#########
Volume 12, Number 49
Monday, December 3, 2012
#########



In this issue: (click heading to view article)
#########
######### Topographical Distribution of Retinal and Optic Disc Neovascularization in Early Stages of Proliferative DR

#########
######### Macular Epiretinal Brachytherapy in Treated AMD
#########
######### ELM Status and VA in DME
#########
######### Link Between Fuchs Endothelial Corneal Dystrophy Severity and Glaucoma and/or OH
#########
######### Briefly

 

 

http://www.ecoxoma.com/




Topographical Distribution of Retinal and Optic Disc Neovascularization in Early Stages of Proliferative DR

In Norway, investigators sought to analyze the topography of proliferative diabetic retinopathy (DR) and visualize the distribution of neovascularization of the optic disc (NVD) and elsewhere in the retina (NVE).

They included 174 eyes of 106 patients with early PDR in their study. The investigators converted data on the size and location of 391 NVE and 73 NVD into a database of two-dimensional retinal and optic disc charts. They then plotted the geometric centers of the neovascular lesions into corresponding areas of the charts and visualized the topographical distributions of the NVE and NVD by merging the charts and displaying the number of overlapping lesions on color-coded contour maps.

The investigators located 141 (36%) NVE in the temporal and 250 (64%) in the nasal hemisphere (p<0.001). They noted that the distribution of the NVD in the temporal and the nasal half of the optic disc was 46 (63%) and 27 (37%), respectively (p=0.03). They also reported that NVE in type 1 diabetes were located significantly farther from the fovea and optic disc and were more numerous and larger than in type 2 diabetes. Moreover, they found that the number and diameter of the NVE were also significantly higher when the time from the last examination prior to the appearance of PDR exceeded 12 months.

The majority of NVE are located inferonasal to the optic disc and along the superior vascular arcades, while NVD have a predilection for the upper temporal disc rim. More extensive PDR is found in patients with type 1 diabetes and those with examination intervals longer than one year.

SOURCE: Jansson RW, Froystein T, Krohn J. Topographical distribution of retinal and optic disc neovascularization in early stages of proliferative diabetic retinopathy. Invest Ophthalmol Vis Sci. 2012; Nov 20. [Epub ahead of print].



http://www.revophth.com/ParkCity2013







Macular Epiretinal Brachytherapy in Treated AMD

Here, the optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) results of the Macular Epiretinal Brachytherapy in Treated Age-Related Macular Degeneration study are reported.

A total of 53 eyes of 53 participants with chronic, active neovascular age-related macular degeneration (AMD) requiring frequent anti-vascular endothelial growth factor (anti-VEGF) retreatment were included in this prospective, multicenter, interventional, noncontrolled clinical trial. They underwent pars plana vitrectomy with a single 24-gray dose of epimacular brachytherapy (EMB) delivered with an intraocular handheld cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. They underwent FFA at baseline, month 1 and month 12 and OCT at baseline and then monthly for 12 months. The FFA and OCT images were evaluated by independent, central reading facilities. Change in OCT centerpoint thickness and angiographic lesion size 12 months after EMB was the main outcome measure.

It was reported that mean centerpoint thickness increased by 50 µm, from 186 µm to 236 µm (p=0.292), but 70% of participants had an increase of less than the mean, with a median increase of only 1.8 µm. It was also noted that the FFA total lesion size increased slightly by 0.79 mm², from 14.69 to 15.48 mm² (p=0.710). Total choroidal neovascularization (CNV) area increased by 1.17 mm², from 12.94 to 14.12 mm² (p=0.556). The classic CNV area decreased substantially by 3.70 mm², from 3.90 to 0.20 mm² (p<0.01). Predominantly classic lesions showed the greatest response, with mean Early Treatment Diabetic Retinopathy Study visual acuity improving by 1.5 letters (versus −4.0 for all participants combined); mean centerpoint thickness decreased by 43 µm (p=0.875). The angiographic and OCT response did not correlate with lesion size at baseline.

To conclude, in chronic, active, neovascular AMD, EMB is associated with nonsignificant changes in centerpoint thickness and FFA total lesion size over 12 months.

SOURCE: Petrarca R, Dugel PU, Nau J, et al. Macular epiretinal brachytherapy in treated age-related macular degeneration (MERITAGE Study). Ophthalmology. 2012;Nov 23. [Epub ahead of print].

http://www.revophth.com/Update2013







ELM Status and VA in DME

Japanese investigators evaluated the association between the foveal external limiting membrane (ELM) status and visual acuity (VA) in diabetic macular edema (DME) and found that, in DME, the ELM status may be as closely related to VA as the IS/OS status.

