Summary: In a small phase 2 trial in diabetic macular edema, adding dexamethasone sodium phosphate to intravitreal aflibercept produced greater short-term reduction in macular thickness and better visual acuity than aflibercept alone, with no rise in intraocular pressure in either group.
PICO Summary
| Element | Detail |
|---|---|
| Population | 16 eyes of 16 participants with diabetic macular edema; phase 2 randomised trial, Brazil. |
| Intervention | Intravitreal aflibercept 2 mg plus dexamethasone sodium phosphate 0.04 mg, repeated at 30 and 60 days. |
| Comparison | Intravitreal aflibercept 2 mg monotherapy. |
| Outcome | At day 90, central macular thickness fell more with combination (176 vs 54 µm; p=0.034) and BCVA improved more (+0.31 vs -0.06 LogMAR; p=0.020). Intraocular pressure stable in both groups (p=0.855); none exceeded 21 mmHg or needed pressure-lowering drops. No significant adverse events. |
Aflibercept + dexamethasone for diabetic macular edema
RCT · phase 2 · diabetic macular edema · 90 days
Adding soluble dexamethasone phosphate to aflibercept gave greater short-term macular thickness reduction and visual gain than aflibercept alone, with no IOP rise. Small (16 eyes), 90-day phase 2 signal needing larger confirmation.
Expert Commentary
The rationale is sound, anti-VEGF and corticosteroid hit complementary pathways in diabetic macular edema, and the soluble dexamethasone phosphate used here is a shorter-acting form than the implant, which may explain the reassuring pressure findings. I read the result as promising but preliminary, and I want to correct the earlier write-up on one point: this trial did not show a rise in intraocular pressure with the combination. Pressure was stable in both arms, nobody crossed into ocular hypertension, and no one needed pressure-lowering treatment, so the steroid-IOP caution, while true as a general principle, was not borne out in this study and should not be attributed to it. The overriding limitation is size: sixteen eyes and ninety days is a small, short phase 2 signal, and soluble dexamethasone’s brief duration means the IOP comfort may not extend to longer or repeated steroid exposure. Can I use this with my patients? Not as a directive, and this is an ophthalmology decision in any case. It is encouraging support for combination therapy in eyes responding poorly to anti-VEGF alone, but I would await a larger, longer phase 3 trial before treating it as established.
References
Neri VC, Lira RPC, Vasconcelos AAA, Jorge PHL, Lira GR, Almeida VDCL. Intravitreal aflibercept alone versus combination with dexamethasone phosphate for diabetic macular edema: a randomized phase-2 clinical trial. Arq Bras Oftalmol. 2025;88(5):e20250098. doi:10.5935/0004-2749.2025-0098