Review Article

The Evolving Treatment Options for Diabetic Macular Edema

Table 2

Summary of major studies evaluating corticosteroids for DME.

ReferenceStudy nameFollow-upType of DMEType of studyStudy methodologyNumber of treatmentsMean ETDRS letter gainsNumber of eyes

[39]DRCR protocol B: triamcinolone versus laser36 monthsCMT OCT ≥ 250 μm ciDMEProspective, multicenterLaser alone3.15115
1 mg triamcinolone4.2 IVI093
4 mg triamcinolone4.1 IVI098

[43]Triamcinolone versus placebo for refractory DME24 monthsciDME after ≥ 1 previous laser treatmentProspective, multicenterPlacebo (sham IVI)N/A−2.929
4 mg Triamcinolone2.63.131

[46]Flucinolone acetonide 36 months CSME after ≥ 1 previous laser Prospective, multicenter, Phase 20.59 mg flucinolone acetonide surgical implant131% ≥ 15 letter gain127
Intravitreal implant for DME (Retisert)Standard of care (observation or laser)Not stated20% ≥ 15 letter gain69
Note: rescue macular laser for both groups

[47] **FAME (Iluvien)36 monthsCMT OCT ≥ 250 μm after ≥ 1 previous laserProspective, multicenter0.5 μg fluocinolone acetonide intravitreal insert1.3 IVI; ≥3 laser in 3.3%7.1270
0.2 μg fluocinolone acetonide intravitreal insert1.2 IVI; ≥3 laser in 6.6%8.1276
Sham ≥3 laser in 11.9%3.1126
Note: rescue macular laser after week 6

[49] ***Dexamethasone Drug6 monthsCSME after ≥ 1 previous laserProspective, multicenter, Phase 2700 μg dexamethasone surgical implant133.3% ≥ 10 letter gain57
Delivery system in DME (Ozurdex)350 μg dexamethasone surgical implant121.1% ≥ 10 letter gain57
ObservationN/A12.3% ≥ 10 letter gain57

[50]Dexamethasone drug
Delivery system in vitrectomized patients
6 monthsCMT OCT ≥ 275 μm with history of vitrectomyProspective, multicenter, Phase 20.7 mg dexamethasone IVI1356

*IVI: intravitreal injection.
**Specific number of laser treatments not stated.
***Specific letter gains not stated.
Trade name of medication used is indicated in parentheses ().
Primary endpoint was day 90 and 10 letter gain.