Published studies providing primary data on ranibizumab in patients with visual impairment or macular oedema secondary to RVO47–53
| Reference | Risard et al47 | Campochiaro et al48 | Spaide et al49 | Campochiaro et al50 |
|---|---|---|---|---|
| Study design | Prospective, open label | Prospective, randomised, masked trial | Randomised, open label | Randomised, uncontrolled |
| Duration (months) | 36 24-month data available | 24 | 12 | 6 |
| Population | Perfused CRVO | BRVO/CRVO | CRVO | BRVO/CRVO |
| Number of patients | 20 | 40 (BRVO, n=20; CRVO, n=20) | 20 | 40 (BRVO, n=20; CRVO, n=20) |
| Ranibizumab treatment | Cohort 1: 0.3 mg (n=5) or 0.5 mg (n=5); 3×monthly then PRN (q3 m monitoring amended to monthly in year 2); Cohort 2: 0.3 mg (n=5) or 0.5 mg (n=5); 3×monthly then PRN (q1 m monitoring) | 0.3 mg or 0.5 mg at BL and months 1 and 2 then PRN after month 12 | 0.5 mg at BL and months 1 and 2, then PRN | 3×monthly 0.3 mg or 0.5 mg |
| Mean number of ranibizumab injections | NR | 2 (BRVO); 3.5 (CRVO) | 8.5 | NR |
| Mean BCVA change at month 6 (letters) | NR | 0.3 mg and 0.5 mg (pooled):* +16.1 (BRVO); +12.0 (CRVO) | 0.5 mg: +10.4 (p=0.001)* | 0.3 mg: +11 (CRVO)† 0.5 mg: +3 (CRVO)† 0.3 mg: +15 (BRVO)† 0.5 mg: +14.5 (BRVO)† |
| Mean BCVA change at month 12 (letters) | Cohort 1: +10.0 Cohort 2: +3.7 | 0.3 mg and 0.5 mg (pooled):‡ +17.8 (BRVO); +8.5 (CRVO) | 0.5 mg: +18.5 | NR |
| Patients gaining ≥15 letters at month 12 (%) | Cohort 1: 30 Cohort 2: 30 | 0.3 mg and 0.5 mg (pooled):‡ 59 (BRVO); 28.6 (CRVO) | 0.5 mg: 56.3 | 0.3 mg pooled: 70 0.5 mg pooled: 40 |
| OCT change at month 6 | NR | 0.3 mg and 0.5 mg (pooled) CFT:* –264.4 μm (BRVO); –260.5 μm (CRVO) | 0.5 mg: –317 μm CMT | 0.3 mg: –220 μm (CRVO) 0.5 mg: –86 μm (CRVO) 0.3 mg: –213.5 μm (BRVO) 0.5 mg: –214.5 μm (BRVO) |
| OCT change at month 12 | Cohort 1: –304 μm CRT* Cohort 2: –282 μm CRT* | 0.3 mg and 0.5 mg (pooled) CFT:‡ –229.5 μm (BRVO); –129 μm (CRVO) | 0.5 mg: –389 μm CFT | NR |
| Incidence of ocular AEs (n) | 1 increased oedema/ischaemia 1 myocardial infarction 1 cerebrovascular accident | NR | NR | 0 treatment-related AEs |
| Reference | Alfaro et al52 | Pieramici et al53 | Wykrota et al54 |
|---|---|---|---|
| Study design | Non-randomised, open label | Randomised, open label | Non-randomised, interventional case series |
| Duration (months) | 12 | 24 | 6 |
| Population | BRVO | CRVO | BRVO/CRVO |
| Number of patients | 20§ | 10 | 16 (BRVO, n=11; CRVO, n=5) |
| Ranibizumab treatment | 0.3 mg or 0.5 mg at BL and months 1 and 2, then PRN | 0.3 mg or 0.5 mg at BL and months 1 and 2, then PRN | 0.5 mg** |
| Mean number of ranibizumab injections | 7 | 4.5 | 3.2 |
| Mean BCVA change at month 6 (letters or Snellen equivalent) | 0.3 mg and 0.5 mg (pooled): +15.5 | 0.3 mg: +8.0 0.5 mg: 3 | 0.5 mg: 20/400 at BL to 20/100 at month 6 (p=0.01 at month 6 compared with BL) |
| Mean BCVA change at month 12 (letters) | 0.3 mg and 0.5 mg (pooled): +16.2 | 0.3 mg and 0.5 mg (pooled): +1¶ (p=0.859) | NR |
| Patients gaining ≥15 letters at month 12 (%) | 0.3 mg and 0.5 mg (pooled): 55 | 0.3 mg: 20¶ 0.5 mg: 40¶ | NR |
| OCT change at month 6 | 0.3 mg and 0.5 mg (pooled): –164.4 μm CRT | 0.3 mg and 0.5 mg (pooled): –88 μm CRT (p=0.154) | 0.5 mg: –366 μm CRT |
| OCT change at month 12 | 0.3 mg and 0.5 mg (pooled): –167.9 μm CRT | NR | NR |
| Incidence of ocular AEs (n) | 0.3 mg and 0.5 mg (pooled): 0 SAEs | 0.3 mg and 0.5 mg (pooled): 0 SAEs | 0.5 mg: 0 |
*3-month data provided. †Median values reported. ‡24-month data provided for 17 patients with BRVO and 14 patients with CRVO.
§Expected enrolment, data available for 11 patients.
¶9-month data provided.
**Dosing regimen not provided.
AE, adverse event; BCVA, best-corrected visual acuity; BL, baseline; BRVO, branch retinal vein occlusion; CFT, central foveal thickness; CMT, central macular thickness; CRT, central retinal thickness; CRVO, central retinal vein occlusion; NR, not reported; OCT, optical coherence tomography; PRN, as needed; q1 m, every month; q3 m, every 3 months; RVO, retinal vein occlusion; SAE, serious adverse event.