The first and only anti-VEGF proven effective and safe for diabetic retinopathy (DR) with and without DME 1,13

Significant regression in retinopathy

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic retinopathy (DR), and for treatment of patients with diabetic macular edema (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 in patients with DR and DME at baseline. Following 3 years of study participation, patients could enroll in an open-label extension study.

Dosing 1

LUCENTIS 0.3 mg is recommended to be administered by intravitreal injection once a month (~28 days).

≥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
  • ≥3-step: 9% (4%, 14%) in RISE and 15% (7%, 22%) in RIDE

At baseline, all patients had DME and an Early Treatment Diabetic Retinopathy Severity Scale Diabetic Retinopathy Severity Score (ETDRS-DRSS) ranging from 10 to 75. Of the 759 patients enrolled in RISE and RIDE, 746 had a baseline assessment of fundus photography. 1

Protocol S study design 1,13,14

Protocol S 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. 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.

Dosing

LUCENTIS 0.3 mg is recommended to be administered by intravitreal injection once a month (~28 days).

≥2- AND ≥3-STEP ETDRS-DRSS IMPROVEMENTS AT 2 YEARS 1

Estimated differences (95% CI) at 2 years1:

  • ≥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

CI, confidence interval; VEGF, vascular endothelial growth factor.

Resources
Resources for your patients.
LUCENTIS Direct
Simple, personalized ordering.
LUCENTIS Co-pay Card Program
Support for your patients with commercial insurance.
LUCENTIS Access Solutions
Genentech Access Solutions is your resource for access and reimbursement support services.