Figure 3 Mean change from baseline BCVA over time to Month 6 and Month 12 (BRAVO)
BL=baseline; SE=standard error of mean

Table 6 Outcomes at Month 6 and 12 (CRUISE)

  Sham/Lucentis 0.5 mg

(n=130)
 Lucentis 0.5 mg

(n=130)
 
Mean change in visual acuity at Month 6a (letters) (SD) (primary endpoint)
 0.8 (16.2)
 14.9 (13.2)
 
Mean change in BCVA at Month 12 (letters) (SD)
 7.3 (15.9)
 13.9 (14.2)
 
Gain of ≥15 letters in visual acuity at Month 6a (%)
 16.9
 47.7
Gain of ≥15 letters in visual acuity at Month 12 (%)
 33.1
 50.8
ap<0.0001
Figure 4 Mean change from baseline BCVA over time to Month 6 and Month 12 (CRUISE)
BL=baseline; SE=standard error of mean
In both studies, the improvement of vision was accompanied by a continuous and significant reduction in the macular oedema as measured by central retinal thickness.
In patients with BRVO (BRAVO and extension study HORIZON): After 2 years, subjects that were treated with sham in the first 6 months and subsequently crossed over to ranibizumab treatment had achieved comparable gains in VA (~15 letters) compared to subjects that were treated with ranibizumab from study start (~16 letters). However the number of patients completing 2 years was limited and in HORIZON only quarterly monitoring visits were scheduled. Therefore there is currently insufficient evidence to conclude on recommendations as to when ranibizumab treatment should be initiated in patients with BRVO.
In patients with CRVO (CRUISE and extension study HORIZON): After 2 years, subjects that were treated with sham in the first 6 months and subsequently crossed over to ranibizumab treatment did not achieve comparable gains in VA (~6 letters) compared to subjects that were treated with ranibizumab from study start (~12 letters).
The improvement in visual acuity observed with ranibizumab treatment at 6 and 12 months was accompanied by patient-reported benefits as measured by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) sub-scales related to near and distance activity. The difference between Lucentis 0.5 mg and the control group was assessed at Month 6 with p-values of 0.02 to 0.0002.
Treatment of visual impairment due to CNV secondary to PM
The clinical safety and efficacy of Lucentis in patients with visual impairment due to CNV in PM have been assessed based on the 12-month data of the randomised, double-masked, controlled pivotal study F2301 (RADIANCE). This study was designed to eva luate two different dosing regimens of 0.5 mg ranibizumab given as an intravitreal injection in comparison to verteporfin PDT (vPDT, Visudyne photodynamic therapy). The 277 patients were randomised to one of the following arms:
• Group I (ranibizumab 0.5 mg, dosing regimen driven by “stability” criteria defined as no change in BCVA compared to two preceding monthly eva luations).
• Group II (ranibizumab 0.5 mg, dosing regimen driven by “disease activity” criteria defined as vision impairment attributable to intra- or subretinal fluid or active leakage due to the CNV lesion as assessed by OCT and/or FA).
• Group III (vPDT - patients were allowed to receive ranibizumab treatment as of Month 3).
During the 12 months of the study, patients received on average 4.6 injections (range 1-