They retrospectively reviewed the spectral domain optical coherence tomography images of 127 eyes from 127 patients with DME and evaluated the correlation between the logarithm of the minimal angle of resolution (logMAR) VA and the statuses of the foveal ELM, inner segment/outer segment (IS/OS) and cone outer segment tips (COST); foveal macular thickness (FMT); and presence or absence of hard exudates (HE), serous retinal detachment (SRD) and vitreous adhesion. They then classified the integrity of the ELM, IS/OS and COST into three categories (absent, disrupted and complete).

According to the study investigators, there was a strong correlation between VA and the statuses of the ELM (r=0.699, p<0.001), IS/OS (r=0.716, p<0.001) and COST (r=0.471, p<0.001). They found no correlation between FMT and logMAR VA (r=–0.036, p=0.687). However, when they analyzed the correlation between FMT and VA by dividing patients into those with FMT ≤250 µm and those with FMT >250 µm, there was a positive correlation between FMT and VA in eyes with FMT ≤250 μm (r=–0.601, p<0.0001) and a negative correlation in eyes with FMT>250 µm (r=0.290, p<0.01). Other factors HE, SRD and vitreous adhesion did not correlate with VA.

SOURCE: Ito S, Miyamoto N, Ishida K, Kurimoto Y. Association between external limiting membrane status and visual acuity in diabetic macular edema. Br J Ophthalmol. Nov 21. [Epub ahead of print].






Link Between Fuchs Endothelial Corneal Dystrophy Severity and Glaucoma and/or OH

The authors of the following study investigated whether Fuchs endothelial corneal dystrophy (FECD) severity is associated with glaucoma and/or ocular hypertension (G/OHTN).

They examined a subset of eyes (n=1610) from the FECD Genetics Multi-Center Study to estimate the association between FECD severity (grades 0-6 based on guttae confluence) and G/OHTN. Logistic regression models that accounted for the correlation between eyes and adjusted for age, sex, central corneal thickness, IOP, presence of diabetes, and time of day of the initial evaluation were fit.

A total of 107 eyes (6.6%) had G/OHTN based on the study definition. The prevalence of G/OHTN in the control group was 6.0% and was lower in index cases with an FECD grade of 1 through 3 and family members with a grade of 0 or 1 through 3 (0.0% and 2.1%, respectively), but higher in index cases and family members with a grade of 4 through 6 (11.2% and 8.5%, respectively). Adjusting for covariates, eyes with a grade of 4 through 6 were more likely to have concurrent G/OHTN than eyes with no FECD (index cases vs controls: odds ratio [OR]=2.10, p=.04; affected vs unaffected family members: OR=7.06, p=.07), the authors reported. They also found that age (OR=1.06 per 1-year increase, p<.001) and IOP (OR=1.15 per 1-mm Hg increase, p<.001) were associated with an increased prevalence of G/OHTN. Sex, diabetes, time of day of evaluation and central corneal thickness were not associated with the prevalence of G/OHTN (p≥.15).

In conclusion, G/OHTN occurs more often in eyes with severe FECD compared with unaffected eyes. Therefore, it may be beneficial to monitor for the development of glaucoma in these patients.

SOURCE: Nagarsheth M, Singh A, Schmotzer B, et al; for the Fuchs’ Genetics Multi-Center Study Group. Relationship between Fuchs endothelial corneal dystrophy severity and glaucoma and/or ocular hypertension. Arch Ophthalmol. 2012;130(11):1384–1388.




