|
Reference | Study name | Follow-up | Type of DME | Type of study | Study methodology | Number of treatments | Mean ETDRS letter gains | Number of eyes |
|
[39] | DRCR protocol B: triamcinolone versus laser | 36 months | CMT OCT ≥ 250 μm ciDME | Prospective, multicenter | Laser alone | 3.1 | 5 | 115 |
1 mg triamcinolone | 4.2 IVI | 0 | 93 |
4 mg triamcinolone | 4.1 IVI | 0 | 98 |
|
[43] | Triamcinolone versus placebo for refractory DME | 24 months | ciDME after ≥ 1 previous laser treatment | Prospective, multicenter | Placebo (sham IVI) | N/A | −2.9 | 29 |
4 mg Triamcinolone | 2.6 | 3.1 | 31 |
|
[46] | Flucinolone acetonide |
36 months |
CSME after ≥ 1 previous laser |
Prospective, multicenter, Phase 2 | 0.59 mg flucinolone acetonide surgical implant | 1 | 31% ≥ 15 letter gain | 127 |
Intravitreal implant for DME (Retisert) | Standard of care (observation or laser) | Not stated | 20% ≥ 15 letter gain | 69 |
|
Note: rescue macular laser for both groups | | | |
|
[47] |
**FAME ∧(Iluvien) | 36 months | CMT OCT ≥ 250 μm after ≥ 1 previous laser | Prospective, multicenter | 0.5 μg fluocinolone acetonide intravitreal insert | 1.3 IVI; ≥3 laser in 3.3% | 7.1 | 270 |
0.2 μg fluocinolone acetonide intravitreal insert | 1.2 IVI; ≥3 laser in 6.6% | 8.1 | 276 |
Sham | ≥3 laser in 11.9% | 3.1 | 126 |
Note: rescue macular laser after week 6 | | | |
|
[49] |
***Dexamethasone Drug | 6 months | CSME after ≥ 1 previous laser | Prospective, multicenter, Phase 2 | 700 μg dexamethasone surgical implant | 1 | 33.3% ≥ 10 letter gain∧∧ | 57 |
Delivery system in DME (Ozurdex) | 350 μg dexamethasone surgical implant | 1 | 21.1% ≥ 10 letter gain | 57 |
| Observation | N/A | 12.3% ≥ 10 letter gain | 57 |
|
[50] | Dexamethasone drug Delivery system in vitrectomized patients | 6 months | CMT OCT ≥ 275 μm with history of vitrectomy | Prospective, multicenter, Phase 2 | 0.7 mg dexamethasone IVI | 1 | 3 | 56 |
|