Study design | MARINA (N = 716)13 | ANCHOR (N = 423)12 24 | PIER (N = 184)23 59 | EXCITE (N = 353)31 |
Study masking | Double | Double | Double | Single |
Study duration | 24 months | 24 months | 24 months | 12 months |
Lesion type† (percentage of patients with PC/MC/ONC) | Minimally classic and occult (with no classic) CNV (0.1/36.9/63.0) | Predominantly classic CNV (96.9/2.8/0.2) | All CNV types (18.0/38.6/43.0) | All CNV types (20.7/40.2/39.1) |
Visit regimen in | Monthly | Monthly | Quarterly | Monthly for control arm |
maintenance phase | Quarterly for study arms | |||
Ranibizumab regimen in | Monthly | Monthly | Quarterly | Monthly for control arm |
maintenance phase | Quarterly for study arms | |||
No of ranibizumab injections in maintenance phase (over | 9 | 9 | 3 | 9 for control arm 3 for study arms |
first 12-month period) |
Key baseline and efficacy results | Ranibizumab 0.5 mg‡ (n = 240) | Sham control (n = 238) | Ranibizumab 0.5 mg‡ (n = 139) | Verteporfin control (n = 143) | Ranibizumab 0.5 mg‡ (n = 61) | Sham control (n = 63) | Ranibizumab 0.3 mg control (n = 101) | Ranibizumab 0.3 mg (n = 104) | Ranibizumab 0.5 mg (n = 88) |
Mean (SD) size of CNV at baseline (optic-disc area) | 4.3 (2.5) | 4.3 (2.4) | 1.3 (1.2) | 1.5 (1.3) | 3.3 (2.3) | 3.6 (3.2) | NA | NA | NA |
Mean (SD) VA at baseline (letters) | 53.7 (12.8) | 53.6 (14.1) | 47.1 (13.2) | 45.5 (13.1) | 53.7 (15.5) | 55.1 (13.9) | 56.5 (12.2) | 55.8 (11.8) | 57.7 (13.1) |
Stabilisation of VA§ (percentage of patients) | 90.0* | 52.9 | 89.9** | 65.7 | 82.0** | 41.3 | NA | NA | NA |
Improvement in VA¶ (percentage of patients) | 33.3* | 3.8 | 41.0** | 6.3 | 8.2 | 4.8 | NA | NA | NA |
Mean VA change from baseline (letters) | |||||||||
After three initial doses | +5.9* | −3.7 | +10.0* | −2.5 | +4.3 | −8.7 | +7.1 | +6.2 | +5.9 |
At 12 months | +7.2* | −10.4 | +11.3* | −9.5 | −0.2** | −16.3 | +8.0 | +4.0 | +2.8 |
At 24 months | +6.6* | −14.9 | +10.7* | −9.8 | −2.2** | −21.4 | NAP | NAP | NAP |
*p<0.001; **p<0.0001; data are for the intent-to-treat population; the last observation carried forward method was used to calculate missing data;
†Additional inclusion criteria for all studies: CNV comprised ⩾50% of the lesion; BCVA between 20/40 and 20/320. In the MARINA and PIER studies, evidence of recent disease progression was also required for eyes with minimally classic or occult (with no classic) CNV.
‡Ranibizumab 0.3 mg was also investigated; results are shown only for the licensed 0.5 mg dose.
§A loss of <15 letters was considered to be stabilisation of VA; 24-month data shown for MARINA/ANCHOR/PIER; 12-month data shown for EXCITE.
¶Improvement in VA was defined as an increase of ⩾15 letters; 24-month data shown for MARINA/ANCHOR/PIER; 12-month data shown for EXCITE.
BCVA, best-corrected visual acuity; CNV, choroidal neovascularisation; MC, minimally classic; NA, not available; NAP, not applicable; ONC, occult (with no classic); PC, predominantly classic; SD, standard deviation; VA, visual acuity.