Table 3.
Overview of the functional and anatomic results of ranibizumab.
| Study | Ref. | Duration (w) | Regimen | N (eyes) | BCVA (ETDRS letters) | CRT (µm) | ||
|---|---|---|---|---|---|---|---|---|
| Baseline | Change | Baseline | Change | |||||
| READ-2 | [43] | 24 | Rani | 42 | 24.85 | 7.24∗∗ | 422 | −106.3 |
| Rani + laser | 42 | 24.87 | 3.8 | 474.5 | −117.2 | |||
| Laser | 42 | 28.35 | −0.43 | 439.6 | −82.8 | |||
|
| ||||||||
| RESOLVE | [44] | 52 | Rani | 102 | 60.2 (9.9) | 7.8 (7.7)∗∗ | 455.4 (114.2) | −194.2 (135.1)∗∗ |
| Sham | 49 | 61.1 (9.0) | −0.1 (9.8) | 448.9 (102.8) | −48.4 (153.4) | |||
|
| ||||||||
| RESTORE | [45] | 52 | Rani + sham | 116 | N.A. | 6.1 (6.3)∗∗ | N.A. | −118.7 (115.1)∗∗ |
| Rani + laser | 118 | N.A. | 5.9 (7.9)∗∗ | N.A. | −128.3 (114.3)∗∗ | |||
| Laser + sham | 111 | N.A. | 0.8 (8.6) | N.A. | −61.3 (132.3) | |||
|
| ||||||||
| RESTORE Ext. | [55] | 156 | Rani + sham | 116 | N.A. | 8.0 (1.1) | 116 | −142.1 |
| Rani + laser | 118 | N.A. | 6.7 (1.1) | 118 | −145.9 | |||
| Laser + sham | 111 | N.A. | 6.0 (1.1) | 111 | −142.7 | |||
|
| ||||||||
| DRCR.net | [47] | 56 | Rani 0.5 | 113 | 68 (56–−75) | +2 (−3 to +7)∗∗ | 352 (283–−476) | −26 (−92 to +15)∗ |
| Triam | 109 | 67 (59–−75) | +1 (−3 to +8)∗∗ | 359 (271–−472) | −75 (−168 to −17)∗∗ | |||
| Sham | 123 | 67 (52–−75) | −2 (−8 to +3) | 355 (285–−510) | 0 (−80 to +70) | |||
|
| ||||||||
| RISE | [46] | 104 | Rani 0.3 mg | 125 | 54.7 (12.6) | 12.5∗∗∗ | 4745. (174.8) | −250.6∗∗∗ |
| Rani 0.5 mg | 125 | 56.9 (11.6) | 11.9∗∗∗ | 463.8 (144.0) | −253.1∗∗∗ | |||
| Sham | 127 | 57.2 (11.1) | 2.6 | 467.3 (152.0) | −133.4 | |||
|
| ||||||||
| RIDE | [46] | 104 | Rani 0.3 mg | 125 | 57.5 (11.6) | 10.9∗∗∗ | 482.6 (149.3) | −259.8∗∗∗ |
| Rani 0.5 mg | 127 | 56.9 (11.8) | 12.0∗∗∗ | 463.8 (175.5) | −270.7∗∗∗ | |||
| Sham | 130 | 57.3 (11.2) | 2.3 | 447.4 (154.4) | −125.8 | |||
|
| ||||||||
| RISE | [49] | 156 | Rani 0.3 mg | 125 | 54.7 (12.6) | 14.2 (12.8)∗∗∗ | 4745. (174.8) | −261.2 (196.5) |
| Rani 0.5 mg | 125 | 56.9 (11.6) | 11.0 (12.9)∗∗∗ | 463.8 (144.0) | −269.1 (178.9) | |||
| Sham | 127 | 57.2 (11.1) | 4.3 (14.9) | 467.3 (152.0) | −200.1 (215.6) | |||
|
| ||||||||
| RIDE | [49] | 156 | Rani 0.3 mg | 125 | 57.5 (11.6) | 10.6 (12.9)∗∗∗ | 482.6 (149.3) | −261.8 (180.8) |
| Rani 0.5 mg | 127 | 56.9 (11.8) | 11.4 (16.3)∗∗∗ | 463.8 (175.5) | −266.7 (207.8) | |||
| Sham | 130 | 57.3 (11.2) | 4.7 (13.3) | 447.4 (154.4) | −213.2 (193.5) | |||
|
| ||||||||
| RISE | [57] | 208 | Rani 0.3 mg | 89 | 54.4 (12.0) | −1.7 (−3.6 to 0.2) | 475.9 (170.2) | 23.3 (−7.7 to 54.3) |
| Rani 0.5 mg | 79 | 56.5 (10.9) | 0.8 (−1.1 to 2.7 | 476.7 (139.5) | 4.2 (−17.1 to 25.4) | |||
| Sham | 77 | 57.8 (10.5) | 1.3 (−0.3 to 2.9) | 462.8 (141.4) | 29.6 (3.4–55.7) | |||
|
| ||||||||
| RIDE | [57] | 208 | Rani 0.3 mg | 83 | 58.3 (11.3) | −0.9 (−3.6 to 1.8) | 480.3 (186.9) | 46.1 (−2.6 to 94.8 |
| Rani 0.5 mg | 84 | 56.9 (11.8) | 0.6 (−1.2 to 2.4 | 481.1 (163.2) | 44.1 (16.1–72.1) | |||
| Sham | 88 | 57.8 (11.4) | −2.6 (−5.6 to 0.5) | 441.3 (146.3) | 9.6 (−18.4 to 37.6) | |||
|
| ||||||||
| REFINE | [64] | 52 | Rani 0.5 mg | 307 | 59.6 (10.5) | 7.8 (0.7)∗∗ | 473.4 (166.1) | −146.5 (157.6)∗∗ |
| Laser | 77 | 58.2 (9.4) | 2.5 (7.8) | 475.0 (161.5) | −85.9 (166.6) | |||
Note. READ-2: measured subfoveal thickness. RESOLVE: ranibizumab group included intravitreal injections of 0.3 mg and 0.5 mg (51 eyes each). DRCR.net: patients received laser besides their treatment assigned; measured central subfield thickness; differences were calculated at week 14 (primary outcome of the study). RESTORE extension: all patients enrolled in the extension study were eligible to receive intravitreal ranibizumab 0.5 mg injections (subgroups were maintained for evaluating the effect of ranibizumab according to the initial treatment). ∗p < 0.01 vs. reference comparator (laser, sham, triamcinolone, etc.). ∗∗p < 0.001 vs. reference comparator (laser, sham, triamcinolone, etc.). ∗∗∗p < 0.0001 vs. reference comparator (laser, sham, triamcinolone, etc.). w: weeks; BCVA: best-corrected visual acuity; EDTRS: Early Treatment of Diabetic Retinopathy Study; CRT: central retina thickness; DRCR.net: Diabetic Retinopathy Clinical Research Network; Rani: ranibizumab; Triam: triamcinolone acetonide.