Review of Ophthalmology Online



Vol. 22, #23  •   Monday, June 7, 2021


In this Issue:


Relationship Between Macular Vessel Density & Total Retinal Blood Flow in POAG

Researchers assessed the relationship between macular vessel density metrics and total retinal blood flow in primary open-angle glaucoma.

A total of 24 POAG and 19 healthy control subjects participated in the study. Subjects underwent optical coherence tomography and angiography for measurements of inner retinal thickness (IRT), vessel density (VD), and spacing between large and small vessels (SLV, SSV). Doppler OCT imaging was performed for total retinal blood flow (TRBF) measurements. In POAG subjects, automated perimetry was performed and visual field loss expressed as mean deviation was measured.

Here were some of the findings:
• Compared to the control group, the POAG group had decreased VD, TRBF and IRT, and increased SLV (p<0.0001).
• Decreased VD (Pearson correlation, r=0.51; p<0.0001; N=43) and increased SLV (Spearman correlation, rs=-0.47; p=0.001) were correlated with decreased TRBF.
• Decreased VD and SSV (r≥0.39; p≤0.001; n=43) and increased SLV (rs=-0.71; p<0.0001) were associated with decreased IRT.
• Decreased VF MD was correlated with decreased VD, SSV and IRT (r≥0.53; p≤0.001; N=24), and with increased SLV (rs=-0.84; p<0.0001).

Researchers wrote that their findings of an association between macular vessel density and total retinal blood flow supports the role of vascular factors in the pathophysiology of POAG.

SOURCE: Cano J, Rahimi M, Xu BY, et al. Relationship between macular vessel density and total retinal blood flow in primary open-angle glaucoma. J Glaucoma 2021; May 12. [Epub ahead of print].




Early Predictive Factors of Visual Loss in nAMD Under Anti-VEGF: The GEFAL Study

Investigators evaluated early predictive factors of visual loss in individuals treated with anti-vascular endothelial growth factor injections under an as-needed regimen for neovascular age-related macular degeneration.

The post-hoc analysis of the randomized controlled trial GEFAL comparing ranibizumab and bevacizumab for neovascular AMD in 393 patients age 50 and older with neovascular AMD was based on one-year data from individuals included in the study.

Patients were put into one of three categories according to the BCVA change at three months (M3) and one year:
   1) patients with no vision loss ≥5 letters at M3 and at one year (absence of loss ≥5-letters);
   2) patients with no vision loss ≥5-letters at M3 but loss ≥5 letters at one year (secondary loss ≥5 letters); and
   3) patients with vision loss ≥5 letters at M3 and one year (initial loss ≥5 letters). The threshold of at least five letters lost indicated clinical significance.

The following factors were evaluated at baseline and at M3: age; sex; BCVA; presence of fluid; central macular thickness; angiographic choroidal neovascularization subtype; CNV area measured in disk area on fluorescein angiography; and the number of intravitreal injections.

Here were some of the findings:
• 225 patients (57.3 percent) didn’t lose ≥5 letters; a secondary loss of ≥5 letters after M3 was found in 109 patients (27.7 percent); and an initial loss of ≥5 letters of BCVA was found in 59 patients (15 percent).
• Baseline characteristics were comparable between the three groups except for the total CNV area, which was larger in the initial and the secondary loss groups (p=0.0412).
• At M3 a significant association was found between presence of subretinal fluid (p=0.0318) and vision loss of ≥5 letters, with an even stronger significant association between the presence of intraretinal fluid (p=0.0066) and vision loss of ≥5 letters.

Investigators found that a large CNV area at baseline was significantly associated with initial or secondary loss of visual acuity ≥5 letters despite anti-VEGF injections. They added that the presence of fluid, both subretinal and intraretinal at M3, was found in patients with poorer trajectories.

SOURCE: Kodjikian L, Rezkallah A, Decullier E, et al; GEFAL Study Group. Early predictive factors of visual loss at 1-year in neovascular age-related macular degeneration under anti-VEGF in the GEFAL study. Ophthalmol Retina 2021; May 12. [Epub ahead of print].


Complimentary CME Education Videos


DMEK Under Failed PK Without Host Descemetorhexis to Manage Secondary Graft Failure

Scientists looked at the safety and efficacy of the treatment of secondary graft failure in penetrating keratoplasty by performing Descemet’s membrane endothelial keratoplasty without host descemetorhexis.

The retrospective case series included eight eyes from eight individuals who underwent non-host Descemet’s membrane stripping DMEK surgery under a previously failed PK. The DMEK graft diameter was either matched or 0.25 to 0.5 mm undersized in relation to the PK diameter. Scientists reported six-month postoperative data; primary outcome measures were safety and anatomical success.

