Original articleRanibizumab for Macular Edema following Central Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study
Section snippets
Study Design
The CRUISE was a 6-month phase III, multicenter, randomized, injection-controlled study, with an additional 6 months of follow-up (total 12 months), designed to evaluate efficacy and safety of intraocular injections of ranibizumab in patients with macular edema following CRVO. The study included a 28-day screening period (days −28 to −1); a 6-month treatment period (day 0 to month 6), during which patients received monthly intraocular injections of 0.3 mg or 0.5 mg ranibizumab or sham
Baseline Characteristics and Patient Disposition
Between July 2007 and December 2008, 392 patients were randomized to intraocular injections of 0.3 mg (n = 132) or 0.5 mg (n = 130) ranibizumab or sham injections (n = 130) at 95 centers in the United States. Patient demographics and baseline ocular characteristics were similar across treatment groups (Table 2). The average age of patients was 68 years, and 57% were male. The mean time from diagnosis of CRVO to screening was 3.3 months (median 2 months for each treatment group), with a duration
Discussion
Central retinal vein occlusion is a cause of severe irreversible vision loss in older adults, with an incidence of approximately 30 000 eyes in the United States.27, 28 Patients who present with BCVA <20/40 have a poor natural history. The CRUISE was designed to test the safety and efficacy of intraocular ranibizumab (a potent inhibitor of VEGF A) injected monthly in patients with CRVO. Although the CVOS4 and CRUISE were conducted 20 years apart, and the entry criteria for the 2 studies were
Acknowledgment
Roberta M. Kelly, Genentech, Inc., provided editorial support.
References (30)
Classification of central retinal vein occlusion
Ophthalmology
(1983)- et al.
Interventions for central retinal vein occlusion: an evidence-based systematic review
Ophthalmology
(2007) - et al.
Vascular endothelial growth factor upregulation in human central retinal vein occlusion
Ophthalmology
(1998) - et al.
Ranibizumab for macular edema due to retinal vein occlusions: implication of VEGF as a critical stimulator
Mol Ther
(2008) - et al.
Ranibizumab for the treatment of macular edema associated with perfused central retinal vein occlusions
Ophthalmology
(2008) - et al.
Prospective study of intravitreal ranibizumab as a treatment for decreased visual acuity secondary to central retinal vein occlusion
Am J Ophthalmol
(2009) - et al.
Relative afferent pupillary defect in central retinal vein occlusion
Ophthalmology
(1986) Ophthalmoskopische Notizen3. Apoplexia retinae
Arch Ophthalmologie
(1855)Die spontane Thrombose der Vena centralis des opticus
Albrecht Von Graefes Arch Ophthalmol
(1878)Natural history and clinical management of central retinal vein occlusion
Arch Ophthalmol
(1997)
Risk factors for central retinal vein occlusion
Arch Ophthalmol
Argon laser photocoagulation for macular edema in branch vein occlusion
Am J Ophthalmol
Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1
Arch Ophthalmol
Evaluation of grid pattern photocoagulation for macular edema in central vein occlusionThe Central Vein Occlusion Study Group M report
Ophthalmology
Radial optic neurotomy for central retinal vein occlusion: a retrospective pilot study of 11 consecutive cases
Retina
Cited by (0)
Manuscript no. 2009-1757.
*A list of study investigators (Appendix 1) is available at http://aaojournal.org.
This article contains online-only material. The following should appear online only: CRUISE Investigators (see Appendix 1; available at http://aaojournal.org).
Financial Disclosure(s): The author(s) have made the following disclosure(s): Genentech, Inc., South San Francisco, California, provided support for the study and participated in study design; conducting the study; and data collection, management, and interpretation. Genentech authors Saroj, Rundle, and Gray would like to report Equity Ownership in Roche.
- ⁎
Group members listed online in Appendix 1 (available at http://aaojournal.org).