Table 1.
Agent | Total Dose (Daily Release) |
Formulation | Procedure | Duration of Action of 1 Injection | Primary Endpoint | Number of Treatments Over 36 Months in RCTs | Number of Treatments Over 12 Months in Real Life | Licensed DME Indication | Reference(s) |
---|---|---|---|---|---|---|---|---|---|
DEX | 700 μg (~6.25 μg/day) OZURDEX® |
Biodegradable | Injectable 22 gauge needle/stepped incision | ~4 months | % ≥15 letter gain in BCVA at year 3; 22% vs 12%; p<0.001 (OZURDEX vs sham group) | 5.0 | N/A | Adult patients with visual impairment due to DME who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for, non-corticosteroid therapy | [11,57] |
Systematic review of real-life studies | N/A | 2.6 | [13] | ||||||
IVTA | 4 mg TA (unknown) | Preservative-free | Injectable 25 gauge needle/standard intravitreal injection | ~3 months | 3-year extension: mean BVCA = +5 with laser vs +0 with TA | 4.1 | N/A | Not licenced in the EU | [96] |
FAc | 190 μg (0.2 μg/day) ILUVIEN® | Nonbioerodible (polyimide tube) | Injectable 25 gauge needle/standard intravitreal injection | Up to 3 years | ≥15 letter gain (chronic DME) 34% vs 13%; p<0.001 (ILUVIEN vs sham group) | 1.3 | 1 | Vision impairment associated with chronic DME considered insufficiently responsive to available therapies | [7,70] |
Notes: Adapted from Kane et al, 2008.66
Abbreviations: BCVA, best corrected visual acuity; DEX, dexamethasone; DME, diabetic macular edema; FAc, fluocinolone acetonide; IVTA, intravitreal triamcinolone acetonide; N/A, not applicable; RCT, randomized controlled trial; TA, triamcinolone acetonide.