LUCENTIS is indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).
LUCENTIS 0.5 mg is recommended to be administered by intravitreal injection once a month (approximately 28 days).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.
VA, visual acuity.
BRAVO: Select safety through 6 months2,3
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|
Any Intraocular Inflamation Event (Iridocyclitis, Iritis, Vitritis) | 0 | 3.1% (4) |
---|---|---|
Cataract | 3.1% (4) | 3.1% (4) |
Endophthalmitis | 0.8% (1)* | 0 |
Intraocular Pressure Increased | 5.4% (7) | 1.5% (2) |
Iris Neovascularization | 0 | 2.3% (3) |
Neovascular Glaucoma | 0 | 0 |
LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|---|
ADVERSE EVENTS, % (n) |
Any Intraocular Inflamation Event (Iridocyclitis, Iritis, Vitritis) | |
0 | 3.1% (4) |
Cataract | |
3.1% (4) | 3.1% (4) |
Endophthalmitis | |
0.8% (1)* | 0 |
Intraocular Pressure Increased | |
5.4% (7) | 1.5% (2) |
Iris Neovascularization | |
0 | 2.3% (3) |
Neovascular Glaucoma | |
0 | 0 |
*Reported as serious.
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|
Death of Unknown Cause | 0 | 0 |
Nonfatal Hemorrhagic Stroke | 0 | 0.8% (1) |
Nonfatal Ischemic Stroke | 0 | 0 |
Nonfatal Myocardial Infarction | 0.8% (1) | 0 |
Vascular Death | 0.8% (1)† | 0 |
LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|---|
ADVERSE EVENTS, % (n) |
Death of Unknown Cause | |
0 | 0 |
Nonfatal Hemorrhagic Stroke | |
0 | 0.8% (1) |
Nonfatal Ischemic Stroke | |
0 | 0 |
Nonfatal Myocardial Infarction | |
0.8% (1) | 0 |
Vascular Death | |
0.8% (1)† | 0 |
†Reported as fatal hemmorhagic stroke.
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|
Conjunctival Hemorrhage | 54.6% (71) | 42.0% (55) |
Eye Pain | 16.2% (21) | 14.5% (19) |
Maculopathy | 10.0% (13) | 6.9% (9) |
Retinal Depigmentation | 10.8% (14) | 3.8% (5) |
Retinal Exudates | 24.6% (32) | 13.7% (18) |
Retinal Hemorrhage | 14.6% (19) | 12.2% (16) |
Retinal Vascular Disorder | 11.5% (15) | 6.1% (8) |
LUCENTIS 0.5 mg (n=130) | SHAM (n=131) |
---|---|
ADVERSE EVENTS, % (n) |
Conjunctival Hemorrhage | |
54.6% (71) | 42.0% (55) |
Eye Pain | |
16.2% (21) | 14.5% (19) |
Maculopathy | |
10.0% (13) | 6.9% (9) |
Retinal Depigmentation | |
10.8% (14) | 3.8% (5) |
Retinal Exudates | |
24.6% (32) | 13.7% (18) |
Retinal Hemorrhage | |
14.6% (19) | 12.2% (16) |
Retinal Vascular Disorder | |
11.5% (15) | 6.1% (8) |
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).2
In CRUISE, patients with macular edema following central RVO received monthly LUCENTIS 0.3 or 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 months4
CRUISE: Select safety through 6 months3,4
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|
Any Intraocular Inflammation Event (Iridocyclitis, Iritis, Vitritis) | 1.6% (2)§ | 3.9% (5) |
Cataract | 1.6% (2) | 0 |
Endophthalmitis | 0 | 0 |
Intraocular Pressure Increased | 7.8% (10) | 3.1% (4) |
Iris Neovascularization | 0.8% (1)ll | 7.0% (9) |
Neovascular Glaucoma | 0 | 1.6% (2) |
LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|---|
ADVERSE EVENTS, % (n) |
Any Intraocular Inflammation Event (Iridocyclitis, Iritis, Vitritis) | |
1.6% (2)§ | 3.9% (5) |
Cataract | |
1.6% (2) | 0 |
Endophthalmitis | |
0 | 0 |
Intraocular Pressure Increased | |
7.8% (10) | 3.1% (4) |
Iris Neovascularization | |
0.8% (1)ll | 7.0% (9) |
Neovascular Glaucoma | |
0 | 1.6% (2) |
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|
Death of Unknown Cause | 0 | 0 |
Nonfatal Hemorrhagic Stroke | 0 | 0 |
Nonfatal Ischemic Stroke | 0 | 0 |
Nonfatal Myocardial Infarction | 0.8% (1) | 0.8% (1) |
Vascular Death | 0 | 0 |
LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|---|
ADVERSE EVENTS, % (n) |
Death of Unknown Cause | |
0 | 0 |
Nonfatal Hemorrhagic Stroke | |
0 | 0 |
Nonfatal Ischemic Stroke | |
0 | 0 |
Nonfatal Myocardial Infarction | |
0.8% (1) | 0.8% (1) |
Vascular Death | |
0 | 0 |
ADVERSE EVENTS, % (n) | LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|
Conjunctival Hemorrhage | 41.1% (53) | 32.6% (42) |
Eye Irritation | 7.0% (9) | 4.7% (6) |
Eye Pain | 18.6% (24) | 10.1% (13) |
Foreign Body Sensation in Eyes | 7.0% (9) | 3.9% (5) |
Maculopathy | 11.6% (15) | 7.8% (10) |
Nasopharyngitis | 5.4% (7) | 2.3% (3) |
Ocular Vascular Disorder | 5.4% (7) | 0 |
Retinal Exudates | 17.1% (22) | 11.6% (15) |
Retinal Hemorrhage | 7.8% (10) | 10.1% (13) |
Retinal Vascular Disorder | 13.2% (17) | 12.4% (16) |
Vitreous Floaters | 9.3% (12) | 3.9% (5) |
Vitreous Hemorrhage | 5.4% (7) | 7.0% (9) |
LUCENTIS 0.5 mg (n=129) | SHAM (n=129) |
---|---|
ADVERSE EVENTS, % (n) |
Conjunctival Hemorrhage | |
41.1% (53) | 32.6% (42) |
Eye Irritation | |
7.0% (9) | 4.7% (6) |
Eye Pain | |
18.6% (24) | 10.1% (13) |
Foreign Body Sensation in Eyes | |
7.0% (9) | 3.9% (5) |
Maculopathy | |
11.6% (15) | 7.8% (10) |
Nasopharyngitis | |
5.4% (7) | 2.3% (3) |
Ocular Vascular Disorder | |
5.4% (7) | 0 |
Retinal Exudates | |
17.1% (22) | 11.6% (15) |
Retinal Hemorrhage | |
7.8% (10) | 10.1% (13) |
Retinal Vascular Disorder | |
13.2% (17) | 12.4% (16) |
Vitreous Floaters | |
9.3% (12) | 3.9% (5) |
Vitreous Hemorrhage | |
5.4% (7) | 7.0% (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.4
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
Campochiaro PA, et al; BRAVO Investigators. Ophthalmology. 2010;117:1102-1112.
Campochiaro PA, et al; BRAVO Investigators. Ophthalmology. 2010;117:1102-1112.
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
Brown DM, et al; CRUISE Investigators. Ophthalmology. 2010;117:1124-1133.
Brown DM, et al; CRUISE Investigators. Ophthalmology. 2010;117:1124-1133.
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