PURPOSE

To evaluate the effects of intravitreal dexamethasone (DEX) implants in patients affected by diabetic macular edema (DME) with high best-corrected visual acuity (BCVA) and contraindications to therapy with anti-vascular endothelial growth factor over a 12-month follow-up.

METHODS

In this interventional nonrandomized clinical study, 14 consecutive patients (14 eyes) affected by DME with a BCVA of 0.3 LogMAR or better were prospectively enrolled. All patients were treated with a sustained-release 700-μg DEX implant at baseline, revaluated every 6 weeks, and retreated on a pro re nata basis. Primary outcomes included changes in BCVA and central macular thickness (CMT). Secondary outcomes included number of implants, average period between injections, and incidence of side effects.

RESULTS

At the 12-month examination, a significant improvement in mean BCVA was noted compared to baseline (from 0.25 ± 0.05 to 0.10 ± 0.07 LogMAR; p < 0.001); CMT decreased from 484 ± 127 to 311 ± 51 μm (p < 0.001). No differences in BCVA and CMT improvements were found between treatment- naïve patients and previously treated patients (p = 0.768 and 0.119, respectively). The mean number of implants was 1.71 ± 0.61 (range, 1-3). The mean period between the first and the second implant was 6.1 ± 1.6 months.

CONCLUSIONS

The DEX implant on a pro re nata basis can be considered a beneficial approach for DME patients with high BCVA over a 12-month follow-up; functional and anatomical outcome of the patients significantly improved with few injections and a good safety profile.