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| Vol. 20, #40 • Monday, September 21, 2020 |
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SEPTEMBER IS HEALTHY AGING MONTH
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Effect of Aflibercept on DR Severity & Visual Function
Researchers evaluated the effect of intravitreal aflibercept on diabetic retinopathy severity and visual function in subjects with proliferative diabetic retinopathy without diabetic macular edema, as part of a multicenter clinical trial, the RECOVERY study.
Forty eyes of 40 subjects with PDR and no DME were enrolled in this study. Subjects were randomized into monthly and quarterly 2 mg aflibercept injection cohorts and treated over a period of 12 months. All subjects underwent ultra-widefield fundus imaging, including pseudocolor and fluorescein angiography using an Optos 200Tx device.
Main outcome measures included severity of retinopathy at baseline, month six, and month 12, evaluated by certified reading center graders using the diabetic retinopathy severity scale. DRSS scores were correlated with the 25-item and 39-item Visual Function Questionnaire scores at baseline and month 12.
Mean age of the subjects was 48.2 years (range: 25 to 75); mean duration of diabetes mellitus was 16.1 years (range: two to 36 years); and median HbA1c was 8.8 percent (IQR: 7.4 to 10). Here were some of the findings:
• Both monthly and quarterly groups demonstrated a statistically significant regression in DRSS from baseline to month 12 (p<0.001).
• The monthly group demonstrated a statistically significant greater regression of DRSS score at the month six visit compared to the quarterly group (p=0.019). However, the difference between the groups became statistically insignificant at the month 12 visit (p=0.309).
• At month 12, no difference was found in mean VFQ-25 and VFQ-39 composite scores between the monthly group (p=0.947) and quarterly group (p=0.921).
• At month 12, the improvement in mean composite scores below were significantly correlated with improvement in DRSS:
o for VFQ-25: r=0.384, p=0.039; and
o for VFQ-39: r=0.361, p=0.046.
Researchers wrote that, in this study of eyes with PDR without DME, monthly and quarterly aflibercept injection groups showed significant improvement in diabetic retinopathy severity at month 12 compared to baseline. They added that the improvement in DRSS was associated with an improvement in VFQ composite score.
SOURCE: Alagorie AR, Velaga S, Nittala MG, et al. Effect of aflibercept on diabetic retinopathy severity and visual function in the RECOVERY study for proliferative diabetic retinopathy. Ophthalmol Retina 2020; Aug 31. [Epub ahead of print].
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Complimentary CME Education Videos
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Association Between Corneal Hysteresis & Trabecular MIGS Outcomes
Investigators assessed whether an association existed between pretreatment corneal hysteresis (CH), and the magnitude of intraocular pressure and medication burden reduction following minimally-invasive glaucoma surgery. One of the authors is a consultant for Reichert, maker of the corneal hysteresis measurement device.
They initiated a retrospective chart review of 84 eyes from 57 individuals with CH measurements who underwent trabecular meshwork MIGS in a glaucoma practice in New York City with follow-up visits at three to six and nine to 12 months. MIGS included canaloplasty, goniotomy, microbypass stents or a combination of the procedures. Here were some of the findings:
• The lowest and middle CH tertiles experienced significantly reduced mean IOP at three-to-six-month follow-up (p=0.007, <0.001), while the highest tertile didn’t (p=0.06).
• At nine-to-12-month follow-up, a significant mean IOP reduction only persisted in the middle tertile (p=0.001).
• For medication burden reduction, only the highest CH tertile experienced significant mean reductions at both three-to-six-month (p=0.015) and nine-to-12-month (p=0.028) follow-ups.
• Seven individuals in the lowest CH tertile failed MIGS and required an additional surgical or laser procedure within 24 months of MIGS, while only three individuals failed in the other tertiles (likelihood ratio <0.05).
• Multivariate analysis excluding MIGS failures demonstrated an inverse association between CH and the magnitude of postoperative IOP reduction at both three-to-six-month (p=0.002), and nine-to-12-month (p=0.026) follow-ups when controlling for baseline IOP and medication changes.
Investigators found an inverse association between pretreatment CH and the magnitude of IOP reduction following surgery. They also uncovered evidence of an increased need for repeat surgery or other intervention in individuals with lower CH who underwent MIGS.
Source: Tracer N, Ayoub S, Radcliffe NM. The association between corneal hysteresis and surgical outcomes from trabecular meshwork microinvasive glaucoma surgery. Graefes Arch Clin Exp Ophthalmol 2020; Sep 12. [Epub online ahead of print.]
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Complimentary CME Education Videos
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Automated Digital Analysis of Astigmatism After Big-bubble DALK
Scientists looked at the correlation between postoperative corneal astigmatism and values of intraoperative keratoscopy analyzed with a newly developed automated technique in individuals undergoing big-bubble deep anterior lamellar keratoplasty.
Photographs of keratoscope rings taken at the end of BB-DALK were analyzed using ImageJ for the calculation of “roundness” (R). A value of 1 indicated a perfect circle. Pearson’s correlation was used to evaluate the relationship between R and PCA that measured: one week (V1); three months (V2); and 18 months (V3), postoperatively. The area under the receiver operating characteristic curve was used to evaluate the accuracy of R for identifying patients with PCA <3 D. The point on the ROC curve nearest to the coordinate (0,100) was used as a cutoff to determine sensitivity and specificity.
Data from 121 patients were included. Here were some of the findings:
• The mean value of R was 0.93 ±0.04 (range: 0.76 to 0.99).
• R showed a significant correlation with PA at V3 (R=-0.42, p<0.01).
