Volume 14, Number 33
Monday, August 18, 2014


In this issue: (click heading to view article)
######### Sulodexide in Patients With Nonproliferative Diabetic Retinopathy
######### Predictors of Sustained IOP Elevation in Eyes Given Intravitreal Anti-VEGF Therapy
######### OCT-Defined Changes Preceding the Development of Drusen-Associated Atrophy in AMD
######### How Coenzyme Q10 + Vitamin E Impacts Retinal-Evoked and Cortical-Evoked Responses in Patients With OAG


Sulodexide in Patients With Nonproliferative Diabetic Retinopathy

To evaluate the effectiveness of sulodexide for the treatment of hard exudates in non-proliferative diabetic retinopathy, this randomized, placebo-controlled, multicenter trial involved 130 patients (65 for each group) who had mild-to-moderate NPDR with macular hard exudates.

Participants were given a daily dose of either 50 mg sulodexide or a matching dose of placebo orally for 12 months. Main outcome measure was an improvement in hard exudates defined as a decrease in severity by at least two grades on a 10-grade severity scale. This was evaluated by fundus photography over 12-month period.

It was reported that the sulodexide group showed significantly greater improvement in hard exudates severity than that shown by the placebo group (39.0% vs. 19.3%; chi square, p=0.005). Logistic regression analysis yielded an odds ratio of 2.790 (95% confidence interval, 1.155 to 6.743; p=0.023) for the effect of treatment once adjustments were made for demographic, prognostic and disease confounders. Intention to treat and per-protocol analysis yielded similar results. Sulodexide's safety was comparable to that of the placebo.

To conclude, oral sulodexide therapy over 12 months improved macular hard exudates in patients with mild to moderate NPDR, without leading to detectable adverse events.


SOURCE: Song JH, Chin HS, Kwon OW, et al. Effect of sulodexide in patients with non-proliferative diabetic reinopathy: diabetic retinopathy sulodexide study (DRESS). Graefes Arch Clin Exp Ophthalmol. 2014; Aug 12. [Epub ahead of print].

Predictors of Sustained IOP Elevation in Eyes Given Intravitreal Anti-VEGF Therapy

Investigators designed a cross-sectional physician survey to determine the intravitreal anti-vascular endothelial growth factor injection techniques and preferences within the retinal community and to identify potential factors associated with the development of sustained intraocular pressure elevation in patients treated with intravitreal anti-VEGF therapy for wet age-related macular degeneration.

They surveyed 530 retina specialists spanning both private and academic practices regarding current anti-VEGF intravitreal injection protocols, including the anti-VEGF drug of choice, needle gauge, injection volume, injection technique and self-reported prevalence of sustained IOP elevation. They also performed multivariate logistic regressions to assess the potential influence of these factors on long-term IOP.

According to the investigators, 292 (55%) reported believing that intravitreal anti-VEGF therapy may cause sustained IOP elevation. Of these responses, the most common reported prevalence was 1% to 2% (48%), followed by 3% to 5% (34%). They found no relationship between the frequency of sustained IOP elevation and anti-VEGF drug of choice. Physicians who injected >0.05 cc in <1 second were 5.56 times more likely to observe a high frequency of sustained IOP elevation (p=0.006, 95% CI 1.64 to 18.89).

Based on physician survey data, serial anti-VEGF injections using higher injection volumes with a rapid injection technique may potentially lead to sustained IOP elevation. The underlying mechanism for this complication may be injury to the trabecular meshwork resulting from rapid elevations in IOP. Further investigation of the relationship between injection techniques and sustained IOP elevation in the form of retrospective or prospective clinical studies is warranted.

SOURCE: Yannuzzi NA, Patel SN, Bhavsar KV, et al. Predictors of sustained intraocular pressure elevation in eyes receiving intravitreal anti–vascular endothelial growth factor therapy. Am J Ophthalmol. 2014;158(2):319–327.

OCT-Defined Changes Preceding the Development of Drusen-Associated Atrophy in AMD

The authors of the following longitudinal cross-sectional retrospective observational study sought to characterize the pathological changes preceding the development of drusen-associated atrophy in eyes with age-related macular degeneration using spectral-domain optical coherence tomography.

