From the editors of Review of Ophthalmology and Retina Specialist
THE LATEST PUBLISHED RESEARCH
WELCOME to Review of Ophthalmology's Retina Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.
Ranibizumab and Polypoidal Choroidal Vasculopathy
Investigators evaluated the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive individuals with and without polypoidal choroidal vasculopathy.
They assessed neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the Novartis-sponsored LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events. Here are some of the findings:
• At baseline, 572 individuals were diagnosed with PCV, and 5,644 patients were diagnosed without PCV.
• The mean visual acuity gain from baseline at month 12 in the PCV group was +5 letters, and the mean visual acuity gain from baseline at month 12 in the non-PCV group was +3 letters; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections in the PCV and non-PCV groups, respectively.
• Eighty percent of PCV patients, and 72.2 percent of non-PCV individuals who had baseline visual acuity ≥73 letters maintained this level of vision at month 12; 20.6 percent of PCV patients and 17.9 percent of non-PCV patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups.
• Greater reductions in central retinal thickness from baseline were also observed for the PCV group vs. the non-PCV group.
• The rate of serious ocular adverse events was 0.7 percent (PCV group) and 0.9 percent (non-PCV group).
Investigators wrote that LUMINOUS confirmed the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.
SOURCE: Koh A, Lai TYY, Wei WB, et al. Real-world effectiveness and safety of ranibizumab treatment in patients with and without polypoidal choroidal vasculopathy: Twelve-month results from the LUMINOUS study. Retina 2019; Aug 2. [Epub ahead of print].
Treat-and-extend vs. PRN Regimens of Ranibizumab & Aflibercept in nAMD
In a retrospective, observational study, investigators compared the treatment efficacy of anti-VEGF medications following pro re nata (monthly injections only in case of active disease) or treat-and-extend (progressive extension of treatment intervals up to 12 weeks depending on the clinical findings) treatment protocols in real-world conditions.
Individuals diagnosed with age-related macular degeneration and without pre-treatment undergoing routine anti-VEGF treatment in a Swiss eye clinic were included. Treatment was performed according to local practices, using ranibizumab or aflibercept and following T&E or PRN regimens. Investigators evaluated changes in logMAR and injection intervals (time between two injections) for specific treatment periods descriptively and using mixed models.
A total of 1,071 individuals with 1,332 treated eyes (722 PRN ranibizumab, 191 T&E ranibizumab, 419 T&E aflibercept) were included in the analyses. Here were some of the findings:
• At baseline, logMAR visual acuity was similar in both ranibizumab treatment groups (PRN: 0.63 ±0.43; T&E: 0.57 ±0.42).
• In the PRN ranibizumab group, logMAR acuity was about 0.1 lower for all time intervals in the initial and maintenance phases compared with baseline, indicating an improvement in VA.
• By comparison, acuity improved more strongly in the T&E ranibizumab group (16 to <22 months, - 0.19 [-0.23 to 0.15]) compared with baseline.
• Comparing T&E ranibizumab vs. T&E aflibercept groups, improvements in acuity were similar over time.
• In the maintenance phase, the rate of individuals with a clinically relevant improvement in visual acuity (>0.2 logMAR) was higher in both T&E groups compared with the ranibizumab/PRN group.
• Injection intervals in the maintenance phase in the T&E ranibizumab group gradually expanded over time, while in the T&E aflibercept group, injection intervals remained relatively stable.
Investigators determined that using ranibizumab according to a T&E protocol yielded a stronger improvement in logMAR acuity compared with a PRN protocol with longer injection intervals than T&E aflibercept. They added that this large real-world data assessment supported previous data on the superiority of T&E treatment.
SOURCE: Augsburger M, Sarra GM, Imesch P. Treat and extend versus pro re nata regimens of ranibizumab and aflibercept in neovascular age-related macular degeneration: A comparative study. Graefes Arch Clin Exp Ophthalmol 2019; June 29. [Epub ahead of print].