• The ROC curve had an AUC of 0.69 (CI, 0.59 to 0.79).
• A cutoff value of R=0.93 had a sensitivity of 70.3 percent and specificity of 61 percent for identifying individuals with PCA <3D at V3.
Scientists wrote that the new digital analysis of keratoscope rings helped identify, with reasonably good diagnostic accuracy, individuals with low values of post-DALK astigmatism correctable with spectacles.
SOURCE: Giannaccare G, Lucisano A, Pellegrini M, et al. Automated digital analysis of intraoperative keratoscopy and its correlation with postoperative astigmatism after big-bubble deep anterior lamellar keratoplasty. Graefes Arch Clin Exp Ophthalmol 2020; Sep 4. [Epub ahead of print].
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Using Machine Learning to Predict AMD Progression
Researchers wrote that existing prediction models for advanced age-related macular degeneration are based on a restrictive set of risk factors. They aimed to develop a comprehensive prediction model, applying a machine learning algorithm allowing selection of the most predictive risk factors automatically.
Two population-based cohort studies were utilized. The Rotterdam Study I (RS-I, training set) included 3,838 participants ages 55 years or older, with a median follow-up period of 10.8 years and with 108 incident cases of advanced AMD. The ALIENOR study (test set) included 362 participants ages 73 years or older, with a median follow-up period of 6.5 years and with 33 incident cases of advanced AMD.
The prediction model used the bootstrap lasso for survival analysis to select the best predictors of incident advanced AMD in the training set. Predictive performance of the model was assessed using the area under the receiver operating characteristic curve. Main outcome measures included incident advanced AMD (atrophic and/or neovascular), based on standardized interpretation of retinal photographs.
The prediction model retained:
• age;
• a combination of phenotypic predictors (based on the presence of intermediate drusen; hyper-pigmentation in one or both eyes; and Age-Related Eye Disease Study simplified score);
• a summary genetic risk score based on 49 single nucleotide polymorphisms;
• smoking;
• diet quality;
• education; and
• pulse pressure.
Here were some of the findings:
• The cross-validated AUC estimation in RS-I was:
o 0.92 (0.88 to 0.97) at five years;
o 0.92 (0.90 to 0.95) at 10 years; and
o 0.91 (0.88 to 0.94) at 15 years.
• In ALIENOR, the AUC reached 0.92 at five years (0.87 to 0.98).
• In terms of calibration, the model tended to underestimate the cumulative incidence of advanced AMD for the high-risk groups, especially in ALIENOR.
Researchers reported that the prediction model reached high discrimination abilities, paving the way toward making precision medicine for AMD patients a reality in the not-too-distant future.
SOURCE: Ajana S, Cougnard-Grégoire A, Colijn JM, et al. Predicting progression to advanced age-related macular degeneration from clinical, genetic and lifestyle factors using machine learning. Ophthalmology 2020;Sep 2. [Epub ahead of print].
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Industry News
Novartis Reports Topline Results From Phase III Trial of Beovu vs. Aflibercept
Novartis reported the Phase III KITE study assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema met its primary and key secondary endpoints, demonstrating non-inferiority vs. aflibercept 2 mg in mean change in best-corrected visual acuity at year one (week 52). In a secondary endpoint, Beovu demonstrated superior improvement vs. aflibercept in change of central subfield thickness over week 40 through week 52. Since Beovu has been dealing with issues regarding inflammation in some patients, physicians will be interested to hear that the company says the rate of intraocular inflammation in the study was equivalent between Beovu and aflibercept. Read more.
BVI Introduces Patient Packs
BVI released a line of Patient Packs that it says will help U.S. ophthalmologists bring patients back to the office and surgical suite “with confidence.” BVI Patient Packs provide a ready-to-use package that includes a face mask, bouffant cap, shoe covers and an optional isolation gown along with patient instructions. Read more.
Gemini Enrolls First Patient in Phase IIa Study of GEM103
Gemini Therapeutics initiated enrollment in its Phase IIa ReGAtta study, evaluating GEM103, a recombinant, human complement factor H for the treatment of individuals with geographic atrophy secondary to dry age-related macular degeneration. Read more.
LumiThera and Diopsys Collaborate and Enroll First Subject in ELECTROLIGHT Study, LumiThera Receives $1.5 Million NEI Grant
LumiThera is collaborating with Diopsys, a provider of visual electrophysiology solutions, to help eye-care professionals accurately and objectively measure retinal and visual pathway function. The collaboration supports a prospective pilot clinical trial in U.S. subjects that will evaluate the ability of the “photobiomodulation” treatment using the Valeda Light Delivery System to improve electroretinogram outcomes in subjects with dry AMD. Read more.
In addition, LumiThera received a small business innovative research Phase II grant from the National Institutes of Health and the National Eye Institute to support a prospective, randomized, multicenter human clinical trial of its light-delivery system in U.S. subjects diagnosed with diabetic retinopathy and diabetic macular edema. Read more.
Keeler USA & Olleyes Partner
Keeler, a provider of ophthalmic diagnostic, digital, surgical and clinical products, announced its U.S. partnership with Olleyes, a medical device company developing office and home-based diagnostic products to improve productivity in eye care with VisuALL VRP (Virtual Reality Perimetry). The VisuALL, designed for standardized and mobile assessment of the visual fields and visual acuity, automatically analyzes the retinal sensitivity in individuals with glaucoma and other visual disorders. It enables the examination of multiple patients at a time and automatically analyzes the retinal sensitivity in patients with glaucoma and other visual disorders. The product’s mobility enables providers to adhere to current health and safety protocols. For information, visit keelerusa.com or call 1-800-523-5620.
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