LUCENTIS is indicated for the treatment of patients with diabetic retinopathy and for treatment of patients with diabetic macular edema (DME).
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).7
Estimated differences (95% CI)7:
Vision gains through 2 years, sustained at 3 years
Primary end point: Proportion of patients gaining ≥15 letters at 2 years.9
4.5 mean injections for the total study during OLE (n=298).10
~20% of patients maintained vision with no further injections through year 4, following 3 years of therapy (n=58).7
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 discretion11
Efficacy and safety data for DR were derived from RISE, RIDE, and Protocol S.7
LUCENTIS 0.3 mg is recommended to be administered by intravitreal injection once a month (~28 days).7
Error bars represent 95% confidence intervals.
Estimated differences (95% CI) for percentage at 2 years7:
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).7
Primary outcome: Mean change in visual acuity letter score from baseline to 2 years.
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.11
Error bars represent 95% confidence intervals.
CI, confidence interval.
Ip MS, et al. Arch Ophthalmol. 2012;130:1145-1152.
Ip MS, et al. Arch Ophthalmol. 2012;130:1145-1152.
Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991;98:823-833.
Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991;98:823-833.
American Academy of Ophthalmology. International clinical diabetic retinopathy disease severity scale detailed table. October 2002. http://www.icoph.org/dynamic/attachments/resources/diabetic-retinopathy-detail.pdf. Accessed April 26, 2017.
American Academy of Ophthalmology. International clinical diabetic retinopathy disease severity scale detailed table. October 2002. http://www.icoph.org/dynamic/attachments/resources/diabetic-retinopathy-detail.pdf. Accessed April 26, 2017.
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2014. Available at: www.aao.org/ppp.
American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2014. Available at: www.aao.org/ppp.
Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987;27:239-253.
Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987;27:239-253.
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
Nguyen QD, et al; RISE and RIDE Research Group. Ophthalmology. 2012;119:789-801.
Nguyen QD, et al; RISE and RIDE Research Group. Ophthalmology. 2012;119:789-801.
Brown DM, et al; RISE and RIDE Research Group. Ophthalmology. 2013;120:2013-2022.
Brown DM, et al; RISE and RIDE Research Group. Ophthalmology. 2013;120:2013-2022.
Boyer DS, et al; RIDE and RISE Research Group. Ophthalmology. 2015;122:2504-2513.
Boyer DS, et al; RIDE and RISE Research Group. Ophthalmology. 2015;122:2504-2513.
Gross JG, et al; Writing Committee for the Diabetic Retinopathy Clinical Research Network. JAMA. 2015;314:2137-2146.
Gross JG, et al; Writing Committee for the Diabetic Retinopathy Clinical Research Network. JAMA. 2015;314:2137-2146.
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