Reference | Phase | Design | Randomized patients (n) | Inclusion | Interventions | Baseline ETDRS score, mean (SD) | Follow-up (months) | Primary outcome | Mean change in BCVA (letters) at Month 12 |
---|---|---|---|---|---|---|---|---|---|
VIVID-DME [13] | III | Randomized, double-blind, multicenter | 136 135 135 | Patients with DME secondary to diabetes mellitus. BCVA ETDRS letter score between 24 and 73 in the study eye | IVT-AFL 2q4* IVT-AFL 2q8* Laser* | 60.8 (10.7) 58.8 (11.2) 60.8 (10.6) | 12 | Mean change in BCVA (ETDRS letters score) at Week 52 | +10.5 +10.7 +1.2 |
VISTA-DME [13] | III | Randomized, double-blind, multicenter | 156 154 156 | Patients with DME secondary to diabetes mellitus. BCVA ETDRS letter score between 24 and 73 in the study eye | IIVT-AFL 2q4* IVT-AFL 2q8* Laser* | 58.9 (10.8) 59.4 (10.9) 59.7 (11.0) | 12 | Mean change in BCVA (ETDRS letters score) at Week 52 | +12.5 +10.7 +0.2 |
IBETA [29] Abstract | III | Randomized, open, single center | 23 21 20 | Clinically significant DME. Snellen logarithm of minimum angle of 20/40 or worse | Laser fixed → PRN IVB 1.5 mg + laser IVTA 4 mg + laser | NR NR NR | 12 | Outcomes included BCVA, OCT-CMT at Week 52 | +9.5 +11.5 +12.5 |
RESTORE [15] | III | Randomized, double-blind, multicenter | 111 116 118 | Focal or diffuse DME. BCVA letter score between 39 and 78 | Laser fixed q4 → PRN* IVR 0.5 mg q4 → PRN* IVR 0.5 mg + laser | 62.4 (11.1) 64.8 (10.1) 63.4 (10.0) | 12 | Mean average change in BCVA from baseline to Month 1 through 12 | +0.8 +6.1 +5.9 |
REVEAL [16] Abstract | III | Randomized, double-blind, multicenter | 133 132 131 | Focal or diffuse DME. BCVA letter score between 39 and 78 | IVR 0.5 mg q4 → PRN* IVR 0.5 mg + laser Laser fixed q4 → PRN* | NR NR NR | 12 | Mean average change in BCVA from baseline to Month 1 through 12 | +6.6 +6.4 +1.8 |
III | Randomized, double-blind, multicenter | 85 43 | DME | IVR 0.5 mg + prompt laser Laser fixed q4 → PRN* | NR NR | 12 | Changes in BCVA, OCT-CRT, and FA | +6.5 +1.4 | |
DRCR.net Protocol I [32] | III | Randomized, double-blind, multicenter | 293 187 188 186 | DME. BCVA letter score between 24 and 78 | Laser fixed q4 → PRN* IVR 0.5 mg + prompt laser IVR 0.5 mg + deferred laser IVTA 4 mg + laser | NR NR NR NR | 12 (maximum 36) | Mean change in BCVA at month 12 | +3 +9 +9 +4 |
DRCR.net Protocol J [33] | III | Randomized, double-blind, multicenter | 123 113 109 | DME and presence of severe NPDR or PDR. ETDRS letter score ≥ 24 | Laser fixed* IVR 0.5 mg + laser IVTA 4 mg + laser | NR NR NR | 12 | Mean change in visual acuity from baseline to Week 14 | −6 −4 −5 |
LUCIDATE [34] Abstract | IV | Randomized, open, single center | 11 11 | DME. BCVA letter score between 55 and 79 | IVR 0.5 mg q4 → PRN Laser fixed → PRN | NR NR | 11 | BCVA ETDRS VA, FA, OCT, microperimetry, full-field and multifocal ERG at Week 48 | +6.0 −0.9 |
Maia et al. (2009) [35] | II/III | Randomized, single-blind, single center | 22 22 | DR and CSME. ETDRS severity level 65 | Laser fixed → PRN IVTA 4 mg + laser | NR NR | 12 | Changes in BCVA, CMT, and TMV | +3** +16** |
PLACID [36] | II | Randomized, double-blind, multicenter | 126 127 | Diffuse DME. BCVA letter score between ≥ 34 and ≤ 70 | Dexamethasone fixed → PRN Laser fixed → PRN* | 57 (9.4) 57.5 (9.5) | 12 | Proportion who gained ≥ 10 letters from baseline to Month 12 | NA |