Review of Ophthalmology Online



Vol. 22, #1   •   Monday, January 4, 2021


In this Issue:


Non-resolving Subretinal Fluid in nAMD

Researchers described the clinical characteristics and visual outcomes of neovascular age-related macular degeneration (NV-AMD) patients with irregular pigment epithelium detachment (PED) and non-resolving subretinal fluid (SRF) despite continuous monthly injections of anti-vascular endothelial growth factor.

This was a retrospective case series including NV-AMD patients treated in a tertiary academic practice. Inclusion criteria were NV-AMD diagnosis, irregular PED and non-resolving SRF treated with continuous monthly anti-VEGF intravitreal injections. Data collection included best-corrected visual acuity, central macular thickness (CMT), subfoveal choroidal thickness, and type and location of PED as seen on optical coherence tomography.

A total of 738 patients with NV-AMD underwent anti-VEGF injections during the follow-up period, and 20 eyes of 19 patients (14 females and five males) met the inclusion criteria. Average age was 81.7 ±6.6 years, mean follow-up time was 32.1 ±23.5 months and mean number of injections was 31.3 ±24.2. Mean VA was 0.26 ±0.21 logMAR (Snellen 20/36) at baseline vs. 0.20 ±0.23 logMAR (Snellen 20/32) at the end of the follow-up (p=0.28). All eyes presented with subfoveal, type 1 macular neovascularization (MNV). Average subfoveal choroidal thickness changed from 189.70 ±68.46 μm at baseline to 169.00 ±63.06 μm (p<0.001) at last follow-up.

Researchers concluded that patients with type 1 NV-AMD, irregular PED and non-resolving SRF who are under continuous treatment of monthly anti-VEGF injections may maintain good visual acuity after a long period of time.

SOURCE: Hosseini H, Rabina G, Pettenkofer M, et al. Clinical characteristics and visual outcomes of non-resolving subretinal fluid in neovascular AMD despite continuous monthly anti-VEGF injections: A long-term follow-up. Graefes Arch Clin Exp Ophthalmol 2020; Nov 27. [Epub ahead of print].


Stromal Peeling for DALK

Investigators evaluated the clinical outcomes of deep anterior lamellar keratoplasty via stromal peeling in eyes that previously underwent penetrating keratoplasty for keratoconus.

Standardized stromal exchange included:
• 9 mm trephination of the recipient bed outside the old PK wound;
• creation of a partial anterior corneal flap through lamellar dissection across the PK wound;
• opening the stromal component of the old PK wound using blunt-tipped Vannas scissors until a plane of separation was reached;
• severing the attachment of the PK surgical scar from the recipient host;
• peeling the stroma of the PK graft from the underlying tissue and suturing the donor anterior corneal lamella, prepared by microkeratome dissection (450 µm depth, 9 mm diameter).

Main outcome measures were success rate, best spectacle-corrected visual acuity and endothelial cell loss (ECL).

Here were some of the findings:
• Of 21 post-PK eyes, stromal exchange succeeded in all but three cases, which were converted to a two-piece mushroom PK.
• After complete suture removal, mean BSCVA significantly improved from 0.95 ±0.39 logMAR preoperatively to 0.23 ±0.17 logMAR (p<0.001).
• Mean ECL was 5.4 ±23.2 percent.
• Double anterior chamber formation occurred in eight cases (44 percent), which all resolved after a single re-bubbling.

Investigators wrote that, in post-PK eyes, stromal exchange was performed by means of simple peeling without deep anterior lamellar dissection of the previous PK graft. They added that large-diameter (9 mm) repeat keratoplasty through stromal peeling yielded excellent visual outcomes and minimal ECL. Further, investigators wrote, double anterior chamber formation threatened to complicate the postoperative course, but prompt intervention enabled successful management.

SOURCE: Bovone C, Nahum Y, Scorcia V, et al. Stromal peeling for deep anterior lamellar keratoplasty in post-penetrating keratoplasty eyes. Br J Ophthalmol 2020; Nov 26. [Epub ahead of print].


