From the editors of Review of Ophthalmology:
Monday, February 17, 2020
FEBRUARY IS AGE-RELATED MACULAR DEGENERATION AWARENESS MONTH
In this issue: (click heading to view article)
OCTA Can Categorize Subgroups of CNV Secondary to AMD
Choroidal neovascularization characterizes wet age-related macular degeneration, showing a highly variable visual outcome. With this in mind, researchers performed a quantitative optical coherence tomography angiography assessment of CNV secondary to age-related macular degeneration at baseline in order to assess treatment outcomes.
Seventy-eight treatment-naïve wet-AMD patients (39 men, mean age 78 ±8 years) were recruited and underwent complete ophthalmologic evaluations and multimodal imaging. Several OCT and OCTA parameters were collected, including vessel tortuosity and vessel dispersion (VDisp), and measured for each segmented CNV. All patients underwent anti-vascular endothelial growth factor treatment as-needed. Scientists tested vessel tortuosity and VDisp values of CNVs at baseline to establish a cutoff able to distinguish clinically different patient subgroups. Here were some of the findings:
• Mean best-corrected visual acuity was 0.49 ±0.57 (20/62) at baseline, improving to 0.31 ±0.29 (20/41) at the one-year follow-up (p
<0.01), with a mean number of 6.4 ±1.9 injections.
• The cohort included the following CNV types: occult (45 eyes; 58 percent), classic (14 eyes; 18 percent) and mixed (19 eyes; 24 percent).
• After observing OCTA parameters, scientists found that classic, mixed and occult CNV revealed significantly different values of VDisp, with classic forms showing the highest values, and occult CNV showing the lowest (p
<0.01); mixed forms displayed intermediate VDisp values.
• ROC analysis revealed that a CNV vessel tortuosity cutoff of 8.40, calculated at baseline, enabled two patient subgroups differing significantly in visual outcomes after anti-VEGF treatment to be distinguished.
Scientists wrote that a baseline quantitative OCTA-based parameter could provide information regarding clinical and functional outcomes after anti-VEGF treatment in age-related macular degeneration-related CNV.
Source: Arrigo A, Romano F, Aragona E, et al. Optical coherence tomography angiography can categorize different subgroups of choroidal neovascularization secondary to age-related macular degeneration. Retina 2020; Feb 6. [Epub ahead of print.]
Temporal Wedge Defects in Glaucoma
Investigators used the Open Perimetry Interface to design a static automated perimetry test of the full visual field. They say that about half of the glaucoma cohort had defects in the far peripheral inferotemporal VF that correlated well with related damage to the superior nasal optic disc.
Investigators aimed to test the hypothesis that, in glaucoma patients with mild visual loss, perimetric nerve fiber bundle defects outside 30 degrees would correlate well with areas of OCT retinal nerve fiber layer thinning.
They tested 27 consecutive glaucoma subjects with mild vision loss (mean deviation better than -4 dB) with a SITA standard test, two size V custom Open Perimetry Interface tests (OPI 30-2 and OPI Peripheral) and OCT (Cirrus, Zeiss). Two observers assigned qualitative grades to each type of VF test based on their level of correlation with OCT RNFL and ganglion cell thickness. Here were some of the findings:
• Discrete temporal wedge defects were found on the OPI peripheral V test in 26 percent of cases, while more extensive inferior temporal loss (including in the inferior temporal wedge defect region) was present in 22 percent of other cases.
• OCT data correlated best with the OPI peripheral test for eight glaucoma subjects.
• The OPI central 30-2 test correlated best for nine glaucoma subjects; the remainder of subjects had equal central/peripheral correlations.
Investigators found that about half of the glaucoma cohort had defects in the far peripheral inferotemporal VF that correlated well with related damage to the superior nasal optic disc. They wrote that adding a threshold automated perimetry test of the far periphery improved structure/function correlations and added useful clinical information.
SOURCE: Wall M, Lee EJ, Wanzek RJ, et al. Temporal wedge defects in glaucoma: Structure/function correlation with threshold automated perimetry of the full visual field. J Glaucoma 2020; Jan 7. [Epub ahead of print].
Visual Function Decline Due to GA: Results from Chroma & Spectri
Researchers assessed visual function outcomes to 48 weeks in individuals with bilateral geographic atrophy secondary to age-related macular degeneration included in two, now defunct, interventional clinical trials for the failed dry-AMD drug candidate lampalizumab (Chroma and Spectri), including: relationship to baseline lesion size; outcomes by baseline lesion characteristic subgroups; and correlation of visual function outcomes with GA area. Though the drug didn’t reach its primary endpoint, the researchers say the trials can still yield some interesting information about GA.
Eligible participants were ages 50 years or more, with well-demarcated bilateral GA (lesion size, one to seven disc areas), without evidence of CNV or previous treatment for CNV in either eye, and best-corrected visual acuity letter score of 49 letters or more (≥1 GA lesion within 250 μm of foveal center if BCVA ≥79 letters). The patients (pooled n=1,881) were treated with different frequencies of dosing of the drug or sham.
Functional endpoints included change from baseline to week 48 in BCVA, low-luminance visual acuity, mesopic microperimetry (number of absolute scotomatous points, mean macular sensitivity), binocular/monocular maximum reading speed and two validated patient-reported outcome measures: Functional Reading Independence Index and the National Eye Institute Visual Function Questionnaire. Here were some of the results:
• Enlargement of GA area (measured on fundus autofluorescence)—approximately 2 mm2
/year on average across all treatment groups in each study—was accompanied by overall deterioration in all functional endpoints.
