Table 1.
Published studies on the use of DEX implant for age-related macular degeneration
| Reference | Study design | No of eyes | Previous treatment | Treatment | Follow-up | Retreatment | BCVA | CMT | Complications |
|---|---|---|---|---|---|---|---|---|---|
| Calvo et al22 | Retrospective | 7 refractory | 3 anti-VEGF | 1 DEX + ranibizumab monthly | 6 months | 2 DEX (28.5%) | From 0.53±0.13 logMAR to 3 months: 0.45±0.3 (P=0.23) 6 months: 0.52±0.2 (P=0.23) |
From 273.14±50.94 μm to 3 months: 241.5±36.6 μm; (P=0.04) 6 months: 260.71±58.51 μm (P=0.40) |
3 ocular hypertension (42.8%) (27–32 mmHg) |
| Kuppermann et al 23 | Prospective multicenter randomized | 243 | 115 naïve: | 58 DEX + ranibizumab vs 57 sham + ranibizumab PRN | 6 months | 3.15 DEX + ranibizumab PRN | Naïve Change from baseline: DEX: +0.3 to +2.7 L Sham: −0.5 to +2.6 L |
Naïve Change from baseline: DEX: −12.61±96.4 μm Sham: −34.70±106.6 μm (P<0.05) |
DEX 18.2% IOP ≥25 mmHg |
| 128 prev treatment | 65 DEX + ranibizumab vs 63 sham + ranibizumab PRN | 3.37 sham + ranibizumab | Prev treatment Change from baseline: DEX: +0.4 to +2.4 L Sham: −0.3 to 2.6 L |
Prev treatment Change from baseline: DEX:−1.74±54.4 μm Sham:+6.84±84.9 μm (P=ns) |
Sham 5.1% IOP ≥25 mmHg (P=0.002) |
||||
| Rezar-Dreindl et al24 | Prospective randomized | 40 | 5.6±3.4 ranibizumab | 20 ranibizumab | 12 months | 7.95 ranibizumab P=0.042 |
From 62 to 68 L (P=0.2) |
From 485 μm to 6 months: 426 μm 12 months: 453 μm (P=0.38) |
9% cataract surgery 0% IOP >30 mmHg 33% cataract surgery |
| 6.7±4.4 ranibizumab | 20 ranibizumab + DEX | 5.5 ranibizumab + 2 DEX (18 eyes) | 68 to 71 L | From 439 μm to 6 months: 375 μm 12 months: 368 μm |
15% IOP >30 mmHg | ||||
| Chaudhary et al25 | Prospective multicenter randomized | 10 | NR | 5 ranibizumab | 6 months | 6.2±2.3 | Change from baseline: 10.8±13.2 L 3.0±10.5 L (P=0.331) |
Change from baseline: 31.7%±17.5% to 13.3%±27.0% (P=0.236) |
1 IOP >30 mmHg |
| 5 ranibizumab + DEX | 5.8±1.8 (P=0.766) |
Abbreviations: BCVA, best corrected visual acuity; CMT, central macular thickness; DEX, dexamethasone implant; IOP, intraocular pressure; Naïve, previously untreated; NR, not reported; ns, not significant; prev treatment, previously treated; PRN, pro re nata; VEGF, vascular endothelial growth factor.