| PICO | Description |
|---|---|
| Population | Adults with diabetic macular edema (DME) confirmed by optical coherence tomography and clinical evaluation. |
| Intervention | Intravitreal aflibercept administered in combination with dexamethasone sodium phosphate. |
| Comparison | Intravitreal aflibercept monotherapy alone. |
| Outcome | The combination treatment led to significant improvements in retinal thickness and visual acuity over the short term. However, it was associated with steroid-related adverse effects, including increased intraocular pressure, requiring monitoring. |
RCT
Arq Bras Oftalmol · 2025
Aflibercept + dexamethasone vs aflibercept for DME
Phase-2 RCT · diabetic macular edema · 3 months
Trial design
Change from baseline — both arms
CMT reduction (combo)
-176 µm
176 ± 129
CMT reduction (mono)
-54 µm
54 ± 49
BCVA gain (combo vs mono)
+0.31 vs -0.06
LogMAR, p=0.020
CMT between-group
p=0.034
favours combo
⬡ Bottom Line
Adding intravitreal dexamethasone to aflibercept produced a significantly greater central macular thickness reduction and visual acuity gain at 3 months, with no significant rise in intraocular pressure. Small phase-2 trial (16 eyes), short follow-up.
P
Population
Adults with diabetic macular edema confirmed on OCT
I
Intervention
Intravitreal aflibercept plus dexamethasone sodium phosphate
C
Comparator
Intravitreal aflibercept monotherapy
O
Outcome
Change in central macular thickness; BCVA and IOP at day 90