efficacy of Lucentis have been assessed in three randomised, double-masked, sham- or active-controlled studies of 24 months duration in patients with neovascular AMD. A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
In study FVF2598g (MARINA), 716 patients with minimally classic or occult with no classic choroidal neovascularisation (CNV) received monthly intravitreal injections of Lucentis 0.3 mg (n=238) or 0.5 mg (n=240) or sham (n=238) injections.
In study FVF2587g (ANCHOR), 423 patients with predominantly classic CNV lesions received either: 1) monthly intravitreal injections of Lucentis 0.3 mg and sham PDT (n=140); 2) monthly intravitreal injections of Lucentis 0.5 mg and sham PDT (n=140); or 3) sham intravitreal injections and active verteporfin PDT (n=143). Sham or active verteporfin PDT was given with the initial Lucentis injection and every 3 months thereafter if fluorescein angiography showed persistence or recurrence of vascular leakage.
Key outcome measures are summarised in Tables 1, 2 and Figure 1.
Table 1 Outcomes at Month 12 and Month 24 in study FVF2598g (MARINA)
Outcome measure
Month
Sham
(n=238)
Lucentis 0.5 mg
(n=240)
Loss of <15 letters in visual acuity (%)a
(maintenance of vision, primary endpoint)
Month 12
62%
95%
Month 24
53%
90%
Gain of ≥15 letters in visual acuity (%)a
Month 12
5%
34%
Month 24
4%
33%
Mean change in visual acuity (letters) (SD)a
Month 12
-10.5 (16.6)
+7.2 (14.4)
Month 24
-14.9 (18.7)
+6.6 (16.5)
a p<0.01
Table 2 Outcomes at Month 12 and Month 24 in study FVF2587g (ANCHOR)
Outcome measure
Month
Verteporfin PDT
(n=143)
Lucentis 0.5 mg
(n=140)
Loss of <15 letters in visual acuity (%)a
(maintenance of vision, primary endpoint)
Month 12
64%
96%
Month 24
66%
90%
Gain of ≥15 letters in visual acuity (%)a
Month 12
6%
40%
Month 24
6%
41%
Mean change in visual acuity (letters) (SD)a
Month 12
-9.5 (16.4)
+11.3 (14.6)
Month 24
-9.8 (17.6)
+10.7 (16.5)
a p<0.01
Figure 1 Mean change in visual acuity from baseline to Month 24 in study FVF2598g (MARINA) and study FVF2587g (ANCHOR)
Results from both trials indicated that continued ranibizumab treatment may also be of benefit in patients who lost ≥15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Study FVF3192g (PIER) was a randomised, double-masked, sham-controlled study designed to assess the safety and efficacy of Lucentis in 184 patients with all forms of neovascular AMD. Patients received Lucentis 0.3 mg (n=60) or 0.5 mg (n=61) intravitreal injections or sham (n=63) injections once a month for 3 consecutive doses, followed by a dose administered once every 3 months. From Month 14 of the study, sham-treated patients were allowed to cross over to receive ranibizumab and from Month 19, more frequent treatments were possible. Patients treated with Lucentis in PIER received a mean of 10 total treatments.
The primary efficacy endpoint was mean change in visual acuity at 12 months compared with baseline