AREDS2 Report 20: Prevalence, Risk and Genetic Association of Reticular Pseudodrusen in AMD
Researchers determined the prevalence of reticular pseudodrusen (RPD) in eyes with age-related macular degeneration to assess the role of RPD as an independent risk factor for late AMD development, and evaluated genetic associations with RPD, as part of a prospective cohort study. Participants included individuals with intermediate AMD in one or both eyes enrolled in the Age-Related Eye Disease Study 2 (AREDS2).
Fundus autofluorescence images from a subset of AREDS2 participants were evaluated at annual visits for presence of RPD. Six single nucleotide polymorphisms (SNPs): rs10490924 (ARMS2), rs1061170 (CFH), rs2230199 (C3), rs116503776, rs114254831 (C2/CFB) and rs943080 (VEGF-A) and genetic risk scores (GRS) were assessed for associations with RPD. Development of late AMD, defined as geographic atrophy or neovascular AMD (NVAMD) was identified. Researchers conducted multivariate repeated measures logistic regression.
Main outcome measures included prevalence of RPD, the odds ratio of late AMD development and genetic associations of RPD. FAF images were evaluated for 5,021 eyes (2,516 participants). RPD was seen in 1,186 (24 percent of eyes, 29 percent of participants). Here were some of the findings:
• RPD prevalence varied with baseline AREDS AMD severity level for the eye: 6 percent in early AMD (n=458), 26 percent in intermediate AMD (n=2,606), 36 percent in GA (n=682) and 19 percent in NVAMD (n=1,246).
• The mean age of participants with RPD was 79 ± 7 years compared with 75 ± 8 years in those without (p<0.0001).
• RPD was more common in females (65 percent RPD vs. 53 percent no RPD).
• The odds ratio adjusted for baseline age, gender, race, educational status, smoking and AMD severity level for 1,710 eyes at risk of developing late AMD at the next annual visit was 2.42 (CI, 1.80, 3.24, p<0.001) for GA and 1.21 (CI, 0.87 to 1.7; p=0.26) for NVAMD.
• RPD presence was significantly associated, at a Bonferroni-adjusted significance level of 0.007, with higher GRS (p<0.0001) and ARMS2 risk alleles (rs10490924; p<0.0001); and, at a nominal level, with C3 risk alleles (rs2231099; p=0.04) and CFH risk alleles (rs1061170; p=0.048 for homozygotes).
Researchers found that participants with RPD had an increased risk of progression to GA but not NVAMD. ARMS2 risk alleles and higher GRS were associated with the presence of RPD. Researchers wrote that the findings suggested that RPD were an important risk marker and should be included in classification systems used for patient prognosis.
Source: Domalpally A, Agron E, Pak JW, et al. Prevalence, risk and genetic association of reticular pseudodrusen in age-related macular degeneration. AREDS2 Report 20. Ophthalmology 2019; July 19. [Epub ahead of print].
Pseudodrusen Pattern & Development of Late AMD in Fellow Eyes of Unilateral Cases
Investigators assessed whether the development of late age-related macular degeneration in fellow eyes with pseudodrusen was associated with the pseudodrusen pattern in individuals with unilateral exudative AMD, as part of a retrospective, observational study.
They performed a retrospective analysis on 73 individuals with unilateral exudative AMD showing pseudodrusen in their fellow eyes. Eyes were classified according to pseudodrusen pattern, which was determined based on maximum pseudodrusen ribbon length. Here were some of the findings:
• During the mean follow-up period of 35.5 ±18.6 months, 21 (28.8 percent) eyes developed late AMD.
• Among these eyes, 15 (71 percent) developed exudative AMD and six (29 percent) developed geographic atrophy.
• Development of late AMD in fellow eyes occurred with significantly more prevalence in individuals showing a ribbon-dominant type of pseudodrusen pattern in their fellow eye than a dot-dominant type (p=0.0005, log-rank test).
