("Source: Eye World")
Highlights from ARVO 2011
This year's conference boasted more than 5,000 presentations and posters
The annual Association for Research in Vision and Ophthalmology meeting was highlighted this year by an in-depth discussion of the recent Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) 1-year results. Study co-chair Daniel F. Martin, M.D., Cole Eye Institute, Cleveland, stressed that although the study was fully funded by the National Eye Institute, drug costs were not considered.
"When we submitted the protocol, Lucentis (ranibizumab, Genentech, South San Francisco, Calif.) had not even been approved, so we could not know what the pricing strategy was going to be," he said to a standing-room only crowd of more than 1,500.
Because a loss or gain of a single letter was not deemed clinically relevant, the CATT group eventually settled on five letter gains/losses as being statistically and clinically significant (one line gain/loss), said co-chair Maureen Maguire, Ph.D., Scheie Eye Institute, Philadelphia. Given monthly, Avastin (bevacizumab, Genentech) used off-label helped patients gain 8.0 letters, while Lucentis helped them gain 8.5 letters. When dosed on a PRN schedule, Avastin showed a 5.9 letter gain and Lucentis a 6.8 letter gain. Avastin dosed monthly was equivalent to Lucentis dosed PRN, Lucentis dosed monthly was equivalent to Lucentis dosed PRN, Dr. Martin said, but neither Avastin nor Lucentis dosed monthly were equivalent to Avastin dosed PRN.
"Those latter results did not show non-inferiority," Dr. Martin said. "What we can say is that the findings are inconclusive at this time." As-needed dosing resulted in about four fewer injections during the first year than in the monthly group, but he added vigilance by study centers to ensure subject compliance may not be as easy to accomplish in real-world settings where patients have to pay for treatment.
The CATT study enrolled 1,208 patients across 44 centers; 23 patients and one center were excluded from study results because of protocol breach, Dr. Maguire said.
Glaucoma
Phase III data showed once-daily tafluprost as comparable to twice-daily timolol in 643 patients with open-angle glaucoma or ocular hypertension. Baseline IOPs ranged from 23.8-26.1 mm Hg in patients treated with tafluprost and 23.5-26.0 mm Hg in those treated with timolol. At the 12-week end of the study visit, IOPs ranged from 17.4-18.6 mm Hg in the tafluprost group and 17.9-18.5 mm Hg in the timolol group. Treatment effects were seen as early as week 2.
A literature review compared the newer diagnostic imaging tools (optical coherence tomography [OCT, Carl Zeiss Meditec, Dublin, Calif.], Heidelberg Retina Tomograph [HRT, Heidelberg Engineering, Carlsbad, Calif.], and glaucoma diagnosis [GDx, Carl Zeiss Meditec)] to white-on-white perimetry in their ability to detect glaucoma. Presenters with the Ivey Eye Institute, London, Ontario, said the data "favors GDx and OCT over HRT for diagnostic accuracy in glaucoma compared to a gold standard of white-on-white visual field." The greatest accuracy, however, was with blue-on-yellow perimetry, said Francie F. Si, M.D.
Clear lens extraction is more effective than laser peripheral iridotomy (LPI) as a first-line treatment for angle-closure glaucoma, according to Qi N. Cui, Ph.D., University of Rochester, N.Y., and colleagues. Provided the probability of a trabeculectomy following LPI exceeds approximately 6.4%, clear lens extraction yields fewer severe adverse outcomes (i.e., endophthalmitis) over 5 years. The incremental cost effectiveness ratio of LPI as opposed to lens extraction suggests an incremental cost effectiveness ratio of over $5 million per additional quality-adjusted life years saved, she said.
Ocular surface and cornea
The average endothelial cell loss following Descemet's stripping automated endothelial keratoplasty in patients with Fuchs' endothelial dystrophy "remains relatively stable up to 2 years post-operatively," according to a poster from Jennifer Y. Li, M.D., Devers Eye Institute, Portland, Ore. After the second year, there is a "gradual decline" in endothelial cell loss through year 4.
In a Phase II dry eye trial, subjects receiving SAR 1118 (SARCode, Brisbane, Calif.) demonstrated a reduction in corneal staining, increased tear production, and improved visual-related function as compared to placebo, according to the company. SAR 1118 is a first-in-class, topically administered small molecule integrin antagonist that inhibits T-cell mediated inflammation. In the randomized, placebo-controlled, multicenter trial, which included 230 subjects with dry eye, SAR 1118 demonstrated dose-dependent significant improvements (P<.05) in inferior corneal staining over 12 weeks.
Refractive and cataract
The occurrence of rhegmatogenous retinal detachment (RRD) after LASIK surgery for the correction of myopia is infrequent (0.19%), according to J. Fernando Arevalo, Clinica Oftal Centro Caracas, Venezuela, and colleagues. They retrospectively analyzed charts of 22,296 myopic eyes post-LASIK. Only 22 eyes (19 patients) developed retinal detachment, between 1 month and 13 years after LASIK. Those with RRD had baseline myopia from –1.5 D to –9.75 D.
Zinc found in the lenses of patients with Alzheimer's and Down syndrome supports the theory that Alzheimer's is a systemic disorder. Accumulation of amyloid-? in the brain is a principal feature of Alzheimer's disease and Down syndrome. In this study, Lee E.
Goldstein, M.D., Boston University, and colleagues analyzed human Alzheimer's and Down syndrome lenses and identified co-localized zinc and amyloid-? in the same cytosolic compartments of lens fiber cells. The researchers said these data are the first to establish an Alzheimer's-linked amyloid pathology outside the brain and may ultimately "pave the way for development of novel ophthalmic technology for early Alzheimer's detection and diagnosis."
Retina
A total of 6,734 individuals undergoing anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD) were compared with the same number of individuals with neovascular AMD who did not undergo anti-VEGF treatment. The anti-VEGF group had an 87.9% higher risk of severe ocular complications overall and 2.6% increased risk per injection, said Shelley Day, M.D., Duke University, Durham, N.C. There were 38 cases of endophthalmitis in the anti-VEGF group compared with six in the control group; similarly, twice as many people in the anti-VEGF group had a vitreous hemorrhage (1.8%) compared to the control group (0.94%).
"Individuals with anti-VEGF injections had twice the risk of serious ocular complications, and a
diagnosis of proliferative diabetic retinopathy doubled the risk of complications," she said. "A previous history of glaucoma surgery increased the risk by 70%." The group defined glaucoma surgery as uncomplicated trabeculectomy or tube implants.
Population-based studies
The duration of diabetes and poor glycemic and blood pressure control are strongly associated with a higher prevalence in diabetic retinopathy, proliferative diabetic retinopathy, diabetic macular edema, and vision-threatening diabetic retinopathy, highlighting the "substantial public health impact of diabetes." The results are based on a population-based study of pooled data from general and diabetic populations in the United States, Australia, Europe, and Asia.
A longitudinal study funded by the National Institutes of Health (NIH) suggested the ability to read, recognize faces, or find a street sign will deteriorate significantly over time for adults with age-related geographic atrophy of the macula (GA). A questionnaire was completed at baseline and annually by subjects enrolled in the NIH-funded prospective natural history study of geographic atrophy from AMD from 1992-2000. The reports showed that subjects' difficulty in reading, haziness, face recognition, and finding signs worsened with worse visual acuity and with larger GA area at baseline. Longitudinally, reading and face recognition deteriorated significantly.
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