Table 2.

Endpoints and results among fluocinolone device studies for the treatment of diabetic macular edema

Author	Eyes	Endpoints	Results
FAc implant
Bausch and Lomb55	80 eyes (1:1 to 0.5 mg FAc or SOC)	Retinal thickening after 6 mo	FAc significantly better (P = 0.03)
		Improvement in severity of DR after 6 mo	FAc significantly better (P = 0.01)
		Improvement or stable VA after 6 mo	80% in treatment group vs 50% in SOC (P < 0.01)
Pearson et al57	197 eyes (2:1 to 0.59 mg FAc or SOC)	Visual acuity gain of ≥three lines	28% in FAc vs 15% in SOC at 3 yrs (P < 0.05)
		Visual acuity loss of ≥three lines	19% in FAc vs 16% in SOC at 3 yrs (NS)
		Resolution of edema at center of macula	58% in FAc vs 30% SOC at 3 yrs (P < 0.001)
		Improvement in diabetic retinopathy scores	13% in FAc vs 4% SOC at 3 yrs (P < 0.001)
Pearson et al56	196 eyes (2:1 0.59 mg FAc or SOC)	Visual acuity gain of ≥15 letters	FAc significantly better until 1 yr
		Improvement in macular edema	FAc significantly better until 2 yrs
		ETDRS diabetic retinopathy severity scale	FAc improved faster, declined slower
		Leakage by FA	FAc significantly better until 2 yrs
		Maximum cystoid score	FAc significantly better until 1 yr
FAc insert
Campochiaro et al58	37 eyes (2:1 0.2 μg/day, 0.59 μg/day)	Change in BCVA at month 12	1.3 letters (low dose), 5.7 letters (high dose)
Campochiaro et al60	956 eyes (2:2:1 0.2 μg/day, 0.5 μg/day, or sham)	≥15-letter increase in VA	FAc group better through 3 years
		Mean improvement VA from baseline	FAc groups better through 3 years
		Decreased retinal thickness	FAc groups better through 2 years

Abbreviations: BCVA, best-corrected visual acuity; DR, diabetic retinopathy; ETDRS, Early Treatment Diabetic Retinopathy Study; FA, fluorescein angiography; FAc, fluocinolone acetonide; SOC, standard of care; VA, visual acuity; NS, not significant.