• Cox-regression analysis revealed that development of late AMD in fellow eyes was associated with the presence of ribbon-dominant pseudodrusen in fellow eyes (HR, 4.15; CI, 1.59 to 10.8), along with older age (HR, 1.10; CI, 1.03 to 1.17), a history of smoking (HR, 17.2; CI 1.11 to 263), presence of large soft drusen in the fellow eye (HR, 5.49; CI, 1.29 to 21.1) and retinal angiomatous proliferation (HR, 5.02; CI, 1.90 to 13.2).
Researchers determined that individuals with unilateral exudative AMD who had fellow eyes with ribbon-dominant pseudodrusen were likely to develop late AMD.
SOURCE: Sakurada Y, Sugiyama A, Kikushima W, et al. Pseudodrusen pattern and development of late age-related macular degeneration in the fellow eye of the unilateral case. Jpn J Ophthalmol 2019; Jul 2. [Epub ahead of print].
Prognostic Implications of Hyperreflective Crystalline Deposits in Non-neovascular AMD
Researchers explored patterns of disease progression in non-neovascular age-related macular degeneration associated with hyperreflective crystalline deposits (HCDs) in the subretinal pigment epithelium-basal laminar space, as part of a retrospective medical records review of multimodal imaging; longitudinal eye-tracked, near-infrared reflectance (NIR); and optical coherence tomography spanning ≥2 years.
NIR/OCT images were analyzed with ImageJ software to identify HCD morphology and location. Researchers reviewed associated macular complications from HCD detection to the most recent follow-up, using NIR/OCT. Thirty-three eyes with HCDs from 33 individuals (mean age: 72 ±7.5 years) had 46.7 months (CI, 33.7, 59.6) of serial eye-tracked NIR/OCT follow-up. Here are some of the findings:
• Baseline best-corrected visual acuity was 0.44 logMAR (Snellen equivalent 20/55).
• At a mean of 11.3 months (3.1, 19.6) after HCD detection, 31/33 (93.9 percent) eyes had developed macular complications including de novo areas of complete retinal pigment epithelium and outer retinal atrophy (cRORA) in 21/33 (64 percent) eyes, enlargement of preexisting cRORA in 4/33 (12 percent) eyes and incident macular neovascularization in 3/33 (9 percent) eyes.
• Movement and clearance of HCDs in 9/33 (27 percent) eyes was associated with enlargement of preexisting cRORA (r=0.44, p=0.02). BCVA at the last follow-up visit had decreased to 0.72 logMAR (20/105).
Researchers concluded that eyes with non-neovascular AMD demonstrating HCDs were at risk for vision loss due to macular complications, particularly when movement and clearance of such structures appeared on multimodal imaging. They added that HCD reflectivity and dynamism might be amenable to automated recognition and analysis to assess cellular activity related to drusen end stages.
SOURCE: Fragiotta S, Fernández-Avellaneda P, Breazzano MP, et al. The fate and prognostic implications of hyperreflective crystalline deposits in nonneovascular age-related macular degeneration. Invest Ophthalmol Vis Sci. 2019;60:8:3100-9.
Longitudinal Changes in the Peripapillary RNFL Thickness of Type 2 Diabetics
Scientists wrote that type 2 diabetes is expected to accelerate age-related peripapillary retinal nerve fiber layer loss, but limited information on the rate of reduction in pRNFL thickness in individuals with type 2 diabetes is available. As such, they looked at longitudinal changes in pRNFL thickness in individuals with type 2 diabetes, with or without diabetic retinopathy.
A total of 164 eyes of 63 healthy individuals, and 101 individuals with type 2 diabetes (49 people without DR, and 52 people with mild-to-moderate nonproliferative DR) were enrolled in the prospective, longitudinal, observational study betwen Jan. 2, 2013, and Feb. 27, 2015. Participants were followed for three years, and the peripapillary mean and sector RNFL thickness were measured at one-year intervals. Scientists estimated the mean rate of pRNFL loss using a linear mixed model and compared it among the three groups. Follow-up was completed on March 16, 2018, and data was analyzed from April 2, 2018, through July 27, 2018.
