The only FDA-approved anti-VEGF for diabetic retinopathy (DR) with
or without DME 1
DR Progression | Efficacy | Safety | Patient Cases
Significant regression in diabetic retinopathy
LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic retinopathy, and for treatment of patients with diabetic macular edema (DME).
RISE & RIDE: Patients With DME
RISE & RIDE study design 8,11
RISE and RIDE (N=759) were 2 methodologically identical, randomized, double-masked, sham injection–controlled, Phase III pivotal trials that studied the efficacy and safety of LUCENTIS 0.3 mg and 0.5 mg administered monthly to patients with DR and DME at baseline. The mean age was 62 years (range: 21–91). The primary outcome was the proportion of patients gaining ≥15 letters at 2 years. Following 3 years of study participation, patients could enroll in an open-label extension study.
LUCENTIS 0.3 mg is recommended to be administered by intravitreal injection once a month (~28 days). 1
ETDRS-DRSS, Early Treatment Diabetic Retinopathy Scale Diabetic Retinopathy Severity Score; NPDR, non-proliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy.
≥2- AND ≥3-STEP ETDRS-DRSS IMPROVEMENTS AT 2 YEARS 1
Estimated differences (95% CI) 1:
- ≥2-step: 31% (21%, 40%)
in RISE and 35% (26%, 44%) in RIDE
- P<0.05 for all time points comparing LUCENTIS 0.3 mg to sham from month 3 through month 24
- ≥3-step: 9% (4%, 14%) in RISE and 15% (7%, 22%) in RIDE
- P<0.05 for all time points comparing LUCENTIS 0.3 mg to sham from month 12 through month 24
VISION IMPROVEMENT IN RISE & RIDE 1,8,9
Vision gains through 2 years, sustained at 3 years
Primary end point: Proportion of patients gaining ≥15 letters at 2
years. 11
OPEN-LABEL EXTENSION (OLE): 36 THROUGH 48 MONTHS
4.5 mean injections for the total study during OLE (n=298). 19
~20% of patients maintained vision with no further injections through year 4, following 3 years of therapy (n=58). 1
VA, visual acuity.
†At least 12 months of
follow-up. Crossover to LUCENTIS (0.5 mg) was optional.
‡ P<0.01 for all time points comparing LUCENTIS
0.3 mg vs sham through 2 years. 1
Protocol S: Patients With or Without DME
Protocol S 1,14
A randomized, active-controlled study that evaluated LUCENTIS 0.5 mg
vs panretinal photocoagulation (PRP) in DR patients with and without
DME. The mean age was 51 years (range: 20–83). Baseline ETDRS-DRSS
ranged from 20 to 85. The primary outcome was mean change in visual
acuity letter score from baseline to 2 years.
- All eyes in the LUCENTIS
group (n=191) received a baseline 0.5 mg intravitreal injection
followed by 3 monthly injections. Further treatments were guided
by prespecified retreatment criteria. FDA approval was based on an
analysis of the LUCENTIS arm of Protocol S
- All eyes in the PRP group (n=203) received initial PRP. After completion of PRP, 45% received additional PRP—median time from baseline to additional PRP was approximately 7 months. Of patients in the PRP group, 53% (n=90) received LUCENTIS treatment during the study (35% from baseline [n=72]). Initiation and retreatment with LUCENTIS for DME was at investigator discretion 14
Efficacy and safety data for DR was derived from RISE, RIDE, and Protocol S. 1
LUCENTIS 0.3 mg is recommended to be administered by intravitreal
injection once a month (~28 days). 1
≥2- AND ≥3-STEP ETDRS-DRSS IMPROVEMENTS AT 2 YEARS
1
Error bars represent 95% confidence intervals.
Estimated differences (95% CI) for percentage at 2 years 1:
- ≥2-step: 58.5% (43.5%, 73.6%) for eyes with baseline DME and 37.8% (30%, 45.7%) for eyes without baseline DME
- ≥3-step: 31.7% (17.5%, 46%) for eyes with baseline DME and 28.4% (21.1%, 35.6%) for eyes without baseline DME
CHANGES IN VISUAL ACUITY OVER TIME 14
All eyes in the LUCENTIS group (n=191) received a baseline 0.5 mg intravitreal injection followed by 3 monthly injections. Further treatments were guided by prespecified retreatment criteria.
LUCENTIS 0.3 mg is recommended to be administered by intravitreal injection once a month (~28 days). 1
Primary outcome: Mean change in visual acuity letter score from baseline to 2 years.
OVERALL COHORT (n=191)
Error bars represent 95% confidence intervals.
In line with the overall cohort, a prespecified subgroup analysis evaluated VA change in patients with and without baseline DME. Protocol S subgroup analyses were not powered to show differences between subgroups. 14
EYES WITHOUT BASELINE DME (n=148) 14
EYES WITH BASELINE DME (n=41) 14
Error bars represent 95% confidence intervals.
CI, confidence interval; VA, visual acuity; VEGF,
vascular endothelial growth factor.
