RVO

LUCENTIS is approved to treat patients with macular edema following retinal vein occlusion (RVO)

LUCENTIS monthly demonstrated significant improvements in macular edema following BRVO through month 6

In BRVO, LUCENTIS monthly demonstrated statistically significant mean VA gains through month 6

The safety and efficacy of LUCENTIS were assessed in two randomized, double-masked, 1-year studies in patients with macular edema following RVO. Sham controlled data are available through Month 6. Patient age ranged from 20 to 91 years, with a mean age of 67 years (266 patients; LUCENTIS 0.5 mg, 261 patients; sham, 262 patients) were enrolled. All patients completing Month 6 were eligible to receive LUCENTIS injections guided by pre-specified re-treatment criteria until the end of the studies at Month 12. In Study 1 (BRAVO), patients with macular edema following branch or hemi-RVO, received monthly LUCENTIS 0.5 mg intravitreal injections or monthly sham injections for 6 months. All patients were eligible for macular focal/grid laser treatment beginning at Month 3 of the 6-month treatment period.

In BRAVO, 54.5% of sham-treated patients received rescue grid laser vs 19.8% of LUCENTIS-treated patients in the first 6 months. VA was measured at a distance of 4 meters.3

*Primary end point was mean change in BCVA at month 6.1
BRVO, branch retinal vein occlusion.

  • In BRVO, LUCENTIS monthly provided a mean VA gain of 18.3 letters at 6 months compared with 7.3 letters with sham (P<0.0001)1,3

In BRVO, LUCENTIS monthly demonstrated statistically significant mean CFT reductions through month 6

CFT was not evaluated as a means to guide treatment decisions.1

Ocular and systemic safety information through month 6

*Reported as serious.1
†Reported as fatal hemorrhagic stroke.1

Additional nonocular SAEs in BRAVO in the LUCENTIS 0.5 mg group reported as potentially associated with systemic VEGF inhibition included unstable angina (n=1), postcolonoscopy hemorrhage (n=1), and intestinal perforation (n=1).1

LUCENTIS monthly demonstrated significant improvements in macular edema following CRVO through month 6

In CRVO, LUCENTIS monthly demonstrated statistically significant mean VA gains through month 6

In Study 2 (CRUISE), patients with macular edema following central RVO received monthly LUCENTIS 
0.5 mg intravitreal injections or monthly sham injections for 6 months.

VA was measured at a distance of 4 meters.3

*Primary end point was mean change in BCVA at month 6.4
CRVO, central retinal vein occlusion.

  • In CRUISE, LUCENTIS monthly provided a mean VA gain of 14.9 letters at 6 months compared with 0.8 letters with sham (P<0.0001)4

In CRVO, LUCENTIS monthly demonstrated statistically significant mean CFT reductions through month 6

CFT was not evaluated as a means to guide treatment decisions.4

Ocular and systemic safety information through month 6

*The same patient had iritis and vitritis.4
†Reported as serious.4

Additional nonocular SAEs in CRUISE in the LUCENTIS 0.5 mg group reported as potentially associated with systemic VEGF inhibition included angina pectoris (n=1) and transient ischemic attack (n=1), which were reported in the same patient.4

  • References:
  • 1. Campochiaro PA, Heier JS, Feiner L, et al; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1102-1112.
  • 2. Data on file. Genentech, Inc. South San Francisco, CA.
  • 3. LUCENTIS package insert. South San Francisco, CA: Genentech, Inc; 2015.
  • 4. Brown DM, Campochiaro PA, Singh RP, et al; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1124-1133.