Diffuse diabetic macular edema regimen promising

Dr. Kuppermann presented findings from the 12-month, phase II PLACID study that enrolled patients with diabetes aged 18 or more years with DDME-related retinal thickening, optical coherence tomography-measured central retinal thickness (CRT) ≥275 µm, and best-corrected visual acuity (BCVA) between 34 and 70 letters. He is professor of ophthalmology and biomedical engineering, University of California, Irvine.

Patients were randomly assigned 1:1 to combination therapy of dexamethasone implant plus laser (n = 126) or laser with sham implant (n = 127). Patients received the dexamethasone or sham implant on day 0 and laser photocoagulation 1 month later. Re-treatment with the dexamethasone implant was allowed no earlier than month 6, and up to 3 repeat laser treatments were allowed at intervals of no more than every 3 months.

The percentage of patients with a gain =10 letters in ETDRS BCVA at 12 months was analyzed as the primary efficacy outcome, and there was not a statistically significant difference between the combination and laser alone groups for this endpoint, 28% versus 24%, respectively.

However, in analyses of secondary efficacy outcome variables, there were significant differences favoring the combination dexamethasone implant plus laser group for having a greater percentage of patients with a 10-letter or better gain in BCVA at week 1 and months 1, 4, and 9 (3 months after the second injection); greater mean improvement from baseline BCVA at months 1, 4, 6, 7, and 9; and greater area under the curve for BCVA increase from baseline for the intervals from baseline to month 6 and baseline to month 12.

In addition, reduction in CRT was significantly greater in eyes treated with the combination regimen compared with laser alone at months 1 and 4, and the combination group also showed significantly greater reduction in area of diffuse leakage on fluorescein angiography at months 4, 6, 9, and 12.