Genentech announced that its Phase III study CRUISE showed Lucentis (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to central retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study.
Earlier this month, Genentech announced that the Phase III study BRAVO showed Lucentis improved vision in patients with macular edema due to branch retinal vein occlusion. Full results from CRUISE and BRAVO will be presented at this month's Retina Congress in
CRUISE evaluated the safety and efficacy profile of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity at six months compared to sham. CRUISE is a multicenter, randomized, double-masked, sham injection–controlled Phase III study, designed to assess the safety and efficacy of Lucentis in macular edema secondary to central-RVO. Patients (n=392) were enrolled at 95 clinical trial sites across the
The 12-month study consists of a six-month, sham-controlled treatment period, followed by a six-month observation period (during which all participants were eligible to receive Lucentis as needed). During the first six-month period, participants received monthly injections of one of two different doses (0.3 mg or 0.5 mg) of Lucentis (n=262) or monthly sham injections (n=130). The study was not designed to compare the two doses of Lucentis. The primary endpoint was the mean change from baseline in best-corrected visual acuity score at six months compared to sham.
Minor Stroke May Be Risk for Field Loss in NTG
The presence of silent cerebral infarct may be an independent risk factor for visual field progression in patients with newly diagnosed normal-tension glaucoma, say researchers at the
The prospective cohort study included 286 eyes from 286 NTG patients: 64 with SCI (SCI+) and 222 without SCI (SCI-). Patients were assigned to groups depending on the presence of SCI as detected by cranial computed tomography scan at baseline. Patients were followed-up at four-month intervals for 36 months for visual field progression as per
There were no significant differences in the baseline intraocular pressures, fluctuation amplitude of pretreatment IOP, baseline visual acuity, vertical cup-to-disc ratio, vertical disc diameter, presenting field indices and central corneal thickness between the two groups. Patients with SCI were significantly older compared with SCI- patients (72.4 vs. 63.2 years; p<0.001). Univariate analyses revealed age, fluctuation amplitude of pretreatment IOP, thinner CCT, presence of disc hemorrhage, systemic hypertension, arrhythmia, and SCI were significant for field progression. Silent cerebral infarct was present in 29.6 percent of field-progressed subjects versus 15.3 percent of field-stable subjects (p=0.004). Survival analysis revealed that 65.6 percent of SCI+ versus 45.9 percent of SCI- patients had progressed (p=0.003). Hazards regression analysis showed disc hemorrhage (hazard ratio, 2.28; 95 percent confidence interval, 1.54 to 3.37; p<0.001), SCI (HR, 1.61; CI, 1.09 to 2.36; p=0.016), systemic hypertension (HR, 1.48; CI, 1.04 to 2.10; p=0.029), and CCT (per 30 µm of thinning; HR, 1.35; CI, 1.16 to 1.75; p<0.001) were associated with field progression. Other variables significant in the univariate analysis were not significant in the regression model. The most common location of SCI was at the basal ganglia.
Review Supports DSEK Safety
A review of published literature on safety and outcomes of Descemet's stripping endothelial keratoplasty supports the use of DSEK for the surgical treatment of endothelial diseases of the cornea.
Peer-reviewed literature searches in PubMed and the Cochrane Library through February 2009 yielded 2,118 citations in English-language journals. Of these, 131 articles were selected for possible clinical relevance, of which 34 were determined to be relevant to the assessment objectives.
The most common complications from DSEK among reviewed reports included posterior graft dislocations (mean, 14 percent; range, 0 to 82 percent), followed by endothelial graft rejection (mean, 10 percent; r, 0 to 45 percent), primary graft failure (mean, 5 percent; r, 0 to 29 percent), and iatrogenic glaucoma (mean, 3 percent; r, 0 to 15 percent). Average endothelial cell loss as measured by specular microscopy ranged from 25 to 54 percent, with an average cell loss of 37 percent at six months, and from 24 percent to 61 percent, with an average cell loss of 42 percent at 12 months. The average BCVA (mean, nine months; r, three to 21 months) ranged from 20/34 to 20/66. Postoperative refractive results included induced hyperopia ranging from 0.7 to 1.5 D (mean, 1.1 D), with minimal induced astigmatism ranging from -0.4 to 0.6 D and a mean refractive shift of 0.11 D. A review of graft survival found that clear grafts at one year ranged from 55 to 100 percent (mean, 94 percent).
In terms of surgical risks, complication rates, graft survival (clarity), visual acuity and endothelial cell loss, DSEK appears similar to penetrating keratoplasty, the authors conclude. It seems to be superior to PK in terms of earlier visual recovery, refractive stability, postoperative refractive outcomes, wound and suture-related complications, and intraoperative and late suprachoroidal hemorrhage risk. The most common complications of DSEK do not appear to be detrimental to the ultimate vision recovery in most cases. Long-term endothelial cell survival and the risk of late endothelial rejection were not assessed.
Commission Recommends National Program on Childrens' Vision
School children are being screened at low rates, and those who are screened do not often receive the necessary follow-up and treatment they may require, says a new report from the National Commission on Vision and Health. The report, "Building a Comprehensive Child Vision Care System," found that children without health insurance and those living in poverty are at the greatest risk. Although the majority of states do require some type of vision screening prior to children entering public schools, they often fail to use the best screening tests and to assure important follow-up for those who fail the screening. Deborah Klein Walker, EdD, principal author of the report and past-president of the American Public Health Association, said, "This report finds that vision screenings are not the most effective way to determine vision problems. Screenings missed finding vision conditions in one-third of children with a vision problem, and most of the children who are screened and fail the screening don't receive the follow-up care they need. This, despite the fact that many of the vision problems affecting children can be managed or even eliminated if they receive proper care right away."
Studies indicate that one in four children have an undetected vision problem.
Additionally, a quarter of school-age children suffer from vision problems that could have been addressed or eliminated if appropriate eye assessment programs and follow-up care had been in place when they started school.
Given the data surrounding this public health emergency, the commission recommends agencies at the federal, state and local levels collaborate with academia, business, providers and the public to create a comprehensive child vision care system to ensure all children are assessed for potential eye and vision problems before entering school and throughout the school years. The commission supports a national child vision care system that, among other recommendations:
• includes child vision health care in key legislation at the federal and state levels;
• assures adequate comprehensive coverage of child vision care services by all public and private insurers and payers;
• develops a national set of children's vision guidelines for screening and examinations and assure these guidelines are adopted by all states;
• designs and implements an ongoing data system that monitors prevalence of child vision problems together with access and utilization of child vision care services; and
• develops and facilitates a broad coalition of child-oriented stakeholder groups to work towards the establishment and maintenance of a comprehensive child vision system across the country.
The commission strives to improve the nation's visual health by collaborating with science and health policy experts to ensure informed analysis and policy recommendations in order to prevent blindness, improve vision and eliminate vision health disparities. The multidisciplinary commission publishes consensus reports from its 10-person leadership team, comprising optometrists, ophthalmologists, a dentist, a physician assistant, a state health department chronic disease program specialist, a Medicaid policy specialist, the executive director of the National Medical Association and a CDC disabilities specialist. For information, visit visionandhealth.org.
