Review of Ophthalmology Online



Vol. 22, #15  •   Monday, April 12, 2021


In this Issue:


OCTA Artifacts in Glaucoma

Researchers determined the prevalence of different types of artifacts seen in optical coherence tomography angiography images of healthy and glaucoma eyes, and evaluated the characteristics associated with the increased likelihood of obtaining poor quality images, as part of a retrospective study.

A total of 649 eyes of 368 healthy individuals, glaucoma suspects and glaucoma patients were included.

Angiovue high-density (HD) and non-HD optic nerve head and macula OCTA images of participants were evaluated by four expert reviewers for the presence of different artifacts, including: eye movement; defocus; shadow; decentration; segmentation error; blink; and Z offset in the superficial vascular layer. Each OCTA scan was designated to have good or poor quality based on the presence of artifacts. Researchers evaluated the association of demographic and ocular characteristics with the likelihood of obtaining poor-quality OCTA images, using a generalized linear mixed model.

Main outcome measures included the prevalence of OCTA artifacts and factors associated with increased likelihood of capturing poor-quality OCTA images.

A total of 5,263 OCTA images were evaluated. Here were some of the findings:
• Overall, 33.9 percent of the OCTA images had poor quality.
• The majority of images with acceptable quality scores (QS ≥4) had no artifacts (76.6 percent).
• Other images had one (13.6 percent), or two or more artifacts (9.8 percent).
• Older age (p<0.001), male gender (p=0.045), worse visual field mean deviation (p<0.001), absence of eye tracking (p<0.001) and macular scan area (p<0.001) were associated with a higher likelihood of obtaining poor quality images.
• In images with acceptable quality scores, commercially available quality measures including quality scores and signal strength index had area under the ROC curves of 0.65 (CI, 0.62, 0.69) and 0.70 (CI, 0.68 to 0.73), respectively, to detect good-quality images.

Researchers concluded that OCTA artifacts were frequently associated with poor-quality images, and their prevalence was affected by ocular and patient characteristics. They suggested that clinicians shouldn’t rely solely on quantitative assessments provided automatically by OCTA instruments. Rather, researchers advised, clinicians should conduct a systematic scan review to ensure appropriate interpretation of OCTA images. Furthermore, they added, given the high prevalence of poor-quality OCTA images, images should be reacquired whenever an apparent and correctable artifact is present on a captured image.

SOURCE: Kamalipour A, Moghimi S, Hou H, et al. Optical coherence tomography angiography artifacts in glaucoma. Ophthalmol 2021; April 2 [Epub ahead of print].




Efficacy and Safety of Intravitreal Aflibercept Using a T&E Regimen for nAMD: The Aries Study

Treating neovascular age-related macular degeneration with intravitreal aflibercept (IVT-AFL) using a treat-and-extend (T&E) regimen can reduce treatment burden. ARIES investigators assessed whether IVT-AFL early-start T&E was noninferior (NI) to late-start T&E.

The randomized, open-label, Phase IIIb/4 study included treatment-naïve patients ages ≥50 years with best-corrected visual acuity of 73 to 25 Early Treatment Diabetic Retinopathy Study letters and active choroidal neovascularization secondary to AMD.

Patients received 2 mg IVT-AFL at week 0, W4, W8 and W16. At W16, patients were randomized 1:1 to early-start (two-week interval adjustments) or late-start T&E (eight-week intervals until W48, then two-week interval adjustments). The primary endpoint was BCVA change from randomization to W104.

A total of 271 patients were randomized. Mean BCVA at baseline was 60.2 ±12.1 letters (early-start T&E) and 61.3 ±10.8 letters (late-start T&E). Here were some of the findings:
• Mean BCVA change (W16 to 104) was:
   o -2.1 ±11.4 vs. -0.4 ±8.4 letters (early vs. late-start T&E; least-squares mean difference: -2; CI, -4.75 to 0.71; p=0.0162 for NI);
   o +4.3 ±13.4 vs. +7.9 ±11.9 letters (W0 to 104).
• Mean number of injections was 12 ±2.3 vs. 13 ±1.8.
• From baseline to W104, 93.4 percent and 96.2 percent maintained BCVA; mean central retinal thickness change was -161.6 ±135.6 µm and -158.6 ±125.1 µm.
• Last injection interval (W104) was ≥12W for 47.2 percent and 51.9 percent of patients.

Investigators determined that outcomes were similar between nAMD patients treated with an IVT-AFL early- or late-start T&E regimen following initial dosing, with one injection difference over two years.

SOURCE: Mitchell P, Holz FG, Hykin P, et al. Efficacy and safety of intravitreal aflibercept using a treat-and-extend regimen for neovascular age-related macular degeneration: The Aries study. Retina 2021; Mar 22. [Epub ahead of print].




Predictors of Progression in Untreated Keratoconus

Scientists aimed to identify risk factors for progression in untreated keratoconus patients from 34 centers across Australia, New Zealand, Spain and Italy.

Patients were divided into “progressors” and “stable” patients for each clinical parameter: visual acuity; steepest keratometry (maximum keratometry [Max-K]); and thinnest corneal thickness (TCT). Primary outcomes were the portion of eyes with sustained progression in VA, Max-K or TCT within three years. Secondary outcomes included predictors of progression.

