Studied extensively in patients with wet AMD 1-3
LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD).
Randomized, double-masked, 2-year study of LUCENTIS 0.5 mg (n=240) vs sham (n=238) in patients with minimally classic or occult CNV lesions and BCVA ≤20/320.
PRIMARY OUTCOME: 1 YEAR
% losing <15 ETDRS letters.
Randomized, double-masked, 2-year study of LUCENTIS 0.5 mg (n=139) vs active control (vPDT, n=143) in patients with predominantly classic CNV lesions.
PRIMARY OUTCOME: 1 YEAR
% losing <15 ETDRS letters.
PRIMARY OUTCOMES 1
“Maintained” was defined as losing <15 ETDRS letters from baseline.
†Adjusted estimate based on the stratified model;
Rapid & sustained vision gains 1-3,9
MARINA & ANCHOR: MEAN CHANGE IN BCVA FROM BASELINE
BCVA, best corrected visual acuity; CI, confidence interval; CNV, choroidal neovascularization; ETDRS, Early Treatment Diabetic Retinopathy Scale; vPDT, verteporfin photodynamic therapy.
The only anti-VEGF approved for PRN dosing in patients with wAMD
after 3 monthly loading doses
Randomized, double-masked, active treatment–controlled, 2-year study
of LUCENTIS 0.5 mg (N=550) monthly or less frequently in patients with
- Less-frequent regimens were 3 monthly doses followed by PRN schedules guided by assessment and prespecified retreatment criteria
- The patient population was similar to MARINA and ANCHOR, and patients with PEDs were included
PRIMARY OUTCOME – 1 YEAR: Mean change in BCVA from baseline at year 1 with a prespecified noninferiority comparison of LUCENTIS monthly and less-frequent dosing (margin of 4 letters).
THE PRIMARY END POINT WAS NOT MET. AT YEAR 1, THE LESS-FREQUENT DOSING ARM DID NOT MEET THE NONINFERIORITY COMPARISON. 2
PATIENTS REQUIRED DIFFERENT DOSING REGIMENS 1,10
In HARBOR, patients received 3 initial monthly doses followed by PRN
dosing with regular monthly assessment through 2 years. Monthly dosing
is more effective. Patients should be regularly assessed to evaluate
BCVA, best corrected visual acuity; PED, pigment epithelial detachment; PRN, pro re nata; VEGF, vascular endothelial growth factor.
Mean change in BCVA from baseline
HARBOR: 2-YEAR RESULTS 10
Compared to the less-frequent dosing arm, patients in the monthly
treatment arm gained 1 to 2 additional letters on average. After 3
initial monthly doses, patients in the less-frequent dosing arm
maintained clinically meaningful VA gains through year 1 and year
‡Among patients who completed the 2-year study.
Post hoc analysis of HARBOR patients with and without PED at
Limitations of this analysis include that it is post hoc (ie, not
prespecified). The statistical significance of these results cannot be
determined, and the clinical significance of these results is
A post hoc analysis of HARBOR examined the effect of a baseline PED on visual outcomes
- At baseline, 54.5% (598/1097) of patients presented with PED
- At 2 years, the number of injections was similar in patients with and without PED at baseline (14.0 vs 12.5, respectively)
ETDRS, Early Treatment Diabetic Retinopathy Scale; VA, visual acuity.
VIEW 1 & 2 were two randomized, double-masked, 96-week, active treatment–controlled studies of LUCENTIS 0.5 mg monthly vs aflibercept 2.0 mg monthly or every 8 weeks, or aflibercept 0.5 mg monthly in patients with wAMD (N=2457).
PRIMARY OUTCOME: MAINTENANCE† OF VISION AT 52 WEEKS
Noninferiority of aflibercept arms to LUCENTIS (margin of 10%) in the proportion of eyes maintaining vision.
†“Maintained” was defined as losing <15 ETDRS letters from baseline.
PRIMARY OUTCOMES 22,23
‡Percentages reflect combination of aflibercept 2Q4 (2.0 mg every 4 weeks) and 2Q8 (2.0 mg every 8 weeks) treatment groups. Last observation carried forward: full analysis set. 22
VIEW 1 & 2 were two randomized, double-masked, 96-week, active
treatment–controlled studies of LUCENTIS 0.5 mg monthly vs aflibercept
2.0 mg monthly or every 8 weeks, or aflibercept 0.5 mg monthly in
patients with wAMD (N=2457).
PRIMARY OUTCOME: MAINTENANCE§ OF VISION AT 52 WEEKS
Comparison of aflibercept arms to LUCENTIS (margin of 10%) in the
proportion of eyes maintaining vision.
§“Maintained” was defined as losing <15 ETDRS letters from baseline.
||A total of 2412 patients were treated and evaluated for efficacy in VIEW 1 and VIEW 2 studies. 23
¶LUCENTIS 0.5 mg was the active
control in the VIEW 1 and 2 trials for the prespecified primary and
secondary end points at week 52. 21,23
#During weeks 52-96, patients were evaluated every 4 weeks and treated at least every 12 weeks. Patient dosing schedules were individualized from weeks 52 to 96 using a modified 12- week dosing regimen. 21,23
**The primary outcome of VIEW 1 and 2 was the noninferiority of aflibercept to LUCENTIS in the proportion of patients maintaining VA at 52 weeks (losing <15 letters) with exploratory end points at week 96. 21,23
BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Scale; Q4W, every 4 weeks; Q8W, every 8 weeks; VA, visual acuity.
Select safety at 2 years in wAMD pivotal trials†
ATE, arterial thromboembolic event; PDT,
†Data derived from LUCENTIS package insert and safety data from MARINA, ANCHOR, PIER, and HARBOR pivotal trials.
‡APTC ATEs were defined as nonfatal myocardial infarction (MI), nonfatal stroke, vascular death, and death of unknown cause. Some patients may have experienced multiple events. 2