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Volume 14, Number 7
Monday, February 17, 2014
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FEBRUARY IS AMD/LOW VISION AWARENESS MONTH




In this issue: (click heading to view article)
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######### Exacerbation of Choroidal and RPE Atrophy Following Treatment of Neovascular AMD with Anti-VEGF Therapy
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######### Risk Factors for Optic Disc Hemorrhage
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######### Link Between Disc Margin-to-Fovea-Distance and Central VF Defect in NTG
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######### The Potential Association Between Postmenopausal Hormone Use and POAG
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Exacerbation of Choroidal and RPE Atrophy Following Treatment of Neovascular AMD with Anti-VEGF Therapy

To study the progression of retinal pigment epithelium (RPE) and choroidal atrophy in patients with neovascular age-related macular degeneration (AMD) and to assess for a possible association with the number and type of anti-vascular endothelial growth factor (anti-VEGF) treatments, the authors of this study reviewed patients with neovascular AMD and a minimum of one-year follow-up. They used fellow eyes with nonneovascular AMD as control eyes and determined RPE atrophy area and choroidal thickness using spectral-domain optical coherence tomography (SD-OCT). Additionally, the authors used multivariable regression models for statistical analyses.

A total of 415 eyes were included in the study, with a mean follow-up of 2.2 years. Eyes with neovascular AMD had greater progression of RPE atrophy and choroidal atrophy compared with those with non-neovascular AMD (p<0.001), the authors reported. They noted that progression of RPE atrophy and choroidal atrophy were independently associated with the total number of injections of bevacizumab and ranibizumab (all p values ≤0.001). In the subgroup of 84 eyes with neovascular AMD and without RPE atrophy at baseline, only bevacizumab was associated with the progression of RPE atrophy (p=0.003). This study likely lacked statistical power to detect an association with ranibizumab in this subgroup.

RPE atrophy and choroidal atrophy in neovascular AMD seem to be exacerbated by anti-VEGF treatment. Possible differences between bevacizumab and ranibizumab require further investigation.

SOURCE: Young M, Chui L, Fallah N, et al. Exacerbation of choroidal and retinal pigment epithelial atrophy after anti-vascular endothelial growth factor treatment in neovascular age-related macular degeneration. Retina. 2014; Jan 21. [Epub ahead of print].




Risk Factors for Optic Disc Hemorrhage

In this cohort of a randomized, double-masked, multicenter clinical trial, investigators examined risk factors for disc hemorrhage detection in the Low-pressure Glaucoma Treatment Study.

Included were Low-pressure Glaucoma Treatment Study patients with at least 16 months of follow-up. Exclusion criteria included untreated intraocular pressure (IOP) >21 mmHg, visual field mean deviation worse than –16 dB, or contraindications to study medications. Patients were randomized to topical treatment with timolol 0.5% or brimonidine 0.2% and stereophotographs were independently reviewed by two masked graders searching for disc hemorrhages. The main outcomes investigated were the detection of disc hemorrhage at any time during follow-up and their recurrence. The study investigators analyzed ocular and systemic risk factors for disc hemorrhage detection using Cox proportional hazards model and further tested them for independence in a multivariate model.

They included 253 eyes of 127 subjects (mean age, 64.7 ± 10.9 years; women, 58% European ancestry, 71%) followed for an average (±SD) of 40.6 ± 12 months. They observed that in the multivariable analysis, history of migraine (hazard ratio, HR =5.737, p=0.012), narrower neuroretinal rim width at baseline (HR=2.91, p=0.048), use of systemic beta-blockers (HR=5.585, p=0.036), low mean systolic blood pressure (HR=1.06, p=0.02), and low mean arterial ocular perfusion pressure during follow-up (HR=1.172, p=0.007) were significant and independent risk factors for disc hemorrhage detection. Furthermore, they determined that treatment randomization was not associated with either the occurrence or recurrence of disc hemorrhages.

To conclude, in this cohort of Low-pressure Glaucoma Treatment Study patients, migraine, baseline narrower neuroretinal rim width, low systolic blood pressure and mean arterial ocular perfusion pressure, and use of systemic beta-blockers were risk factors for disc hemorrhage detection. Randomization assignment did not influence the frequency of disc hemorrhage detection.

