Review of Ophthalmology Online



Vol. 20, #49   •   Monday, November 23, 2020


In this Issue:


Impact of Scotopic Microperimetric Sensitivity & Inner Choroid Flow Deficits on GA Progression

Researchers assessed the role of microperimetric retinal sensitivity and inner choroid flow deficits in predicting the development of incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) in intermediate AMD.

Thirty eyes with intermediate AMD evaluated at the Doheny-UCLA Eye Centers were enrolled in this prospective IRB-approved study. Subjects underwent several diagnostic tests:
• 6 × 6-mm swept-source optical coherence tomography angiography with the IC slab used to quantify flow deficits;
• 20 × 20-degree spectral-domain OCT to monitor progression to iRORA; and
• scotopic microperimetric retinal sensitivity within an area of 18 degrees centered on the fovea. All subjects were followed-up for 24 months. The baseline inner choroid flow deficits and microperimetric retinal sensitivity were correlated with the development of iRORA. At 24-month follow-up, the AMD stage was re-assessed, and eyes were divided into two subgroups based on iRORA development.

Twenty-eight eyes completed the two-year follow-up. At baseline, the mean microperimetric retinal sensitivity was 13.40 ±4.66 dB and the mean inner choroid flow deficit was 27.55 ±8.67 percent. The morpho-functional regression showed a significant correlation between baseline microperimetric retinal sensitivity and inner choroid flow deficits, and iRORA development within 24 months (R2=0.744; p<0.05). A Kaplan-Meier survival curve was fit to determine the cumulative incidence of iRORA over the 24 months..

Researchers reported that a lower microperimetric retinal sensitivity and greater inner choroid flow deficits at baseline were predictors of progression to iRORA in intermediate AMD eyes. They added that these parameters may be useful biomarkers for risk stratification and prognostication.

SOURCE: Corradetti G, Tiosano L, Nassisi M, et al. Scotopic microperimetric sensitivity and inner choroid flow deficits as predictors of progression to nascent geographic atrophy. Br J Ophthalmol 2020; Nov 10. [Epub ahead of print].



Outcomes of Epithelium-on and -off Accelerated Corneal CXL

Investigators compared the visual and tomographic outcomes of epithelium-on and epithelium-off corneal collagen crosslinking in an accelerated protocol in eyes with progressive keratoconus.

Sixty-one patients with progressive keratoconus (female patients, n=30), ages 17 and 48 years (mean age: 25.8 ±6.2 years), were included in this study. Patients underwent epithelium-off (n=27) or -on (n=34) CXL using an accelerated protocol. Patients with at least 12 months of follow-up were included. Visual and tomographic data from three, six and 12 months after surgery were analyzed.

Here were some of the findings:
• No differences were found between visual and tomographic characteristics of the epithelium-on and epithelium-off groups at baseline (p>0.05).
• No significant changes in uncorrected and best spectacles-corrected visual acuity were found at any stage during the first 12 months within or between groups (all p>0.05).
• No changes were found in thickness or keratometric parameters at any stage during the first 12 months within or between groups (p>0.05), except for a transient significant thinning of the central cornea in all groups in the first three months, which recovered by six months.
• No significant differences were found between the groups regarding the number of eyes with progression in the 12 months after treatment (p>0.05).

Investigators wrote that epithelium-on and -off CXL in an accelerated protocol provided comparable visual and tomographic outcomes after one year in eyes with progressive keratoconus.

SOURCE: Niyazmand H, McKelvie J, Li Y, et al. Comparison of visual and tomographic outcomes of epithelium-on and epithelium-off accelerated corneal crosslinking: A longitudinal study. Cornea 2020; Oct 19. [Epub ahead of print].



Effect of Suspended Scattering Particles & OCTA Vessel Density on DME

Scientists studied the effect of suspended scattering particles in motion (SSPiM) on optical coherence tomography angiography vessel density metrics in eyes with diabetic macular edema.

Thirty-four eyes with DME from 27 patients (16 males and 11 females, 61.4 ±9.6 years) with DME were included in this retrospective cohort study. Among these eyes, 19 (55.9 percent) showed the SSPiM artifact on OCTA. All participants underwent 3- and 6-mm OCTA. Perfusion density and skeletonized vessel density were calculated for the superficial capillary plexus (SCP) and deep capillary plexus (DCP), and compared between eyes with and without SSPiM. Additionally, foveal vessel density in a 300-µm-wide region around the foveal avascular zone (FAZ) was evaluated on 3-mm OCTA scans. The main outcome measures were vessel density in the SCP and the DCP.

Here were some of the findings:
• Among the 3-mm OCTA images, no statistically significant difference was found in SCP vessel density in eyes with and without SSPiM (p=0.98).
• Vessel density in the DCP (p=0.001 and p=0.028 for perfusion and skeletonized vessel density, respectively) and FAZ (p=0.03) on 3-mm OCTA scans was significantly higher in DME eyes with SSPiM.
• No statistically significant differences were found in SCP and DCP vessel density between eyes with and without SSPiM, based on 6-mm OCTA scans.

Scientists determined that the presence of suspended scattering particles in motion led to an overestimation of DCP vessel density in eyes with DME when 3-mm OCTA scans were used for analysis.

SOURCE: Maltsev DS, Kulikov AN, Kazak AA, et al. Suspended scattering particles in motion may influence optical coherence tomography angiography vessel density metrics in eyes with diabetic macular edema. Retina 2020; Oct 30. [Epub ahead of print].