They longitudinally assessed 181 participants with intermediate AMD in at least one eye (141 unilateral, 40 bilateral). They also analyzed 230 participants with bilateral intermediate AMD (40 longitudinal participants with an additional 190 participants) cross-sectionally.

The study authors performed SD-OCT, color fundus photography, near-infrared reflectance and fundus autofluorescence imaging in all participants at cross-section and every three months for up to 30 months. They examined SD-OCT volume scans for features that portend the development of drusen-associated atrophy, and determined the topography, prevalence and risk factors of these features through cross-sectional analysis. The pathological features on SD-OCT preceding the development of drusen-associated atrophy and the characteristics of these features were the main outcome measures.

Twenty areas from 16 eyes of 16 participants developed drusen-associated atrophy after an average of 20 months (range, eight to 30 months), the authors noted. SD-OCT features unique in these areas included: subsidence of the outer plexiform layer and inner nuclear layer; and development of a hypo-reflective wedge-shaped band within the limits of the OPL. These characteristics were termed nascent geographic atrophy (nGA), describing features that portend the development of drusen-associated atrophy. Cross-sectional examination of participants with bilateral intermediate AMD revealed that independent risk factors for the presence of nGA included the presence of pigmentary changes (odds ratio, 16.84; 95% confidence interval, 2.42 to 117.24) and nGA in the fellow eye (OR, 4.15; 95% CI, 1.12 to 15.34); nGA was present in 21.9% of participants with drusen >125 µm and pigmentary changes in both eyes.

The authors concluded that this study identified pathological changes occurring before the development of drusen-associated atrophy using SD-OCT, which they defined as nGA. Although nGA is undetectable on CFP, it is important for determining the risk of future vision loss in AMD and could be used as an earlier surrogate endpoint in interventional trials targeting the early stages of AMD.

SOURCE: Wu Z, Luu CD, Ayton LN, et al. Optical coherence tomography-defined changes preceding the development of drusen-associated atrophy in age-related macular degeneration. Ophthalmology. 2014;Aug 8. [Epub ahead of print].


How Coenzyme Q10 + Vitamin E Impacts Retinal-Evoked and Cortical-Evoked Responses in Patients With OAG

In the following study, researchers evaluated pattern-evoked retinal and cortical responses [pattern electroretinogram (PERG) and visual-evoked potential, respectively] following treatment with coenzyme Q10 in conjunction with vitamin E in open-angle glaucoma patients. They found that coenzyme Q10 associated with vitamin E administration in OAG shows a beneficial effect on the inner retinal function (PERG improvement) with consequent enhancement of the visual cortical responses (VEP improvement).

To reach this conclusion, they enrolled 43 OAG patients (mean age, 52.5 ± 5.29 y; intraocular pressure <18 mmHg with beta-blocker monotherapy only). At baseline and after six and 12 months, the researchers obtained simultaneous recordings of PERG and VEPs from 22 OAG patients who underwent treatment consisting of coenzyme Q10 and vitamin E (Coqun, b.i.d.) in addition to beta-blocker monotherapy (GC Group), as well as from 21 OAG patients who were only treated with beta-blockers (GP Group).

They discovered that at baseline, IOP, PERG and VEP parameters were similar in both GC and GP groups (analysis of variance, p>0.05). They also noted that after six and 12 months, PERG and VEP response parameters of GP patients were unchanged when compared to baseline. In GC patients, PERG P50 and VEP P100 implicit times were decreased, whereas PERG P50-N95 and VEP N75-P100 amplitudes were increased (p<0.01) when compared to baseline. In the GC Group, the differences in implicit times and amplitudes with respect to baseline were significantly larger (p<0.01) than those recorded in the GP Group. The improvement (12 months minus baseline) of VEP implicit time was significantly correlated with the changes of PERG P50-N95 amplitude (r=–0.66171, p=0.0008) and P50 implicit time (r=0.68364, p=0.00045) over a period of 12 months.

SOURCE: Parisi V, Centofanti M, Gandolfi S, et al. Effects of coenzyme Q10 in conjunction with vitamin E on retinal-evoked and cortical-evoked responses in patients with open-angle glaucoma. J Glaucoma. 2014;23(6):391–404.


