# Intravitreal aflibercept alone versus combination with dexamethasone phosphate for diabetic macular edema: A randomized phase-2 clinical trial

## TL;DR

This study compares aflibercept alone versus combined with dexamethasone for diabetic macular edema, finding that the combination improves short-term eye health outcomes.

## Contribution

Demonstrates that combining aflibercept with dexamethasone provides better structural and functional improvements in diabetic macular edema.

## Key findings

- Combination therapy reduced central macular thickness significantly more than aflibercept alone.
- Best-corrected visual acuity improved more in the combination therapy group.
- Intraocular pressure remained stable in both groups with no adverse events.

## Abstract

To compare the short-term (3-month) outcomes of intravitreal aflibercept
injections versus intravitreal aflibercept combined with dexamethasone
sodium phosphate in treating diabetic macular edema.

In this Phase-2 clinical trial, 16 eyes of 16 participants with diabetic
macular edema were randomly assigned to one of 2 groups. Participants in the
aflibercept monotherapy group received 2 mg of intravitreal aflibercept
(0.05 mL), while those in the combination therapy group received 2 mg of
intravitreal aflibercept (0.05 mL) plus 0.04 mg dexamethasone sodium
phosphate (0.01 mL). Identical injections were repeated after 30 and 60
days. The primary outcome was the change in central macular thickness, as
measured by optical coherence tomography, from baseline to 1 month after the
last injection. Secondary outcomes included changes in best-corrected visual
acuity and intraocular pressure over the same period.

The mean baseline central macular thickness was 444 ± 86 µm in
the combination therapy group and 394 ± 96 µm in the
aflibercept monotherapy group (p=0.293). By day 90, the mean reduction in
central macular thickness was significantly greater in the combination
therapy group (176 ± 129 µm) compared to the aflibercept
monotherapy group (54 ± 49 µm; p=0.034). Best-corrected visual
acuity also improved significantly more in the combination therapy group,
with a median gain of 0.31 ± 0.16 LogMAR, whereas the aflibercept
monotherapy group experienced a minimal change (-0.06 ± 0.13 LogMAR;
p=0.020). Intraocular pressure remained stable in both groups, with no
significant difference (p=0.855). None of the participants developed
elevated intraocular pressure (>21 mmHg) or required ocular hypotensive
medications. No significant ocular or systemic adverse events were
reported.

The addition of dexamethasone sodium phosphate to the standard intravitreal
aflibercept regimen for diabetic macular edema can improve short-term
structural and functional outcomes.

Brazilian Clinical Trials Registry (RBR-7468j4q)