• Of visual function tests, only microperimetry outcomes were moderately correlated with GA lesion area when assessed cross-sectionally at baseline and week 48.
• All other functional parameters had no or weak correlation with GA lesion area.
showed acceptable rates of ECL, with safe and promising early clinical outcomes.
Researchers wrote that Chroma/Spectri provided a unique data set of functional endpoints in GA, relevant for future clinical trials. They added that individuals with bilateral GA experienced a consistent decline in visual function over 48 weeks, but measures of visual function weren’t strongly correlated with GA lesion area. Furthermore, they wrote, it wasn’t possible to predict visual function outcomes from GA lesion size.
SOURCE: Heier JS, Pieramici D, Chakravarthy U, et al. Visual function decline due to geographic atrophy: Results from the Chroma and Spectri phase 3 trials. Ophthalmology Retina 2020; Jan 31. [Epub ahead of print].
Dry Eye After Cataract Surgery in MGD Patients
Researchers evaluated dry-eye symptoms post-cataract surgery in MGD patients. The study included 115 patients (115 eyes) with age-related cataracts that underwent uncomplicated cataract surgeries. Individuals were divided into two groups according to the MGD diagnostic criteria: group A (MGD group) and group B (control group).
Schirmer I test (ST-I), tear breakup time and corneal fluorescein staining (CFS) were performed preoperatively and at three days, seven days, 14 days and 30 days postoperatively. Researchers also measured eyelid meibomian gland morphology, meibomian gland expression and meibum character scores before and after the cataract surgery. Here were some of the findings:
• Postoperatively, in group A, TBUT decreased and CFS scores increased significantly.
• ST-I increased in the early postoperative course but decreased later.
• The eyelid margin morphology scores and meibomian gland expression scores of group A significantly increased after cataract operations.
• Researchers found that MGD patients may have a greater chance of developing dry-eye disease after cataract surgery.
• The team determined that cataract surgery may aggravate the signs of MGD, and the severity of MGD may positively correlate with TBUT, CFS and corneal lesions after surgery.
Researchers wrote that the characteristics of post-cataract surgery dry eye in MGD patients were different from those in common cataract patients. They added that changes to the ocular surface in the early postoperative phase were caused by surgical factors, and damage to epithelial function in the later postoperative phase was mainly associated with the inflammation of the meibomian gland and eyelid.
SOURCE: Qiu JJ, Sun T, Fu SH, et al. A study of dry eye after cataract surgery in MGD patients. Int Ophthalmol. 2020 Jan 24. [Epub ahead of print].
Positive PANORAMA Results Announced
Regeneron Pharmaceuticals announced positive two-year results from the Phase III PANORAMA trial evaluating Eylea (aflibercept) injection 2 mg (0.05 mL) in individuals with moderately severe to severe non-proliferative diabetic retinopathy. The two-year, pre-specified, exploratory data demonstrated that untreated moderately severe and severe NPDR could lead to vision-threatening events, including vision-threatening complications (proliferative diabetic retinopathy or anterior segment neovascularization) and center-involved diabetic macular edema. Based on a Kaplan-Meier analysis, more than half (58 percent) of patients in the untreated sham arm developed a VTC or CI-DME within two years of entering the trial, while Eylea treatment was shown to reduce the likelihood of those vision-threatening events by at least 75 percent (nominal p<0.0001). Read more.
Kodiak Announces Positive Safety, Efficacy & Durability Data from KSI-301 Study
Kodiak Sciences announced promising safety, efficacy and durability data from the ongoing Phase Ib study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, in individuals with treatment-naïve wet age-related macular degeneration, diabetic macular edema or retinal vein occlusion. KSI-301, an investigational anti-VEGF therapy built on the company's antibody biopolymer conjugate platform, is designed to maintain effective drug levels in ocular tissues for longer than existing agents, the company says. Read more.
Lineage Provides Positive Update on OpRegen Phase I/IIa Study
Lineage Cell Therapeutics reported positive findings from its ongoing Phase I/IIa clinical study of OpRegen, the company’s retinal pigment epithelium transplant therapy for the treatment of dry age-related macular degeneration. All five patients in cohort 4, those with better baseline vision and which represent the company’s intended patient population, showed increases in best-corrected visual acuity. Notably, the first cohort-4 patient dosed with both the company’s new thaw-and-inject formulation and Orbit subretinal delivery system gained 25 readable letters (or five lines) at six months following administration of OpRegen RPE cells as assessed by the Early Treatment Diabetic Retinopathy Scale (ETDRS), the company says. Read more.
Calvin Roberts, MD, Named President, CEO of Lighthouse Guild
Calvin Roberts, MD, senior vice president and chief medical officer for eye care at Bausch Health Companies, and clinical professor of ophthalmology at Weill Cornell Medical College, was elected president and CEO of the Lighthouse Guild, effective April 1. As a practicing ophthalmologist from 1982 to 2008, Dr. Roberts performed more than 10,000 cataract surgeries as well as 5,000 refractive and other corneal surgeries. He co-founded a specialty pharmaceuticals company, led the development and commercialization of pharmaceuticals, and has served as a consultant to Allergan, Johnson & Johnson and Novartis. Read more.
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