|
Reference | Study name | Follow-up | Type of DME | Type of study | Study methodology | Number of treatments | Mean ETDRS letter gains | Number of eyes |
|
[53] | RIDE | 24 months | CMT OCT ≥ 275 μm | Prospective, multicenter, Phase 3 | Sham | 1.6 laser | 2.3 | 130 |
0.3 mg lucentis | 20.5 IVI; 0.7 laser | 10.9 | 125 |
0.5 mg lucentis | 21.9 IVI; 0.3 laser | 12 | 127 |
Note: rescue laser after month 3 | | | |
|
[53] | RISE | 24 months | CMT OCT ≥ 275 μm | Prospective, multicenter, Phase 3 | Sham | 1.8 laser | 2.6 | 127 |
0.3 mg lucentis | 21.5 IVI; 0.8 laser | 12.5 | 125 |
0.5 mg lucentis | 20.9 IVI; 0.8 laser | 11.9 | 125 |
Note: rescue laser after month 3 | | | |
|
[54] | RESTORE | 12 months | fDME and dDME | Prospective, multicenter, Phase 3 | lucentis + sham laser | 7 IVI | 6.1 | 116 |
Lucentis + laser | 6.8 IVI; 1.7 laser | 5.9 | 118 |
Sham lucentis + laser | 2.1 laser | 0.8 | 111 |
|
[55] | READ-2 | 6 months | CMT OCT ≥ 250 μm | Prospective, multicenter, Phase 2 | Lucentis alone | 4 | 7.2 | 42 |
dDME and fDME | Laser alone | 1.8 | −0.4 | 42 |
| Lucentis + laser | 2 IVI; 2 laser | 3.8 | 42 |
|
[56] | READ-2 | 24 months | CMT OCT ≥ 250 μm | | Lucentis alone | 9.3 | 7.7 | 33 |
Above study [55] + 18 months | dDME and fDME | Prospective, multicenter, Phase 2 | Laser alone; delayed lucentis | 4.4 IVI; 1.8 laser | 5.1 | 34 |
+18 months | | Lucentis + laser | 4.9 IVI; 2 laser | 6.8 | 34 |
|
[57] | RESOLVE | 12 months | CMT OCT ≥ 300 μm | Prospective, multicenter, phase 2 | Lucentis | 10.2 | 10.3 | 102 |
Sham (no medication injected) | 8.9 (sham treatments) | −1.4 | 49 |
Note: rescue laser for both groups | | | |
|
[58] | DA-VINCI | 12 months | CMT OCT ≥ 250 μm | Prospective, multicenter, Phase 2 | Eylea (all arms combined) | 9.3 IVI; 0.7 laser | 9.7 to 13.1 | 175 |
Laser alone | 2.5 | −1.3 | 44 |
Note: rescue laser after month 6 | | | |
|
[59] | DRCR Protocol I: lucentis versus prompt or deferred laser | 36 months | ciDME | Prospective, multicenter | 0.5 mg lucentis + prompt laser | 12 IVI; ≥ 1 laser, 100% | 6.8 | 144 |
0.5 mg lucentis + deferred laser | 15 IVI; ≥ 1 laser, 46% | 9.7 | 147 |
|
[40] | BOLT | 24 months | CMT OCT ≥ 270 μm persistent ciDME | Prospective, single center | Avastin alone | 13 IVI | 8.6 | 37 |
Laser alone | 4 laser | −0.5 | 28 |
|
[41] | PACORS | 24 months | dDME | Retrospective, multicenter | Avastin alone | 5.8 | 11.8 | 141 |
Laser alone | 2.2 | 4.8 | 120 |
Avastin + laser | 6.2 IVI*; 1 laser | 8.2 | 157 |
|