Sustained-release corticosteroid implant improves, slows progression of diabetic retinopathy
The FAME program was comprised of 2 identically designed, randomized, double-masked, 3-year trials that enrolled patients who had persistent DME after at least 1 macular laser photocoagulation treatment.
Across the 2 trials, a total of 376 patients were implanted with the 0.19 mg FAc implant that releases 0.2 mcg/day of the corticosteroid, and 185 patients were assigned to the control group, receiving sham injection. Retreatment was allowed beginning at month 12 if patients experienced a ≥ 5-letter loss in best corrected visual acuity (BCVA) or foveal thickness increase ≥ 50 µm from the lowest measure in the previous 12 months.
At enrollment, 60% of patients across the FAc 0.19 mg and sham groups had NPDR, which was graded as moderately severe to severe (levels 47-53).
Assessments of the effect of the FAc intravitreal implant on DR status included analyses of time to first PDR event and of changes in diabetic retinopathy severity scale (DRSS) step according to baseline DRSS level and baseline retinal perfusion status. PDR progression was defined as a change from NPDR to PDR based on review of fundus photographs by masked personnel at the study’s reading center, need for panretinal photocoagulation, or need for pars plana vitrectomy for PDR.
Prolonged time to PDR event
The analyses showed that the mean time to first PDR event was significantly later in the FAc implant group compared to the controls (P < 0.001). Subgroup analyses considering eyes with different DRSS levels at baseline also showed significant prolongation in the time to first PDR event in FAc-treated eyes compared with the controls in eyes with baseline DRSS levels of 47-53 (moderately severe-to-severe NPDR) and 60-75 (mild PDR to high-risk PDR).
In addition, the FAc implant significantly prolonged the time to first PDR event in eyes with and without retinal nonperfusion although the greatest benefit was achieved in the subgroups most at-risk for progression to PDR (i.e., eyes with retinal nonperfusion and those with moderately severe-to-severe NPDR).
Using data from the entire population, numeric differences favoring FAc over sham were also found in analyses of the proportion of patients achieving a ≥ 2-step or ≥ 3-step improvement in DRSS score, although the differences between treatment groups did not achieve statistical significance.
Dr. Campochiaro is a consultant to Alimera Sciences and other companies that market or are developing products for treatment of diabetic eye disease. Dr. Wykoff receives financial support from Alimera Sciences and other companies that market or are developing products for treatment of diabetic eye disease.