  • PHASE II CLINICAL DATA SUPPORTS USE OF SQUALAMINE EYE DROPS (OHR-102) IN RVO. Ohr Pharmaceutical Inc. has announced data supporting the use of squalamine eye drops (OHR-102) in the treatment of macular edema secondary to branch retinal vein occlusion or central retinal vein occlusion. Ohr says the data demonstrated that the combination of topical squalamine eye drops and intravitreal Lucentis led to a mean gain in visual acuity of 20.3 letters and resolution of the foveal edema in 95% of the patients at week 10. The investigator-sponsored study is a single-site, prospective clinical trial in which 20 treatment-naïve patients with macular edema due to RVO (nine with non-ischemic CRVO, eight with BRVO and three with hemi-central RVO) received OHR-102 for the first 10 weeks of treatment, with two injections of Lucentis given at week two and week six.

  • SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION SUBMITTED TO FDA FOR LUCENTIS INDICATION IN DIABETIC RETINOPATHY. Genentech has submitted a supplemental Biologics License Application for Lucentis (ranibizumab injection) to the FDA for the treatment of diabetic retinopathy. According to a press release, the submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for the disease. During these trials, a clinically significant proportion of DR patients treated with Lucentis showed meaningful improvements in their disease at two years compared to patients treated with sham injections (control group). The benefits of Lucentis on the signs of DR were maintained during the third year of treatment.

  • TWO NEW VITRECTOMY TECHNOLOGIES NOW OFFERED BY ALCON. Alcon recently unveiled two vitrectomy technologies designed to help surgeons deliver a higher level of precision and efficiency during retina surgery. The Ultravit High Speed Vitrectomy Probe operates at an ultrahigh-speed of 7,500 cpm, which helps reduce traction that can cause iatrogenic tears and postoperative complications. The probe also features a dual-pneumatic drive that helps enable efficient flow and precise sharing, even at higher cut rates. Alcon also introduced a new portfolio of 27+ series instruments and accessories that are designed to allow surgeons to reduce incision size as well as provide access to small tissue planes with a stiffness experience similar to 25+ instrumentation. Both technologies are available in the United States. Read more here.

  • MAXIMEYES EHR NOW COMPATIBLE WITH VESTRUM HEALTH'S EHR DATA AGGREGATION TECHNOLOGY PLATFORM. According to First Insight Corp., its MaximEyes cloud-based practice management and 2014 Certified EHR software is now compatible with Vestrum Health's EHR data aggregation technology platform. First Insight's president and CEO, Nitin Rai, explains that the company securely uploads a participating physician's de-identified patient data from MaximEyes to the Vestrum Health servers, where it is converted into an easily analyzable format.

  • EUROPEAN COMMISSION APPROVES EYLEA FOR THE TREATMENT OF DME. EYLEA (aflibercept) injection has now been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema. Bayer Healthcare plans to launch the vascular endothelial growth factor inhibitor in DME in the EU this quarter. Visit Regeneron's website for additional details.

  • HAAG-STREIT INTRODUCES NEW LED-POWERED SLIT LAMP. Haag-Streit recently reported the introduction of the BX 900 LED photographer slit lamp, which features ergonomic, one-hand control; standard LED illumination; and EyeSuite imaging. Click here to learn more about the new instrument.

  • LENSFERRY SERVICE SEEKS TO SIMPLIFY CONTACT LENS E-COMMERCE LANDSCAPE. Aiming to provide independent eye-care practitioners with an easy-to-implement method to more effectively enhance their relationship with wearers, as well as drive contact lens category growth, CooperVision Inc., through its subsidiary WebSystem3 LLC, has debuted its LensFerry service. Now in its U.S. beta release, LensFerry allows wearers to quickly and conveniently order replacement contact lenses from any manufacturer via their mobile device, tablet or computer for fast shipment to their homes. The prescribing practice receives the sales revenue as if the lenses had been ordered in-office and all LensFerry communications are customized with the practice's name and/or logo. The service includes contact lenses from all manufacturers at eye-care practitioners' specified prices. The beta launch period is anticipated to take place over the next 90 days, after which, LensFerry is expected to roll out to other U.S. practices, with the potential for select international availability in 2015. Learn more at www.coopervision.com.

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