Main outcomes and measures included the rate of reduction in pRNFL thickness in individuals with type 2 diabetes. A total of 164 participants (88 women [53.7 percent]; mean age: 58.2 ±8.7 years) were included in the study analysis. The mean age of the control group was 56.5 ±9.3 years (39 women [61.9 percent]); the non-DR group, 59.1 ±9.4 years (26 women [53.1 percent]); and the NPDR group, 59.4 ±11 years (23 women [44.2 percent]). Here were some of the findings:
• The mean duration of type 2 diabetes was 7.1 ±4.4 years in the non-DR group and 13.2 ±8.4 years in the NPDR group.
• The baseline mean pRNFL thickness was 96.2 ±11 μm in the control group, 93.5 ±6.4 μm in the non-DR group and 90.4 ±7.9 μm in the NPDR group.
• During three years of follow-up, these values decreased to 95 ±9.2 μm in the control group, 90.3 ±6.4 in the non-DR group and 86.6 ±7.9 μm in the NPDR group.
• In a linear mixed model, the estimated mean pRNFL loss was -0.92 μm/y in the non-DR group (p<0.001) and -1.16 μm/y in the NPDR group (p<0.001), which was 2.9-fold (CI, 1.1 to 14.8; p=0.003) and 3.3-fold (CI, 1.4 to 18; p<0.001) greater, respectively, than that of the control group (-0.35 μm/y; p=0.01).
Scientists observed a progressive reduction of pRNFL thickness in healthy controls and individuals with type 2 diabetes without and with DR; however, type 2 diabetes was associated with a greater loss of pRNFL, regardless of whether DR was present. Scientists wrote that the findings suggested that pRNFL loss might occur in people with type 2 diabetes even in the absence of DR progression.
SOURCE: Lim HB, Shin Y, Lee MW, et al. Longitudinal changes in the peripapillary retinal nerve fiber layer thickness of patients with type 2 diabetes. JAMA Ophthalmol 2019; Jul 25. [Epub ahead of print].
DME Severity Correlates with Retinal Vascular Bed Area on Ultra-widefield FA
Researchers quantified retinal nonperfusion area and retinal vascular bed area (RVBA) in mm2 on ultra-widefield fluorescein angiography in eyes with diabetic macular edema and assessed the relationship with DME severity, as part of a prospective, observational case series.
Baseline ultra-widefield fluorescein angiography images of 40 eyes from 29 individuals with treatment-naive DME who participated in the DAVE study, which was completed in May 18, 2017, were stereographically projected at the Doheny Image Reading Center. Researchers automatically extracted the retinal vasculature to calculate RVBA. Two masked, certified graders manually delineated the nonperfusion area. The retinal vascular bed area and nonperfusion area in mm2 were automatically computed by adjusting for peripheral distortion, and then correlated with DME severity.
The global RVBA for the entire retina in eyes with DME was increased compared with healthy controls (54.7 ±16.6 mm2 vs. 37.2 ±9.9 mm2, p<0.001) and correlated with the severity of DME (p<0.05). Retinal ischemia (nonperfusion area) was nonuniformly distributed and not related to DME extent (p>0.05).
Researchers determined that DME eyes had an increased RVBA compared with healthy controls. They added that DME severity appeared to be related to global RVBA, but not to retinal ischemia.
SOURCE: Fan W, Uji A, Wang K, et al. Severity of diabetic macular edema correlates with retinal vascular bed area on ultra-wide field fluorescein angiography. Retina 2019; July 26. [Epub ahead of print].
Anti-VEGF vs. Dexamethasone Implant for Center-involved DME
Researchers compared the efficacy and safety of intravitreal anti-vascular endothelial growth factor injection vs. dexamethasone implant (Ozurdex) for the treatment of center-involved DME.
This prospective, randomized, comparative study included 40 eyes (38 individuals) with center-involved DME. Researchers randomized subjects into two groups: Individuals in group A received the intravitreal anti-VEGF injection (bevacizumab 1.25 mg or ranibizumab 0.5 mg) after four weeks, and those in group B received the dexamethasone implant (0.7 mg) pro re nata after three months. The primary outcome, measured at three months from baseline, included improvement in BCVA, reduction in CFT and adverse effects during follow-up. Here are some of the findings:
• Mean best-corrected visual acuity improved from 0.51 ±0.275 logMAR units (20/63) to 0.20 ±0.185 logMAR units (20/32) in group A, and from 0.56 ± 0.213 logMAR units (20/80) to 0.141 ±0.177 logMAR units (20/32) in group B at three months.