Progression from Intermediate to Exudative AMD

Scientists evaluated the 10-year incidence of progression from intermediate to exudative age-related macular degeneration, and identified genetic and environmental factors influencing progression in a Korean population, as part of a retrospective, observational cohort study.

In 632 eyes of 418 patients (age, ≥50 years) with intermediate AMD, scientists assessed the incidence of exudative AMD from color fundus photographs and optical coherence tomography images obtained at baseline and annual visits. They acquired data regarding lifestyle variables and dietary habits with comprehensive questionnaires. And they analyzed genotyping data concerning three single nucleotide polymorphisms (SNPs): rs800292 and rs1061170 in C FH; and rs10490924 in ARMS2. Scientists estimated cumulative incidence of exudative changes using Kaplan-Meier analysis, and evaluated associated influential factors using univariate and multivariate Cox regression models.

The mean follow-up period was 3.99 ±2.85 years. Here were some of the findings:
• The cumulative incidence of progression to exudative AMD was: 5.6 percent at two years; 14.8 percent at five years; and 28.4 percent at 10 years.
• Multivariate Cox analysis revealed: age (harzard ratio [HR], 1.041; p=0.0393); family history of AMD (HR, 3.175; p=0.0184); and pre-existing exudative AMD in the fellow eye (HR, 3.186; p=5.31 x 10 -5) were positively associated with exudative changes.
• Regular green tea intake (HR, 0.632; p=0.0475) was associated with decrease in exudative changes.
• ARMS2 rs10490924 (HR, 1.482; p=0.0185) showed a significant association with AMD progression.

Scientists wrote that the annual progression rate from intermediate to exudative AMD in the Korean population was approximately 2.8 percent, which was comparable with that in Caucasians. They added that green tea intake may be a modifiable protective factor against exudative changes.

SOURCE: Joo K, Mun YS, Sang Park SJ, et al. Ten-year progression from intermediate to exudative age-related macular degeneration and risk factors–bundang AMD cohort study report 1. Am J Ophthalmol 2020; Dec 3. [Epub ahead of print].


OCTA and VF Progression in PACG

Researchers looked at the association between optical coherence tomography angiography features and prior visual field progression in primary angle-closure glaucoma.

In a cross-sectional study, 46 eyes of 31 PACG patients with five reliable VF exams performed over ≥3 years of follow-up underwent OCTA imaging.

Using linear mixed models, researchers evaluated: effect of clinical exam findings (age, gender, number of anti-glaucoma medications; mean and SD of intraocular pressure during follow-up); OCT (average retinal nerve fiber layer and ganglion cell complex thickness) and OCTA (whole en face vessel density of disc and macular scan, deep-layer microvascular dropout [MvD]) parameters on the rate of mean deviation (MD) change.

Here were some of the findings:
• The average (±standard deviation) MD of the baseline VF was -7.4 ±7.3 dB, and rate of MD change was -0.32 ±0.29 dB/year.
• Whole en face vessel density was: disc, 39.5 ±8.1 percent; and macular scans, 38.7 ±4.4 percent.
• MvD was noted in 33.3 percent of the eyes.
• Multivariate mixed models showed that lower whole en face disc (coefficient: 0.02, p=0.03) and macular vessel densities (coefficient: 0.04, p=0.02) were significantly associated with faster rate of MD decline.
• Other factors significantly associated with faster progression in multivariate models were older age (coefficient: -0.02, p<0.05), the presence of systemic hypertension (coefficient: -0.37, p=0.01) and diabetes (coefficient: -0.28, p=0.05).

Researchers concluded that lower superficial vessel density measured using OCTA was significantly associated with faster VF progression in PACG. They added that OCTA parameters can serve as biomarkers suggestive of past VF progression in PACG eyes.

SOURCE: Rao HL, Srinivasan T, Pradhan ZS, et al. Optical coherence tomography angiography and visual field progression in primary angle closure glaucoma. J Glaucoma 2020 Dec 2. [Epub ahead of print].




