Summary table of uncontrolled ranibizumab clinical trials and key efficacy outcomes
| Study design | PrONTO (N = 40)32 | SUSTAIN (N = 531; interim data available for n = 69)30 | SAILOR Cohort 1 (N = 2378)29 |
| Study type | Open-label, single-centre, non-randomised, investigator-sponsored | Open-label, multicentre, non-randomised | Single-masked, multicentre, randomised |
| Study duration | 24 months | 12 months | 12 months |
| Lesion type (percentage of patients with PC/MC/ONC if data available) | All CNV types* (17.5/57.5/25) | All CNV types† | All CNV types |
| Visit regimen in maintenance phase | Monthly | Monthly | Quarterly |
| Ranibizumab regimen in maintenance phase | Individualised | Individualised | Individualised |
| Mean (range) no ranibizumab injections in maintenance phase | 2.6 (0–10) | 2.3 (0–7) | 1.6 (range NA) |
| Key baseline and efficacy results | Ranibizumab 0.5 mg (n = 40) | Ranibizumab 0.3 mg (n = 69; interim data) | Ranibizumab 0.5 mg‡ (n = 1209; 490 treatment-naïve; 719 previously treated) |
| Mean (SD) size of CNV at baseline | NA | NA | NA |
| Mean (SD) VA at baseline (letters) | 56.2 | 54.7 (11.0) | NA |
| Stabilisation of VA at 12 months§ (percentage of patients) | 95.0 | NA | NA |
| Improvement in VA at 12 months¶ (percentage of patients) | 35.0 | NA | 19.3 (treatment-naïve) |
| 16.5 (previously treated) | |||
| Mean VA change from baseline (letters) | |||
| After three initial doses | +10.8 | +9.2 | +7.0 (treatment-naïve) |
| +6.0 (previously treated) | |||
| At 12 months | +9.3 | +6.7 | +2.3 (both groups) |
| At 24 months | +10.7 | NAP | NAP |
SUSTAIN data are for the intent-to-treat population; the last observation carried forward method was used to calculate missing data.
*Additional PrONTO inclusion criteria: BCVA between 20/40 and 20/400 (Snellen equivalent, assessed using Early Treatment Diabetic Retinopathy Study charts); optical coherence tomography central retinal thickness ⩾300 μm; evidence of progression.
†Additional SUSTAIN inclusion criteria: CNV comprised ⩾50% of the lesion; BCVA between 20/40 and 20/320.
‡Ranibizumab 0.3 mg was also investigated; results are only shown for the licensed 0.5 mg dose.
§A loss of <15 letters was defined to be stabilisation of VA.
¶Improvement in VA was defined as an increase of ⩾15 letters.
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.