Table 1.

Summary of main clinical trials with DEX intravitreal implant for the treatment of diabetic macular edema

Study	Phase	Number of eyes	Follow-up (months)	Treatment arms	Outcome measures	Results
Haller et al74	II	171	6	0.35 mg DEX implant vs 0.7 mg DEX implant vs observation	Percentage of patients gaining ≥ letters in BCVA from baseline at day 90	0.7 mg DEX implant (33.3%), and 0.35 mg DEX implant (21.1%) greater than observation (12.3%); P=0.007
					CRT decreases from baseline at day 90 Percentage of patients with ≥2 levels decrease in fluorescein leakage at day 90	−132.3 µm (0.7 mg) vs −30.2 µm; (observation) P<0.001 36.4% (0.7 mg) vs 5.4% (observation); P<0.001
Boyer et al81	II	55	6	0.7 mg DEX implant (vitrectomized patients)	BCVA increase from baseline at month 6 Percentage of patients gaining a ≥ letters in BCVA from baseline	Mean +3.0 letters; P=0.046 21% at month 6
					CRT change from baseline at month 6 Percentage of patients with fluorescein leakage in the macula	Mean −38.9 µm at month 6; P=0.004 96.4% at baseline vs 84.0% at month 6
Callanan et al78	II	253	12	0.7 mg DEX implant + laser vs laser	Percentage of patients gaining ≥ 10 letters in BCVA from baseline at month 12	27.8% (0.7 mg DEX implant + laser) vs 23.6% (laser); P=0.453
					BCVA change from baseline	Greater improvement in DEX implant + laser than laser alone, in patients with diffuse DME over 12 months (AUC analysis); P<0.001
					CRT change from baseline	No significant difference between arms in mean CRT change from baseline at month 12
					Fluorescein leakage area from baseline	Mean change in leakage area decreased greater in DEX implant + laser than laser alone, in all time points; P≤0.041
Gillies et al79	II	88	12	0.7 mg DEX implant vs 1.25 mg bevacizumab	Percentage of patients gaining ≥ 10 letters in BCVA from baseline at month 12	41% (DEX implant) vs 40% (bevacizumab); P=0.99
					Mean improvement in BCVA	+5.6 letters (DEX implant) vs +8.9 letters (bevacizumab); P=0.24
					CRT change from baseline	Mean −187 µm (DEX implant) vs −122 µm (bevacizumab); P=0.015
Boyer et al76	III	1,048	36	0.35 mg DEX implant vs 0.7 mg DEX implant vs sham	Percentage of patients gaining ≥ 15 letters in BCVA from baseline at month 36	0.7 mg DEX implant (22.2%), and 0.35 mg DEX implant (18.4%) greater than sham (12%); P≤0.018
					CRT decrease from baseline	Mean decrease in CRT with 0.7 mg DEX implant (−111.6 µm), and 0.35 mg DEX implant
						(−107.9 µm) greater than sham (−41.9 µm); P<0.001 (AUC analysis)

Abbreviations: AUC, area under the curve; BCVA, best corrected visual acuity; CRT, central retinal thickness; DDS, drug delivery system; DEX, dexamethasone.