Complimentary CME Education Videos


Glaucoma Drainage Surgery After Penetrating Keratoplasty: Ten-year Outcomes

Researchers wrote that, in eyes with intractable glaucoma, drainage devices provide long-term control of intraocular pressure after penetrating keratoplasty; however, there is a high incidence of corneal graft failure. They aimed to compare long-term results of eyes with glaucoma drainage device after PK.

Researchers retrospectively reviewed medical records of patients who underwent glaucoma drainage device placement after PK at their institution between 2001 and 2017. Forty eyes of 40 patients were studied. Glaucoma outcomes were assessed by postoperative intraocular pressure, number of medications and need for further glaucoma surgery. Corneal outcomes were assessed by graft rejection, failure and visual acuity. Surgical procedures before and during the study period, and their complications were evaluated.

Here were some of the findings:
• The mean follow-up was 125 ±52.3 months (median: 116.5).
• Twenty of 40 eyes had a follow-up of at least 10 years.
• The mean preoperative IOP was 34 ±8.3 mmHg (median: 32) with 3.2 ±1.3 glaucoma medications (median: 3.5).
• At the last follow-up, the mean IOP decreased to 12.7 ±4.9 mmHg (median: 14) with 1 ±1.2 glaucoma medications (median: 0).
• Glaucoma drainage device implantation successfully controlled glaucoma in the following percentages of eyes:
   o 88 percent at one year;
   o 88 percent at two years;
   o 85 percent at three years;
   o 80 percent at four years;
   o 78 percent at five years;
   o 75 percent at seven years; and
   o 70 percent of eyes at 10 years.
• At last follow-up, 68 percent showed glaucoma success.
• The corneal grafts remained clear in:
    o 74 percent at one year;
    o 63 percent at two years;
    o 45 percent at three years;
    o 45 percent at four years;
    o 37 percent at five years;
    o 32 percent at seven years; and
    o 26 percent of eyes at 10 years.
• Only seven corneal grafts (17.5 percent) remained clear at last follow-up.

Researchers wrote that a glaucoma drainage device could successfully control intractable glaucoma after a long period of time, including after PK. However, they added, the survival of the corneal grafts was low.

SOURCE: Purtskhvanidze K, Saeger M, Frimpong-Boateng A, et al. Ten-year outcome of glaucoma drainage device surgery after penetrating keratoplasty. J Glaucoma 2020; Nov 11. [Epub ahead of print].






Industry News

Gemini Announces Phase I Study Results

Gemini Therapeutics announced the small-scale Phase I study of GEM103, the company’s investigational treatment for dry age-related macular degeneration, met all endpoints. Results demonstrated that, in 12 patients receiving a single intravitreal injection of GEM103, no dose-limiting toxicities or treatment-related adverse events were reported. The results were presented during a virtual poster session at the 2020 American Academy of Ophthalmology virtual meeting. Read more.



Investigational RPGR Therapy in X-linked RP Patients

The Janssen Pharmaceutical Companies of Johnson & Johnson announced 12-month data from the ongoing Phase I/II trial of an investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa. They say that the results show that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement. Data on the novel adeno-associated virus retinitis pigmentosa GTPase regulator, jointly developed with MeiraGTx Holdings, were presented at the American Academy of Ophthalmology virtual meeting. Read more.



Topcon Announces U.S. Launch of Chronos

Topcon Healthcare launched the Chronos Automated Binocular Refraction System with SightPilot guided refraction software. The digital refraction solution combines autorefraction, keratometry and subjective refraction in a single device that occupies less than four feet of space. SightPilot, a fully automated system, features guided refraction software designed to be easily operated by anyone in the practice, the company says. Binocular testing means refractions can take as little as three-and-a-half minutes, Topcon says. Read more.



Lineage Presents New OpRegen Data for Dry AMD with GA

Lineage Cell Therapeutics announced positive interim results from the ongoing 24-patient Phase I/IIa clinical study of the company’s therapy, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space for the treatment of dry age-related macular degeneration with geographic atrophy. At the American Academy of Ophthalmology virtual meeting, the company says that data showed improvements in visual acuity in cohort-four patients, with treated vs. fellow eye comparisons reaching statistical significance at nine and 12 months. Read more.



Kodiak Completes Enrollment of DAZZLE Phase IIb/III KSI-301 Study

Kodiak Sciences announced that recruitment concluded in its DAZZLE pivotal study of KSI-301, an anti-VEGF antibody biopolymer conjugate, in patients with neovascular age-related macular degeneration. Read more.



Novartis Reports Data & Post-hoc Analysis of Beovu Trials

Novartis reported initial findings from a coalition convened to answer key questions related to treatment with Beovu (brolucizumab) for adults with wet age-related macular degeneration. Analyses of U.S. real-world and Phase III data presented at the American Academy of Ophthalmology virtual meeting identified baseline patient characteristics potentially associated with the incidence of inflammation-related adverse events that may occur following treatment with Beovu. Novartis says it has a comprehensive program under way to examine the root cause and potential risk factors for these events, and to identify mitigation strategies and treatment protocols. Read more.



Innovent Announces Phase I IBI302 Trial Results

Innovent Biologics announced at the American Academy of Ophthalmology virtual meeting that IBI302, the company’s recombinant human anti-VEGF and anti-complement bi-specific fusion protein for neovascular AMD, demonstrated good safety and tolerability in a Phase I clinical trial. Read more.



Adverum Announces Interim Data from OPTIC Phase I Trial

Adverum Biotechnologies announced positive new interim data from cohorts one to four in the OPTIC Phase I clinical trial of ADVM-022 intravitreal injection gene therapy in individuals requiring frequent anti-VEGF injections for wet AMD. Adverum says the therapy continues to maintain efficacy at high and low doses. Read more.











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