From the editors of Review of Ophthalmology:
OCTOBER IS HALLOWEEN SAFETY MONTH
In this issue: (click heading to view article)
Effects of Intravitreal Anti-VEGF Therapy on Glaucoma-like Progression in Susceptible Eyes
Researchers studied whether repeated intravitreal anti-vascular endothelial growth factor injections accelerated structural and functional glaucomatous changes in eyes with preexisting glaucoma or ocular hypertension.
The retrospective, observational study of injected and non-injected fellow eyes included 28 patients with preexisting glaucoma or OHT who received six or more unilateral anti-VEGF injections for concurrent neovascular retinal disease. Primary outcome measures were rate of visual field loss in dB/year, rate of change in retinal nerve fiber layer thickness in microns/year, and need for additional glaucoma medications, surgery or laser. Here were some of the findings:
• The number of eyes requiring additional glaucoma surgery or laser was eight of 28 (28.6 percent) for the injected group and two of 28 (7.1 percent) for the non-injected group.
• A significantly greater proportion of injected eyes required invasive glaucoma intervention (p=
• The average rate of decline in mean deviation and change in pattern standard deviation were both significantly greater in injected eyes (p=
• The estimated mean rate of global RNFL change was -4.27 µm/y for the injected group and -1.17 µm/y for the non-injected group, and was significant only for injected eyes (p=
• Only the superior quadrant exhibited thinning that was significantly different between groups (p=
Researchers reported that intravitreal injections were associated with accelerated functional and structural glaucoma-like change in susceptible eyes. They suggested that clinicians should assess the need for glaucoma medications or other interventions over the course of anti-VEGF therapy.
SOURCE: Du J, Patrie JT, Prum BE, et al. Effects of intravitreal Anti-VEGF therapy on glaucoma-like progression in susceptible eyes. J Glaucoma 2019; Oct 17. [Epub ahead of print].
Impact of Integrated Multiple Image Averaging on OCTA Image Quality and Quantitative Parameters
Investigators wrote that multiple image averaging (MIA) is a new approach to improve OCT angiography imaging. They aimed to analyze the impact of MIA on image quality and quantitative OCTA parameters.
They prospectively enrolled 20 eyes from 20 healthy volunteers (55.65 ±14.8 years). They performed imaging using two commercially available OCTA devices (Canon OCT HS-100, Optovue AngioVue) with a uniform imaging protocol. Each participant had two single scans of the macula (3 × 3 mm, Canon and Optovue) as well as five continuous single-scan imaging procedures (3 × 3 mm each) using the Canon device. Three out of five of these images with highest quality were manually chosen and then automatically processed by the Canon device using MIA.
Investigators analyzed the superficial retinal plexus of the single scans and of MIA images with regard to the device’s own image quality scores (IQS), peak signal-to-noise ratio (PSNR), the size of the foveolar avascular zone (FAZ) and vessel density (VD). They recorded image acquisition times. And they compared the parameters between the devices and the different imaging protocols. Here were some of the findings:
• Average acquisition time was significantly higher for the MIA compared with the single measurements (29.09 ±10.19 seconds (MIA) vs. 5.56 ±2.17 seconds (Canon single scan) vs. 20.28 ± 6.81 seconds (Optovue) [p<0.001]).
• IQS showed no significant differences between the devices and between the recording protocols.
• PSNR was 12.38 ±0.20 (Canon single scan), 13.01 ±0.36 (Canon MIA) and 14.34 ±0.60 (Optovue) (p<0.001 between the groups).
• The mean FAZ area in Canon single scans was 0.29 ±0.06 mm2, 0.27 ±0.07 mm2 using MIA and 0.27 ± 0.08 mm2 using the Optovue device.
• No significant difference was found between mean FAZ measurements before and after averaging (Canon single scan vs. MIA, p=0.168).
• The VD of the parafoveal area using MIA was significantly lower compared with both single scans (p<0.001).
Investigators concluded that MIA could improve PSNR, but it also reduced imaging speed and significantly affected VD measurements. Therefore, they added that when comparing OCTA data, the use of uniform imaging protocols would be required.
SOURCE: Lauermann JL, Xu Y, Heiduschka P, et al. Impact of integrated multiple image averaging on OCT angiography image quality and quantitative parameters. Graefes Arch Clin Exp Ophthalmol 2019; Oct 19. [Epub ahead of print].
Association Between Early Sjögren’s Markers and Symptoms & Signs of Dry Eye
Animal models suggest that early markers of Sjögren’s syndrome (EMS)—antibodies against salivary protein 1, parotid secretory protein and carbonic anhydrase 6 (CA6)—are more accurate signals of early Sjögren’s when compared with classic markers (anti-Ro and anti-La). To further understand the relationship between EMS and dry eye, scientists compared symptoms and signs of DE in subjects who tested positive vs. negative for EMS.