Here are some of the findings:
• No intraoperative complications were registered.
• Postoperatively, one case developed a PK host-donor junction dehiscence in relation to a previous early suture removal, requiring PK resuturing and DMEK rebubbling.
• Only one additional case required DMEK rebubbling.
• No primary graft failure was detected, and all cases achieved full PK transparency within two weeks.
• Corrected distance visual acuity improved from a median of counting fingers (CF-0.2) to 0.57 (0.05 to 0.7).
• Median central corneal thickness improved from 650.5 (497 to 897) to 464 (372 to 597) μm.
• Median endothelial cell density was 1,080 (581 to 2,043) cells/mm.
• Rebubbling rate (25 percent) was lower than that previously reported.
• All patients had extensive preoperative ocular comorbidity.

Scientists concluded that DMEK under PK without host descemetorhexis was a feasible surgical alternative for the treatment of graft failure after PK. It was associated with equivalent levels of efficacy and safety compared with Descemet’s membrane stripping DMEK techniques but simplified the surgical procedure and avoided potential intraoperative complications associated with Descemet’s stripping. The authors suggest that further studies with a larger sample and a longer follow-up are necessary to confirm their preliminary findings.

SOURCE: Alió Del Barrio JL, Montesel A, Ho V, et al. Descemet membrane endothelial keratoplasty under failed penetrating keratoplasty without host descemetorhexis for the management of secondary graft failure. Cornea 2020;39:1:13-17. [Epub ahead of print].


Intravitreal Conbercept for DME

Researchers evaluated the efficacy and safety of intravitreal injections of conbercept vs. laser photocoagulation in the treatment of diabetic macular edema.

A 12-month multicenter, randomized, double-masked, double-sham, parallel controlled, Phase III trial (Sailing Study) was followed by a 12-month open-label extension study. Patients with center-involved DME were randomly assigned to receive either laser photocoagulation followed by pro re nata sham intravitreal injections (laser/sham) or sham laser photocoagulation followed by PRN 0.5 mg conbercept intravitreal injections (sham/conbercept). Individuals who entered the extension study received PRN conbercept treatment. The primary endpoint was the change in best-corrected visual acuity from baseline.

A total of 248 eyes were included in the full analysis set, and 157 eyes continued in the extension study. Here are some of the findings:
• Significant improvement in mean change in BCVA from baseline to month 12 was observed in the sham/conbercept group (8.2 ±9.5 letters), whereas no improvement was observed in the laser/sham group (0.3 ±12 letters).
• Individuals in the laser/sham group showed a marked improvement in BCVA after the switch to conbercept in the extension study, and there was no difference in BCVA between the two groups at the end of the extension study.

Researchers reported that the use of a conbercept PRN intravitreal injection regimen improved the BCVA of DME patients, and its efficacy was better than that of laser photocoagulation, which was also observed when eyes treated with laser alone were switched to conbercept.

SOURCE: Liu K, Wang H, He W, et al. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol 2021 ; May 17. [Epub ahead of print].




Industry News

Coburn Introduces New HFC-1 Fundus Camera

Coburn Technologies introduced the HFC-1 Non-Mydriatic Fundus Camera, a new retinal camera manufactured by Huvitz, which the company says uses autodetection technology to produce sharp, quick and reliable images and measurements. Automated tracking and shooting allow the HFC-1 Fundus Camera to adjust modes on its own while measuring differing pupil sizes. Its 20-megapixel high-definition camera captures images with reduced motion artifacts and has the capability to enlarge images to study fine details, Coburn says. Users can measure, analyze, diagnose and produce reports using the camera’s built-in PC's 12.1” LCD touchscreen. Read more.

Genetic Test Helps Determine Patient’s Risk of Keratoconus and Presence of Other Corneal Dystrophies

Avellino Lab announced U.S. availability of AvaGen, The Genetic Eye Test, a test that “helps determine a patient’s risk of keratoconus and the presence of other corneal dystrophies.” The company says the test is designed to provide keratoconus patients with an earlier benefit from FDA-approved cross-linking treatment, which can halt disease progression and preserve vision. The AvaGen results can also influence the choice of refractive surgery options for patients, Avellino says. Read more.

GenSight Biologics Case Report Shows Visual Recovery after GS030 Treatment

GenSight Biologics announced the first case report of partial recovery of visual function in a blind patient with late stage retinitis pigmentosa. The subject is a participant in the ongoing PIONEER Phase I/II clinical trial of GenSight Biologics’ GS030 optogenetic therapy. GenSights says the paper in the May issue of Nature Medicine is the first peer-reviewed documentation of visual recovery for a blind patient treated with optogenetic therapy. Read more.


