From the editors of Review of Ophthalmology:
Monday, February 25, 2019
FEBRUARY IS AGE-RELATED MACULAR
DEGENERATION AWARENESS MONTH
In this issue: (click heading to view article)
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Disc Characteristics Associated With High Myopia & Glaucomatous Damage Location in POAG and NTG
Researchers evaluated the disc characteristics in high myopia and the relationships between disc tilt and torsion, and the location of wedge-shaped retinal nerve fiber layer defects in primary open-angle glaucoma and normal-tension glaucoma.
They analyzed the differences in disc properties and clinical characteristics between POAG (n=53) and NTG (n=82), and between high myopic (≤6 diopters, n=77) and non-high myopic (≥-6 diopters, n=58) glaucoma. They assessed the association between disc tilt and torsion and the location of wedge-shaped RNFL defects in POAG and NTG by univariate and multivariate logistic regression analyses. Here were some of the findings:
• In NTG, but not in POAG, high-myopia eyes had significantly smaller discs, a lower tilt ratio (0.73 ±0.09) and more disc tilt (56.5 percent) than did non-high-myopia eyes (0.80 ±0.09, 33.3 percent).
• In POAG, eyes with lower wedge-shaped RNFL defects had a significantly smaller torsion angle (-5.44 ±19.62 degrees, inferior disc torsion) than did eyes with upper defects (9.70 ±23.62 degrees, superior disc torsion; p=0.014).
• In NTG, a significantly decreased tilt ratio (0.74 ±0.93; p=0.001) and more disc tilt (55.9 percent, p=0.005) were found in eyes with lower wedge-shaped RNFL defects than in eyes with upper defects (0.81 ±0.09; 21.7 percent).
• The torsion degree in POAG and tilt ratio in NTG were the only factors associated with the location of wedge-shaped RNFL defects.
Researchers concluded that, in NTG, smaller and tilted discs were characteristic of high myopia. They added that disc tilt was associated with lower wedge-shaped RNFL defects. Furthermore, they wrote, in POAG, the direction of disc torsion corresponded to the location of the wedge-shaped RNFL defects.
SOURCE: Lan Yu-Wen, Chang S-Y, Sun F-J, et al. Different disc characteristics associated with high myopia and the location of glaucomatous damage in primary open-angle glaucoma and normal-tension glaucoma. J Glaucoma 2019; Feb 15. [Epub ahead of print].
The Sleep/Glaucoma Connection
Researchers from the Wilmer Eye Institute at Johns Hopkins University say that a patient’s sleep characteristics may be associated with glaucoma.
In this cross-sectional study, the researchers included 6,784 glaucoma patients from the 2005 to 2008 National Health and Nutrition Examination Survey who were age 40 and above and who had completed a detailed sleep questionnaire. Participants were asked such questions as, “How much sleep do you usually get at night on weekdays or work days?” and “How long does it usually take you to fall asleep?” The questionnaire was set up to look at the following predictors:
• sleep duration;
• sleep latency;
• sleep disorders;
• sleep disturbances;
• sleep medication use; and
• daytime dysfunction due to sleepiness.
The outcomes included disc-defined glaucoma (either right or left disc demonstrating glaucomatous features) and visual field defects (VFD) assessed by frequency-doubling perimetry.
The investigators found that the odds of disc-defined glaucoma were three times higher among subjects who slept for ≥10 hours per night compared with those who slept seven hours per night. The odds of disc-defined glaucoma were two times higher among subjects who fell asleep in ≤9 minutes and ≥30 minutes compared with 10 to 29 minutes. The odds of VFD were three times higher among subjects who slept for ≤3 hours per night, compared with seven hours per night. The odds of VFD were two times higher among subjects who had difficulty remembering things and three times higher among subjects who had difficulty working on a hobby due to daytime sleepiness compared with those without difficulty.
The researchers say there appear to be associations between glaucoma and abnormal sleep parameters, and that these abnormal sleep patterns may be a risk for, or consequence of, glaucoma.
SOURCE: Qiu M, Ramulu P, Boland M. Association Between Sleep Parameters and Glaucoma in the United States Population: National Health and Nutrition Examination Survey. J Glaucoma 2019;28:97-104.
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Photocoagulation vs. Ranibizumab for PDR
Scientists aimed to identify whether baseline characteristics of eyes with proliferative diabetic retinopathy were associated with better outcomes when treated with panretinal laser vs. ranibizumab in the DRCR.net Protocol S.
Participants had PDR, visual acuity of 20/320 or better, and no previous PRP. Eyes were randomized to PRP or intravitreous 0.5-mg ranibizumab. Here are some of the findings:
• Ranibizumab was superior to PRP for change in visual acuity and development of vision-impairing central-involved diabetic macular edema over two years (p<0.001).
