Statistically significant mean VA gains through 6 months 6
LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).
LUCENTIS 0.5 mg (0.05 mL of 10 mg/mL LUCENTIS solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
Study design 1
In BRAVO, patients with macular edema following branch or hemi-RVO received monthly LUCENTIS 0.3 mg, 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.
- 54% of sham-treated patients received rescue grid laser vs 20% of LUCENTIS-treated patients in the first 6 months. Best corrected visual acuity (BCVA) was measured at a distance of 4 meters (26/131=19.8%; 71/132=53.8%)
In BRAVO and CRUISE, patients received monthly injections of LUCENTIS for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced, on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly.
In BRAVO, the primary end point was mean change in BCVA at 6 months 6
- In patients with branch retinal vein occlusion (BRVO), LUCENTIS monthly provided a mean gain of 18.3 letters at 6 months compared with 7.3 letters with sham (P<0.01) 1,6
BRAVO: Select safety through 6 months 6,9
SELECT OCULAR ADVERSE EVENTS 6,9
ANTIPLATELET TRIALISTS' COLLABORATION-DEFINED ARTERIAL
MOST COMMON ADVERSE EVENTS OCCURRING IN >10% OF PATIENTS 9
Additional non-ocular Serious Adverse Events (SAEs) in BRAVO in the LUCENTIS 0.5 mg group reported as potentially associated with systemic vascular endothelial growth factor (VEGF) inhibition included unstable angina (n=1), post-colonoscopy hemorrhage (n=1), and intestinal perforation (n=1). 6
† Reported as serious. 6
‡ Reported as fatal hemorrhagic stroke. 6
Statistically significant mean VA gains through 6 months in patients with macular edema following central RVO 7
Study design 1
In 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.
In CRUISE, the primary end point was mean change in BCVA at 6 months 7
CRUISE: Select safety through 6 months 7,9
SELECT OCULAR ADVERSE EVENTS 7,9
APTC-DEFINED ATEs 7,9
MOST COMMON ADVERSE EVENTS OCCURRING IN ≥5% OF PATIENTS 9
Additional non-ocular 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. 7
§ The same patient had iritis and vitritis.
ll Reported as serious. 7