EyePoint Completes Enrollment of Phase I DAVIO Clinical Trial

EyePoint Pharmaceuticals completed patient enrollment of its Phase I clinical trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration. EYP-1901 is delivered via an intravitreal injection in the physician's office. The open-label 12-month dose escalation trial is examining wet AMD patients who were responsive to previous anti-VEGF therapies. Read more.



Novartis to Terminate Several Beovu Studies Due to Safety Issues

Novartis reported that it’s terminating its Phase III MERLIN study assessing the efficacy and safety of Beovu (brolucizumab) 6 mg vs. aflibercept 2 mg given every four weeks following the loading phase in patients with wet AMD who have persistent retinal fluid despite anti-VEGF therapy due to higher rates of intraocular inflammation in the Beovu patients.
When given every four weeks in MERLIN, the rate of intraocular inflammation, including retinal vasculitis and retinal vascular occlusion, was 9.3 percent with Beovu, versus 4.5 percent for aflibercept. The incidence of RV and RO for Beovu patients was 0.8 percent and 2 percent, respectively, versus no cases of either form of inflammation with aflibercept. The overall rate of vision loss (15 letters or more) due to all causes was 4.8 percent in the Beovu arm vs. 1.7 percent in the aflibercept arm. In terms of efficacy, the company says that Beovu met MERLIN’s primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline and superiority on select anatomical secondary endpoints at year one vs. aflibercept.
As a result of these adverse events, Novartis also stopped all of its other ongoing brolucizumab clinical programs assessing studies with four-week dosing intervals after the loading phase, stating, “Novartis has decided to terminate the MERLIN study and the RAPTOR and RAVEN studies, which were assessing the efficacy and safety of brolucizumab with six initial monthly injections in retinal vein occlusion. All other relevant ongoing trial protocols will be amended to discontinue four week dosing intervals after the loading phase. Clinical trial investigators have been informed and will appropriately follow-up with their patients. Physicians should not treat patients with Beovu 6 mg at intervals less than two months beyond the first three doses.” Read more.



New Data on Nanoscope's Optogenetic Gene Therapy

Nanoscope Therapeutics announced that vision improvements for all evaluated advanced retinitis pigmentosa patients persisted through one year following a single intravitreal injection in a Phase I/IIa clinical study with MCO. Nanoscope's RP gene therapy, which has received orphan drug designation from the FDA, uses a proprietary AAV2 vector to deliver the MCO genes into the retina. This mutation-independent gene therapy involves a single ocular injection administered in a doctor's office. Read more.

Johnson & Johnson Vision Expands "Sight For Kids" Program and Unveils New “Vision for Good” Community Impact Report

Johnson & Johnson Vision announced the expansion of nonprofit program Sight For Kids. Co-founded in 2002, the program is a collaboration between the company and Lions Clubs International Foundation to “close the gap in access to eye health for children in low income and underserved communities.” Learn more.

Eyenovia Announces Topline Results from VISION-1

Eyenovia announced that its VISION-1 study evaluating the company’s proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. The study is required for FDA approval and will serve as the basis for a planned New Drug Application submission. The VISION-1 study evaluated the safety and efficacy of Eyenovia’s 1% and 2% pilocarpine Micro-Array Print formulations vs. placebo, administered via the company’s proprietary Optejet dispenser. Read more.

Prevent Blindness to Host 10th Annual Focus on Eye Health National Summit Virtually

Prevent Blindness will host the 10th annual Prevent Blindness Focus on Eye Health National Summit virtually July 14 to 15. This year’s Summit will include a variety of presentations related to the theme “Our Changing Vision.” During the event, Prevent Blindness will formally present the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health to R.V. Paul Chan, MD, MSc, MBA, FACS, professor and head of the Department of Ophthalmology and Visual Sciences at the Illinois Eye and Ear Infirmary, University of Illinois at Chicago. Learn more.

B+L & Prevent Blindness Raising Awareness About Cataracts

Bausch + Lomb and Prevent Blindness joined forces for Cataract Awareness Month in June to educate the public and raise awareness about cataracts and cataract surgery. Visit Bausch + Lomb’s Facebook page.

New Amblyopia Treatment in Development

Luminopia One is working on a therapy for amblyopia for kids that uses a virtual reality headset. The treatment involves watching one hour per day of “therapeutically-modified” content that includes popular, mainstream kids’ programming. The therapy is under review with the FDA. Read about some of the findings here and here. Learn more.


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