• Among 25 characteristics, none in PRP participants were associated with superior outcomes relative to ranibizumab-assigned participants.
• The relative benefit of ranibizumab over PRP in terms of change in VA appeared greater in participants with higher mean arterial pressure (p=0.03); without previous focal/grid laser (p=0.03); with neovascularization of the disk and elsewhere on clinical exam (p=0.04); and with more advanced PDR on photographs (p=0.02).
• For development of vision-impairing central-involved DME, the relative benefit of ranibizumab over PRP seemed greater among non-white participants (p=0.01) and those with higher mean arterial pressure (p=0.01).
Scientists wrote that no identified characteristics were associated with superior outcomes using PRP vs. ranibizumab. They added that their exploratory analyses provides additional support for the premise that ranibizumab might be a reasonable alternative to PRP for PDR over a two-year period.
SOURCE: Bressler SB, Beaulieu WT, Glassman AR, et al. Photocoagulation versus ranibizumab for proliferative diabetic retinopathy. Retina 2019; Feb. 18 [Epub ahead of print].
Agreement & Predictors of Discordance Between Six VF Progression Algorithms
Researchers determined the agreement of six established visual field progression algorithms in a large dataset of VFs from multiple institutions and determined predictors of discordance among the algorithms, as part of a retrospective, longitudinal cohort.
VFs from five major eye-care institutions in the United States were evaluated. The analysis included a subset of eyes with at least five SITA-Standard 24-2 VFs that met reliability criteria. Of 831,240 fields, a subset of 90,713 VFs of 13,156 eyes of 8,499 individuals met the inclusion criteria.
Six commonly used VF progression algorithms (mean deviation slope, VF index slope, Advanced Glaucoma Intervention Study, Collaborative Initial Glaucoma Treatment Study, pointwise linear regression and permutation of pointwise linear regression) were applied to the cohort, and each eye was determined to be stable or progressing using each measure. Researchers tested agreement between individual algorithms using Cohen’s Kappa coefficient, and used bivariate and multivariable analyses to determine predictors of discordance (three algorithms progressing and three algorithms stable). Main outcome measures included agreement and discordance between algorithms. Here were some of the findings:
• Individual algorithms showed poor to moderate agreement with each other when compared directly (Kappa range: 0.12 to 0.52).
• 11.7 percent of eyes progressed based on at least four algorithms.
• Major predictors of discordance or lack of agreement between algorithms were more depressed initial MD (p<0.01) and older age at first available VF (p<0.01).
• A greater number of VFs (p<0.01), more years of follow-up (p<0.01) and the patient’s eye-care institution (p=0.03) were also associated with discordance.
Researchers found that existing algorithms had limited agreement, and varied with clinical parameters including institution. They added that these issues underscored challenges to the clinical use and application of progression algorithms and of applying “big data” results to individual practices.
SOURCE: Saeedi OJ, Elze T, D'Acunto L, et al. Agreement and predictors of discordance of six visual field progression algorithms. Ophthalmology 2019; Feb 4. [Epub ahead of print].
Clearside’s XIPERE Begins FDA Review
Clearside Biomedical received notification from the FDA that the agency will be reviewing the company’s New Drug Application for XIPERE (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection for the treatment of macular edema associated with uveitis. The Prescription Drug User Fee Act goal date (by which time the FDA has to render a decision) has been assigned for Oct. 19. The NDA filing is supported by data from the Phase III PEACHTREE clinical trial, which the company says demonstrated significant and clinically meaningful improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. Read more.
Ocular Therapeutix Announces First Patient Dosed in OTX-TKI (tyrosine kinase inhibitor implant) Phase I Trial
Ocular Therapeutix announced the dosing of the first patient at Australia’s Sydney Retina Clinic, in a Phase I trial of OTX-TKI (tyrosine kinase inhibitor implant) in individuals with wet age-related macular degeneration. The multicenter, open-label study is testing the safety, durability and tolerability of OTX-TKI, a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor delivered by intravitreal injection to individuals with wet AMD. The study will evaluate biological activity by measuring retinal thickness using optical coherence tomography and following visual acuity over time. Read more.
Ocugen Granted FDA Orphan Drug Designation for OCU400 Gene Therapy
Ocugen announced the FDA granted orphan drug designation for OCU400, the company’s novel gene therapy, for the treatment of NR2E3 mutation-associated retinal degenerative disease. OCU400 consists of adeno-associated virus serotype 5 capsid—containing the gene for human nuclear hormone receptor NR2E3. In a mouse model of the NR2E3 mutation, NR2E3’s delivery to retinal cells reversed disease progression. Based on these results, Ocugen plans to initiate a Phase I/IIa clinical study by 2020. Read more.
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