Ranibizumab for the treatment of degenerative ocular conditions

Figures & data

Table 1 Summary of the most important clinical ranibizumab trials

Study	Design	Number of patients	Key results
Wet AMD
ANCHOR^Citation78,Citation79	Multicenter, randomized, double-masked, active-treatment-controlled clinical trial, 2-year	423	1) 94.3% of patients given 0.3 mg of ranibizumab and 96.4% of those given 0.5 mg lost ≥15 letters, as compared with 64.3% of those in the verteporfin group (P<0.001 for each comparison) 2) VA improved by ≥15 letters in 35.7% of the 0.3 mg group and 40.3% of the 0.5 mg group, compared with 5.6% of the verteporfin group (P<0.001 for each comparison)
MARINA^Citation80	Multicenter, 2-year, double-blind, sham-controlled study	716	VA improved by ≥15 letters in 24.8% of the 0.3 mg group and 33.8% of the 0.5 mg group, as compared with 5.0% of the sham-injection group (P<0.001 for both doses)
PIER^Citation93,Citation124	Phase IIIb, multicenter, randomized, double-masked, 2-year, sham injection-controlled trial	184	VA decreased an average of 21.4, 2.2, and 2.3 letters from baseline in the sham, 0.3 mg, and 0.5 mg groups (P<0.0001 for each ranibizumab group vs sham)
PrONTO^Citation136	2-year prospective, uncontrolled, variable-dosing regimen based on OCT	40 (37 completed the study)	Mean VA improved by 11.1 letters (P<0.001) and the OCT-CRT decreased by 212 μm (P<0.001). These outcomes were achieved with an average of 9.9 injections over 24 months
RVO
BRAVO^Citation128	Multicenter, double-masked, 6-month trial	397	Patients treated with ranibizumab reported greater mean improvements in visual function, with substantial differences observed as early as month 1 compared with sham patients (all P<0.05)
CRUISE^Citation128	Multicenter, double-masked, 6-month trial	392	Patients treated with ranibizumab reported greater mean improvements in visual function, with substantial differences observed as early as month 1 compared with sham patients (all P<0.05)
RETAIN^Citation109	Prospective follow-up of a subset of patients from two Phase III trials (Genentech-sponsored ranibizumab study RVO trials). Mean follow-up of 49.0 months for BRVO patients and 49.7 months for CRVO	66	1) 50% of BRVO patients had edema resolution; 80% of BRVO patients had a final VA ≥20/40 2) 44% of CRVO patients had edema resolution; 64.3% of patients with resolved ME vs 27.8% of patients with unresolved ME had a final VA ≥20/40
DME
RESOLVE^Citation43	12-month, multicenter, sham-controlled, double-masked study	151	1) VA improved from baseline by 10.3±9.1 letters with ranibizumab and declined by 1.4±14.2 letters with sham (P<0.0001) 2) Mean CRT reduction was 194.2±135.1 μm with ranibizumab and 48.4±153.4 μm with sham (P<0.0001)
RISE^Citation106	Phase III, randomized, multicenter, double-masked, 3-year trials, sham injection-controlled for 2 years	377	Greater proportion of ranibizumab-treated patients had ≥15 letters gain in vision compared with placebo group, with 51.2% for the 0.3 mg ranibizumab group, 41.6% for the 0.5 mg ranibizumab group, vs 22.0% for the placebo groups (P<0.0001)
RIDE^Citation106	Phase III, randomized, multicenter, double-masked, 3-year trials, sham injection-controlled for 2 years	382	Greater proportion of ranibizumab-treated patients had ≥15 letters gain in vision compared with placebo group, with 36.8% for the 0.3 mg ranibizumab group, 40.2% for the 0.5 mg ranibizumab group, vs 19.2% for the placebo groups (P<0.0001)

Abbreviations: AMD, age-related macular degeneration; BRVO, branch retinal vein occlusion; CRT, central retinal thickness; CRVO, central retinal vein occlusion; DME, diabetic macular edema; ME, macular edema; OCT, optical coherence tomography; RVO, retinal vein occlusion; VA, visual acuity; vs, versus.

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