SOURCE: Furlanetto RL, De Moraes CG, Teng CC, et al; for the Low-pressure Glaucoma Treatment Study Group. Risk factors for optic disc hemorrhage in the Low-pressure Glaucoma Treatment Study. Am J Ophthalmol. 2014;Feb 10. [Epub ahead of print].


Link Between Disc Margin-to-Fovea-Distance and Central VF Defect in NTG

Researchers investigated the relationship between ocular geometric factors, including temporal disc margin to fovea distance (DFD) measured by optic disc stereophotography (ODP) and central visual field (VF) defect, in normal-tension glaucoma (NTG) patients. They concluded that eyes with a shorter DFD should be monitored carefully because central VF involvement appears to be related to shorter DFD in NTG patients with mild VF defects.

This retrospective, single-center, cross-sectional study included 88 eyes of 88 NTG patients with mild VF defects (MD>–6.0 dB). The researchers divided NTG patients into two groups according to VF tests: central VF-invading and central VF-sparing groups. They obtained optic nerve head (ONH) parameters including disc dimensions, peripapillary atrophy (PPA), and DFD by ODP, and measured retinal nerve fiber layer (RNFL) thickness by Stratus optical coherence tomography (OCT).

In the invading group, the researchers discovered that DFD was shorter (3.642 ± 0.401 mm) than in the sparing group (3.877  ± 0.278 mm; p=0.002). They also noted that the sparing group had more vertically oval ONH (p=0.023) and wider temporal PPA width (p=0.031). They also reported that the RNFL thickness in the invading group was thinner in the temporal and inferior quadrants, but thicker in the superior quadrant than that of the sparing group. In a multiple linear regression analysis, DFD was the only geometric factor associated with degree of central VF involvement (p=0.002). The researchers positively correlated DFD with temporal RNFL thickness in the sparing group (r=0.484, p<0.001) but not in the invading group (r=–0.080, p=0.631).

SOURCE: Lee M, Jin H, Ahn J. Relationship between disc margin to fovea distance and central visual field defect in normal tension glaucoma. Graefes Arch Clin Exp Ophthalmol. 2014; 252(2):307–314.





The Potential Association Between Postmenopausal Hormone Use and POAG

Retinal ganglion cells are known to express estrogen receptors and prior studies have suggested an association between postmenopausal hormone (PMH) use and decreased intraocular pressure, suggesting that PMH use may decrease the risk for primary open-angle glaucoma (POAG).

To determine whether the use of three different classes of PMH affects the risk for POAG, this retrospective, longitudinal cohort analysis was performed. It analyzed claims data from women 50 years or older enrolled in a U.S. managed-care plan for at least four years in which enrollees had at least two visits to an eye-care provider during the period 2001 through 2009. Exposure was postmenopausal hormone medications containing estrogen only, estrogen + progesterone, and estrogen + androgen, as captured from outpatient pharmacy claims over a four-year period. Main outcomes and measures were hazard ratios (HRs) for developing incident POAG.

Of 152,163 eligible enrollees, 2,925 (1.9%) developed POAG, and after adjustment for confounding factors, each additional month of use of PMH containing estrogen only was associated with a 0.4% reduced risk for POAG (HR, 0.996 [95% CI, 0.993 to 0.999]; p=0.02). The risk for POAG did not differ with each additional month of use of estrogen + progesterone (HR, 0.994 [95% CI, 0.987 to 1.001]; p=0.08) or estrogen + androgen (HR, 0.999 [95% CI, 0.988 to 1.011]; p=0.89).

In conclusion, use of PMH preparations containing estrogen may help reduce the risk for POAG. If prospective studies confirm the findings of this analysis, novel treatments for this sight-threatening condition may follow.

SOURCE: Newman-Casey PA, Talwar N, Nan B, et al. The potential association between postmenopausal hormone use and primary open-angle glaucoma. JAMA Ophthalmol. 2014;Jan 30. [Epub ahead of print].




