >=300 microns or width >=250 microns; serous retinal detachment (SRD); hyperreflective dots (HRDs) within the retina; hard exudates (HEs); 6. No refractive media opacity or pupillary constriction affecting fundus examination; 7. After comprehensive evaluation, confirmation of the plan to perform routine abicipar pegol intravitreal injections.
Exclusion criteria
Exclusion criteria: 1. Patients with grade III or IV cataracts, or combined posterior subcapsular cataracts; 2. Presence of other macular lesions (such as epiretinal membrane, macular hole, etc.), or macular edema caused by other reasons (such as uveitis, retinal vein occlusion, etc.); 3. Combined diabetic optic neuropathy; 4. The study eye has previously received any approved or investigational drugs for DME (such as anti-VEGF drugs, corticosteroids, etc.); 5. The study eye has a history of vitreoretinal surgery (including scleral buckling surgery); 6. Aphakic eyes with posterior capsule rupture, intraocular lens fixed via iris or sclera, and eyes with posterior capsule membrane rupture; 7. Presence of active or suspected ocular and periocular infection; 8. Advanced glaucoma, or poorly controlled intraocular pressure after using anti-glaucoma medication, or a history of corticosteroid-induced high intraocular pressure; 9. Uncontrolled systemic diseases (such as asthma, severe hypertension), recent history of cerebrovascular accident or myocardial infarction, or inability to comply with relevant examinations for other reasons; 10. Pregnant or breastfeeding; 11. Allergic to dexamethasone or any component of dexamethasone intravitreal implant; 12. Allergic to aflibercept or any excipient in aflibercept intravitreal injection solution.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in biomarkers (SRD, HRD, HE, large IRC) within 1mm diameter of the fovea at 6 and 12 months in both groups;Change in CMT from baseline at 3 and 12 months in both groups;Safety and tolerability of both regimens, as assessed by the incidence of ocular and systemic adverse events;Changes in BCVA from baseline at 3, 6, and 12 months in both groups;Treatment burden, measured as number of intravitreal injections during the study, in both groups;At 3, 6, and 12 months, the proportion of patients with BCVA improved by 10 letters /15 letters from baseline in both groups; | — |
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in CMT; | — |
Countries
China
Contacts
Public ContactKun Liu
Shanghai General Hospital
Outcome results
None listed