DME and DR w/DME

LUCENTIS is indicated for the treatment of patients; with diabetic macular edema (DME) and Diabetic Retinopathy (Non Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR)) in patients with Diabetic Macular Edema (DME)

DME patients had improvements in vision and in retinopathy

Two methodologically identical, 3-year, Phase III, randomized, double-masked, sham injection-controlled studies that assessed the safety and efficacy of two doses (0.3 mg, 0.5 mg) of LUCENTIS in 759 patients with DME ≥18 years with baseline BCVA and CST of 20/40 to 20/320 approximate Snellen equivalent and ≥275 microns in the study eye, respectively. The primary end point was measured by the proportion of patients who gained ≥15 ETDRS letters in BCVA score from baseline at 24 months. Key exploratory end points included ≥2-step and ≥3-step ETDRS-RSS improvement at 24 months. Following the third year of RISE and RIDE, patients were able to enroll in an open-label extension study.3-5

aD-1: Sham, n=130; LUCENTIS 0.3 mg, n=125. D-2: Sham, n=127; LUCENTIS 0.3 mg, n=125
bAdjusted estimate based on stratified model; p≤0.01

Patients gained an average of 9.1 letters at month 6 and 11.7 letters at month 242

*LUCENTIS is approved for a 0.3 mg dose in DME.1
†Crossover to LUCENTIS 0.5 mg was optional.3

BCVA, best corrected visual acuity; CST, central subfield thickness; ETDRS, Early Treatment Diabetic Retinopathy Scale; ETDRS-RSS, Early Treatment Diabetic Retinopathy Scale Retinopathy Severity Score.

Patients had baseline Early Treatment Diabetic Retinopathy Study (ETDRS) Retinopathy Severity Scores (ETDRS-RSS) ranging from 10 to 75. At baseline, 62% of patients had NPDR (ETDRS-RSS less than 60) and 31% had PDR (ETDRS-RSS greater than or equal to 60).

  • In RISE (LUCENTIS 0.3 mg, n=117; sham, n=115) and RIDE (LUCENTIS 0.3 mg, n=117; sham, n=124), of the 759 patients enrolled, 746 patients had a baseline assessment of fundus photography. Patients had a baseline ETDRS-RSS ranging from 10 to 75.1 †Adjusted estimate based on stratified model.
  • References:
  • 1. LUCENTIS package insert
  • 2. Data on file. Genentech, Inc. South San Francisco, CA.
  • 3. Brown DM, Nguyen QD, Marcus DM, et al; RISE and RIDE Research Group. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials. Ophthalmology. 2013;120:2013-2022.
  • 4. Nguyen QD, Brown DM, Marcus DM, et al; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119:789-801.
  • 5. Ip MS, Domalpally A, Hopkins JJ, Wong P, Ehrlich JS. Long-term effects of ranibizumab on diabetic retinopathy severity and progression. Arch Ophthalmol. 2012;130:1145-1152.