Complimentary CME Education Videos


Industry News

Novartis Reports Positive Topline Results From Second Phase III Trial of Beovu

Novartis announced positive findings from the Phase III KESTREL study, which assessed the efficacy and safety of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema. Following KITE, KESTREL is the second Phase III study of Beovu in DME. The recent trial met its primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline of Beovu 6 mg to aflibercept 2 mg at year one. And it also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521. (Beovu 6 mg is the marketed dose for wet AMD.) Read more.



Regenxbio Announces Dosing of First Patient in Phase II ALTITUDE Trial

Regenxbio announced the first patient was dosed in ALTITUDE, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of diabetic retinopathy. The trial is expected to enroll approximately 40 patients with DR across two cohorts. Patients will be randomized to receive RGX-314 vs. observational controls at a 3:1 ratio, and two dose levels of RGX-314 will be evaluated. The primary endpoint is the proportion of patients that improve in DR severity based on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at 48 weeks. Read more.






FDA Accepts Rezolute’s IND Application for RZ402

Rezolute announced the FDA accepted its Investigational New Drug application for RZ402, an orally available plasma kallikrein inhibitor that is in development for the treatment of diabetic macular edema. The company expects to initiate a Phase I, first-in-human clinical study with RZ402 in the first quarter of 2021. The company says RZ402, by inhibiting the formation of kallikrein, blocks the pro-inflammatory, pro-coagulant and fluid-leakage cascade triggered by up-activation of the contact activation system in the setting of DME and other vascular-mediated diseases. Read more.



Bruder Introduces Pre-Surgical Patient Prep Kit

Responding to demand from eye-care professionals, Bruder collaborated with ophthalmic surgeons and comanaging optometrists to develop the Bruder Sx Pre-Surgical Patient Prep Kit. The hygiene products needed by presurgical patients are available in a single, self-contained kit that doctors can provide directly in their practices or via the company’s new online patient portal, specifically designed for presurgical patients. The kit includes the company’s hygienic eyelid cleansing wipes, its hygienic eyelid solution, the Bruder Sx Pre-Surgical Compress and the Bruder Sx Case. Learn more.

Optos Introduces UWF Imaging Advancements

Optos’ line of ultra-widefield imaging devices are offering several advancements:
• The Daytona model has improved optics for visualization across the optomap image and automatic laterality detection to improve image capture time. It also features an updated design and user interface.
• The Silverstone model, which offers optomap-guided swept source optical coherence tomography, includes a Repeat Scan tool for monitoring changes over time, and an Explorer mode to display OCT scan type and location. In addition, auto contrast is available for angiography capture. Learn more about the company.

Verana Health & Partners Announce the Start of MIGS Study

Verana Health announced the start of the Patient-Reported Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study with the first participant enrolled. The project, which includes the FDA, UCSF-Center of Excellence in Regulatory Science and Innovation and Stanford University, American Academy of Ophthalmology and American Glaucoma Society as partners, will develop a patient-reported outcome instrument known as the Glaucoma Outcomes Survey that can be used for future FDA submissions for MIGS devices, and may help answer important health-related quality of life questions for patients affected by glaucoma. Read more.

GRF Video Encourages Patients to Visit Eye Doctors During COVID-19

The Glaucoma Research Foundation released a six-minute video designed to encourage glaucoma patients to visit their eye care provider for the care they need during the COVID-19 pandemic. The free video, made with the support of Aerie Pharmaceuticals, is entitled “See You Soon!” and is available for eye care professionals to download and share. Access the resource.

Keeler Opens Portal

Keeler, which specializes in ophthalmic diagnostic, digital, surgical, and clinical products recently launched its Global Portal at Keeler says the new site will allow physicians, technology groups, the ophthalmic industry, and future partners to engage with the company on original equipment manufacturer services, strategic partnerships and product ideas to bring to market. Read More.









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