  • KALVISTA WINS GRANT TO FURTHER DEVELOP DME TREATMENT. KalVista Pharmaceuticals has won a (£2.4 million ($3,841,680) grant from the Technology Strategy Board under the UK Government's £180 million Biomedical Catalyst funding initiative for research and development in the life sciences. The company plans to use the new funding to accelerate the development of an oral plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME). Plasma kallikrein is an enzyme recently shown to be elevated in the vitreous of DME patients and to cause excessive vascular permeability in models of diabetes, suggesting its potential as a novel vascular endothelial growth factor (VEGF)-independent target for the treatment of DME. The Biomedical Catalyst grant will allow KalVista to complement preclinical development of oral plasma kallikrein inhibitors identified by the company and prepare a drug candidate ready for Phase I clinical development. Click here for additional details.
  • PHASE III CLINICAL STUDY OF BROMSITE FULLY ENROLLED. InSite Vision Incorporated recently announced that patient enrollment has been completed in the first Phase III clinical trial of BromSite (ISV-303) for the reduction of pain and inflammation following cataract surgery. BromSite combines a low dose (0.075%) of the NSAID bromfenac with InSite Vision's DuraSite drug delivery technology. This study is the first of two Phase III studies in support of BromSite's regulatory submissions and has enrolled more than 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. The primary endpoint is the reduction of pain and inflammation after surgery. Currently, 80 patients remain on-study and InSite Vision expects that the Phase III BromSite clinical trial will be complete and top-line data available in early 2013. Read more about the study at www.insitevision.com.
  • OKUVISION GMBH INITIATES MULTICENTER POST-MARKET STUDY. In a recent press release, Okuvision GmbH has announced the start of a multicenter, post-market study for the company's CE-marked OkuStim treatment, which, according to Okuvision, represents an advance in the treatment of retinitis pigmentosa (RP), providing patients with a clinical option that has been shown to delay the progress of RP-related blindness. The new post-market study, called TESOLA, is currently under way and enrolling patients at six sites in Germany, Norway and Denmark. Four additional sites in Germany and the UK are working with their internal regulatory boards to gain approval to become active study sites within the coming weeks. According to Okuvision, the TESOLA study will accrue 100 patients who will receive 150% of the perceived threshold level of OkuStim therapy for 30 minutes once a week over a six-month period. After the physicians determine each individual patient's threshold, patients will administer the weekly transcorneal electrical stimulation therapy in their own homes.
  • ALCON PURCHASES SENSOMOTORIC INSTRUMENTS' OPHTHALMIC DIVISION. In a recent news release, SensoMotoric Instruments GmbH (SMI) announced that it has sold its Ophthalmic Division to Alcon, providing Alcon with SMI's ocular surgical guidance technology. Alcon plans to integrate the newly acquired ocular surgical guidance technology into its existing global cataract portfolio.
  • ACCUTOME PUTS SPOTLIGHT ON NEW CONNECT PLATFORM. Accutome will unveil its Connect platform diagnostic ultrasound package at booth 212 during the January 19–25 Hawaiian Eye 2013 show. The Connect platform is a portable, interchangeable and upgradeable ophthalmic system that allows eye-care professionals to run the company's A-Scan, B-Scan and UBM on a single laptop or PC. It features advanced diagnostic tools while saving valuable space in the office and information produced from the device can be uploaded to electronic medical records. Visit Accutome's website to learn more.
  • EUROPEAN COMMISSION APPROVES EYLEA INJECTION FOR TREATMENT OF PATIENTS WITH WET AMD. According to Regeneron Pharmaceuticals Inc., the European Commission has approved EYLEA (aflibercept) Injection for the treatment of patients with wet age-related macular degeneration (AMD). Per the European Medicines Agency (EMA) approved Summary of Product Characteristics, EYLEA treatment is initiated with one 2-mg injection per month for three consecutive months, followed by one injection every two months. There is no requirement for monitoring by the physician between injections and after the first 12 months of treatment with EYLEA, the treatment interval may be extended based on visual and anatomic outcomes. In such cases, the frequency of monitoring visits is determined by the treating physician and may be more often than the schedule of injections. For more information, go to the company's website.
  • JETREA SELECTED FOR SINGLE TECHNOLOGY APPRAISAL IN THE UK. ThromboGenics NV has reported that JETREA (ocriplasmin) has been selected to receive a Single Technology Appraisal (STA) from the United Kingdom's National Institute for Health and Clinical Excellence (NICE). The NICE STA process is designed to provide recommendations on the use of new medicines in the National Health Service and the STA is specifically designed to appraise a single product with a single indication, and enables NICE to produce guidance soon after the technology is introduced in the UK. The outcome of the STA is expected later in 2013 following the launch of JETREA in the UK. Meanwhile, the JETREA European Marketing Authorization Application is currently under review by the European Medicines Agency. Read more at http://thrombogenics.com.



Review of Ophthalmology® Online is published by the Professional Publications Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073.

To subscribe to other JMI newsletters or to manage your subscription, click here.

To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address.

To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list.

Click here if you do not want to receive future emails from Review of Ophthalmology Online.

Advertising: For information on advertising in this e-mail newsletter or other creative advertising opportunities with Review of Ophthalmology, please contact publisher Rick Bay, or sales managers James Henne or Michele Barrett.

News: To submit news or contact the editor, send an e-mail, or FAX your news to 610.492.1049