In the cross-sectional study, patients at the Miami Veterans Affairs Eye Clinic who were tested for EMS underwent a standard ocular surface exam. Indications for EMS testing included DE symptoms in combination with dry-mouth symptoms, low tear production, corneal staining or a Sjögren’s disease-associated autoimmune disease. Statistical tests performed were the χ2
test, Fisher exact test, independent sample T test and Spearman correlation. Here were some of the findings:
• Seventy-three percent of 44 patients tested positive for one or more EMS.
• CA6 IgG was most frequently elevated, followed by CA6 IgM and parotid secretory protein IgG.
• EMS-positive (n=32, 100 percent) vs. EMS-negative subjects (n=9, 75 percent) were more likely to escalate DE treatment past artificial tears to topical cyclosporine (p=
• No demographic or comorbidity differences were found between EMS-positive and -negative subjects, and marker levels didn’t correlate with more severe tear film measures.
Scientists found that most individuals with DE tested positive for one or more EMS antibodies. They added that future studies would be needed to understand how to incorporate EMS data into the care of an individual with DE.
SOURCE: Hubschman S, Rojas M, Kalavar M, et al. Association between early Sjögren markers and symptoms and signs of dry eye. Cornea 2019; Oct 16. [Epub ahead of print].
Outcomes After Anti-VEGF for ME Due to CRVO or HRVO
Two-year outcomes were reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor therapy for macular edema due to central retinal vein occlusion or hemiretinal vein occlusion from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial.
Researchers evaluated outcomes one year after cessation of the SCORE2 treatment schedule. In the secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between Sept. 17, 2014, and Nov. 18, 2015. Data for the analyses were frozen on Sept. 13, 2018.
SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion and underwent assessment at month 24. Main outcomes and measures included visual acuity letter score (VALS) and central subfield thickness (CST) on spectral-domain optical coherence tomography. Here were some of the findings:
• Among 362 participants randomized to aflibercept or bevacizumab, 65.2 percent (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12) years; 53.8 percent male).
• The mean (SD) VALS improved from baseline to 12 months by 21.6 (14.5) in the aflibercept group compared with 21.9 (16.6) in the bevacizumab group (difference, -0.3; 99 percent CI, -5.6 to 4.9), then worsened from those values by a mean (SD) VALS of 7.6 (17.5) in the aflibercept group and 7.5 (14.5) in the bevacizumab group (difference, -0.1; 99 percent CI, -5.6 to 5.3) at month 24.
• The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference: 26 μm; 99 percent CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference, 10 μm; 99 percent CI, -58 to 78 μm) at month 24.
Researchers wrote that no differences in VALS or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. They added that caution in interpretation is needed because of loss to follow-up. In both groups, researchers wrote, VALS and CST improved through month 12 and then worsened somewhat during the second year, when treatment was at investigator discretion. Researchers wrote further that this analysis suggested that CRVO and HRVO warrant close monitoring and treatment as needed over at least two years to optimize outcomes in eyes treated with anti-VEGF therapy.
Source: Scott IU, Oden NL, VanVeldhuisen PC, et al. Month 24 outcomes after treatment initiation with anti-vascular endothelial growth factor therapy for macular edema due to central retinal or hemiretinal vein occlusion: SCORE2 Report 10: A secondary analysis of the SCORE2 randomized clinical trial.
JAMA Ophthalmol 2019; Oct 10. [Epub ahead of print].
Bausch Health Licenses Clearside Biomedical's Xipere
Bausch Health Companies announced that an affiliate of Bausch Health acquired an exclusive license for the commercialization and development of Xipere (triamcinolone acetonide suprachoroidal injectable suspension) in the United States and Canada. Xipere is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector that’s being investigated as a targeted treatment of macular edema associated with uveitis. Read more.
B+L Introduces PreserVision AREDS 2 Formula Minigel Eye Vitamins
Bausch + Lomb announced the U.S. launch of PreserVision AREDS 2 Formula minigel eye vitamins, which will replace the currently offered PreserVision AREDS 2 Formula soft gels, offering patients an easier-to-swallow option. The vitamins contain the exact nutrient formula recommended by the National Eye Institute for people with moderate to advanced age-related macular degeneration following the landmark AREDS2 clinical study. PreserVision AREDS 2 minigel eye vitamins are available at major retailers nationwide. Learn more.
Aerie Completes Enrollment in the Phase II Trial of AR-1105
Aerie Pharmaceuticals announced that patient enrollment in its Phase II clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion was completed several weeks ahead of schedule. AR-1105 is an investigational sustained-release, bio-erodible intravitreal implant containing dexamethasone. The Phase II study, conducted at 19 centers in the United States, had an enrollment target of 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the implant. Safety and efficacy will be evaluated at six months. Read more.
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