A total of 3,994 untreated eyes from 2,283 patients were included. Here were some of the findings:
• The portion of eyes with VA, Max-K and TCT progression at one year were 3.2 percent, 6.6 percent and 3.1 percent, respectively.
• Factors associated with VA loss were higher baseline VA (HR: 1.15 per logMAR line increase in VA; p<0.001) and steeper baseline Max-K (HR 1.07 per 1D increase; p<0.001).
• Younger baseline age was associated with Max-K steepening (HR: 0.96 per year older; p=0.001).
• Thicker baseline TCT (HR: 1.08 per 10-µm increase in TCT; p<0.001); steeper baseline Max-K (HR: 1.03 per 1-D increase; p=0.02); and younger baseline age (HR: 0.98 per year younger; p=0.01) were associated with TCT thinning.

Scientists found that steeper Max-K and younger age were the most clinically useful baseline predictors of progression, since they were associated with the worsening of two clinical parameters. They added that every 1 D steeper Max-K was associated with a 7 percent and 3 percent greater risk of worsening VA and thinning TCT, respectively. In addition, for each one year of younger age, there was an associated 4 percent and 2 percent greater risk of steepening Max-K and thinning TCT, respectively.

SOURCE: Ferdi A, Nguyen V, Kandel H, et al. Predictors of progression in untreated keratoconus: A Save Sight Keratoconus Registry study. Br J Ophthalmol 2021; Mar 30. [Epub ahead of print].


Hypertension and Wet AMD

Researchers aimed to investigate the association between hypertension, wet age-related macular degeneration and the treatment strategy of wet AMD patients affected by hypertension.

Data of wet AMD patients at Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2002 and June 2019, were extracted from the electronic health-care information system. Wet AMD patients were divided into subgroups by hypertension status, age, sex, the need for vitrectomy surgery and the number of anti-VEGF drug intravitreal injections (1 to 3 vs. >3).

A total of 3,096 wet AMD patients (41.7 percent female, 58.3 percent male) with an age range of 50 to 96 years (68.7 ±9.42 years) were included. Here were some of the findings:
• Wet AMD was significantly associated with hypertension (p<0.001).
• After adjustment for sex and age, a Cox regression model showed a significant association between hypertension in wet AMD patients and the number of injections (RR=1.31, CI, 1.13 to 1.50; p<0.001).
• No significant association was found between hypertension and the need for vitrectomy (p=0.82).

Researchers wrote that wet AMD was associated with hypertension, and wet AMD patients with hypertension were more likely to receive anti-VEGF drug intravitreal injections than those without hypertension. They suggested that these results may prompt prospective research on the prevention of wet AMD and may aid in the management of wet AMD patients.

SOURCE: Wang T, Xia J, Yuan M, et al. Hypertension affects the treatment of wet age-related macular degeneration. Acta Ophthalmol 2021; Mar 31. [Epub ahead of print.]




Industry News

Eylea Injections’ Effect in NPDR

JAMA Ophthalmology recently published the initial results from the National Institutes of Health-sponsored Protocol W trial assessing Eylea (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy, without center-involved diabetic macular edema, compared to standard treatment. At two years, the primary outcome of the trial showed a 68 percent reduced risk of developing vision-threatening complications in patients who received the Eylea every-16-weeks dosing regimen. However, at two years, the injection’s effect on vision was similar to standard treatment, which usually begins at the onset of late disease, the NIH says. Read more.


Ocuphire Initiates ZETA-1 Phase II Trial Investigating APX3330 in DR

Ocuphire Pharma screened the first patient in ZETA-1, a Phase II trial to evaluate APX3330 in non-proliferative diabetic retinopathy and mild proliferative diabetic retinopathy. Effects on diabetic macular edema will be explored as a secondary outcome. APX3330 is a small molecule oral drug that inhibits the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1). The company says APX3330 blocks the downstream pathways regulated by Ref-1, including those involving angiogenesis and inflammation (NF-kB), to decrease abnormal activation of angiogenesis and inflammatory pathways implicated across several retinal diseases. Read more.



FDA Approves B+L ClearVisc Dispersive Ophthalmic Viscosurgical Device

Bausch + Lomb announced the FDA approved ClearVisc dispersive ophthalmic viscosurgical device for use in ophthalmic surgery. ClearVisc contains sorbitol, a chemical agent that the company says has been shown in a laboratory study to deliver protection from free radicals. The company adds that free radicals can contribute to corneal damage. In a multicenter, randomized, clinical study of 372 subjects, ClearVisc met its primary safety and efficacy endpoints and was demonstrated to be non-inferior to Viscoat, B+L says. Read more.



J&J Vision Announces Global Collaboration with Menicon to Address Myopia in Children

Johnson & Johnson Vision announced a global strategic collaboration with Menicon, a manufacturer of innovative contact lenses. The collaboration is part of a broader commitment from Johnson & Johnson Vision to bring forward a novel portfolio of products and services to manage the progression of myopia in children. As part of the collaboration, Menicon will develop and manufacture therapeutic contact lenses to help manage the progression of myopia in children. Johnson & Johnson Vision will focus on expanding availability of these lenses around the world. Learn more.

ForeseeHome AMD Home Monitoring Study Confirms Earlier Results

A retrospective study funded by Notal Vision on the use of its ForeseeHome AMD monitoring program found results that were similar to those from the 2014 randomized, controlled AREDS2-HOME study, the company says. Notal says the use of ForeseeHome helped detect wet AMD earlier and with better visual acuity, “a factor previously shown to improve long-term visual outcomes of anti-VEGF treatment.” Read more.



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