  • PHASE II STUDY OF AKB-9778 INITIATED FOR THE TREATMENT OF DME. Aerpio Therapeutics Inc. has dosed the first patient in a Phase II trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak. The randomized, double-masked, double dummy, Phase II study is designed to assess the safety and efficacy of AKB-9778 administered over three months as monotherapy and as an adjunct with ranibizumab in subjects with DME. The primary endpoints of the study are change from baseline in visual acuity and change from baseline in central retinal thickness in the groups treated with AKB-9778 monotherapy and AKB-9778 as an adjunct with ranibizumab compared to ranibiumab monotherapy. It will enroll roughly 120 subjects (40 patients/group) at approximately 35 sites. Read more here.
  • BAUSCH + LOMB INTRODUCES REUSABLE INJECTOR SYSTEM, ROLLS OUT NEW MONTHLY REPLACEMENT SILICONE HYDROGEL CONTACT LENSES. Bausch + Lomb issued two press releases this past week. In one, the company announced the U.S. introduction of BLIS (Bausch + Lomb Injector System), designed exclusively for use with the enVista glistening-free, hydrophobic acrylic intraocular lens (IOL). BLIS, complete with a reusable hand piece and single-use cartridge, allows surgeons safe, controlled delivery of the enVista IOL through unenlarged phaco incisions as small as 2.2 mm. According to Bausch + Lomb, BLIS was developed with the ultimate goal of securely and accurately implanting the enVista IOL while minimizing mishandling, loading errors and damage to the lens. It was also designed to minimize posterior capsular opacification.

    In another press release, the company stated that it has also begun the initial roll-out of its breakthrough monthly Bausch + Lomb Ultra contact lens with MoistureSeal technology. The new lens technology, which as been studied and developed for seven years, combines a breakthrough material with new manufacturing processes to produce a contact lens that breaks the cycle of discomfort for unsurpassed comfort and vision all day. The Bausch + Lomb Ultra contact lenses are now being distributed in select markets with a national roll-out scheduled for spring 2014.
  • ALDEN OPTICAL ACQUIRES FLUORESOFT BRAND. Alden Optical has acquired Fluoresoft-0.35% fluorescent solution from Holles Laboratories Inc. Fluoresoft-0.35% is a high molecular weight fluorescent solution available in the United States and used extensively by specialty contact lens practitioners to evaluate the cornea-to-lens fitting relationship. According to Alden Optical, the compound prevents absorption by soft lens materials, thereby preventing lens staining and is also used to assess epithelial abnormalities due to contact lens wear and during applanation tonometry. Fluoresoft-0.35% is now available in the United States directly from Alden Optical or through any of the current distributors and wholesalers who have traditionally supplied the product. Holles Laboratories intends to pursue distribution in Canada and the European Union by the end of 2014.
  • ILUVIEN ACCEPTED FOR NATIONAL HEALTH SERVICE SCOTLAND. After completing its assessment and review of a simple patient access scheme, the Scottish Medicines Consortium (SMC) has accepted Iluvien for restricted use within the National Health Service (NHS) Scotland. The advice issued by the SMC provides NHS Scotland patients considered insufficiently responsive to available therapies with access to Iluvien, the sustained-release treatment for chronic diabetic macular edema (DME). The advice is restricted to those who have a pseudophakic eye, meaning the eye has already undergone cataract surgery. In addition, retreatment with Iluvien is predicated on a positive response to, and subsequent need for the product.
  • PALANKER RECEIVES 2014 SPIE TRANSLATIONAL RESEARCH AWARD. Topcon Medical Laser Systems Inc. recently announced recognition of Daniel Palanker, PhD, associate professor in the Department of Ophthalmology at Stanford University, by SPIE, the International Society for Optics and Photonics. Dr. Palanker was presented SPIE's 2014 Translational Research Award, recognizing an outstanding contribution in the field of biomedical optics with the potential to change clinical practice and improve the lives of patients. He is a key contributor to the development of Topcon's Endpoint Management and was presented the award for his presentation titled “Non-damaging Laser Therapy of the Macula: Titration Algorithm and Tissue Response,” which highlighted recent findings on the efficacy of photo-thermal stimulation of the retina for the treatment of retinal diseases, confirmed in recent clinical trials.



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