• There was no significant difference in mean BCVA between both groups (p=0.27).
• The mean central foveal thickness improved from 443.55 ±131.536 µm to 277.66 ±76.184µm in group A, and from 460.95 ±125.462 µm to 233.25 ±37.552 µm at three months in group B (p=0.02).
Researchers determined that both groups had similar visual outcomes. However, they noted that the superior anatomical result was observed in the dexamethasone implant group during this short follow-up.
SOURCE: Sharma A, Bellala K, Dongre P, et al. Anti-VEGF versus dexamethasone implant (Ozurdex) for the management of centre involved diabetic macular edema (CiDME): A randomized study. Int Ophthalmol 2019; Aug 3. [Epub ahead of print].
Characterizing Retinal-Choroidal Anastomosis in MacTel 2 with OCTA
Scientists characterized structural and angiographic findings in macular telangiectasia Type 2 and examined associations with visual acuity. They retrospectively evaluated MacTel 2 patients with ophthalmologic exams including fundus photography, autofluorescence, spectral-domain optical coherence tomography and projection-resolved optical coherence tomography angiography.
A total of 43 eyes of 22 individuals had a mean age 63.9 ±10.3 years. Here were some of the findings:
• Six individuals had diabetes.
• Twenty-one eyes (48.8 percent) had retinal-choroidal anastomoses without any evidence of neovascularization extending laterally in a plane above or below the retinal pigment epithelium.
• No eyes had hemorrhages, lipids or signs of subretinal exudation.
• When present, an average of 55 ±33.7 individual RCAs were clustered primarily in temporal juxtafoveal region of involved eyes.
• Right-angle veins were seen in all 21 eyes with RCAs, and hyperpigmentation was present in 18 (p<0.001 for both).
• Scientists found a conical collection of hyperreflective material spanning from Bruch’s membrane past the external limiting membrane of ≥200-μm basal diameter in 21 eyes and labeled it as outer retinal hyperreflective lesion.
• Retinal-choroidal anastomoses occurred in clusters, often within the outer retinal hyperreflective lesion.
• The outer retinal hyperreflective lesion colocalized with focal thinning of the outer nuclear layer and was surrounded by a larger defect in the ellipsoid zone.
• The presence of diabetes (p=0.015), outer retinal hyperreflective lesion (p=0.006), RCA (p=0.005) and ellipsoid zone defect extent (p<0.001) were associated with decreased visual acuity.
Scientists wrote that retinal-choroidal anastomoses occurred in eyes with MacTel 2 without signs of exudation. In addition, they reported that retinal-choroidal anastomoses occurred in numerous clusters, particularly in the temporal juxtafoveal macula; and that diabetes, ellipsoid zone defect extent, RCAs and the outer retinal hyperreflective lesion predicted poorer vision in MacTel 2.
SOURCE: Breazzano MP, Yannuzzi LA, Spaide RF. Characterizing retinal-choroidal anastomosis in macular telangiectasia type 2 with optical coherence tomography angiography. Retina 2019; Jun 25. [Epub ahead of print].
Morphological Changes of Focal Choroidal Excavation
Scientists evaluated morphological changes of focal choroidal excavation, as part of a retrospective review of the medical records of 18 FCE individuals (25 eyes). They analyzed clinical features and images of the ocular fundus, fundus fluorescein angiography, indocyanine green angiography and spectral-domain optical coherence tomography. And they used OCT images as a major criterion to evaluate changes that occurred during follow-up.
Of 18 individuals (nine male, nine female), the mean age was 41 ±13.5 years. The follow-up period was 38.5 ±24.7 (seven to 92) months. Here were some of the findings:
• Thirteen patients were myopic.
• FCE appearance ranged from a slight pigment irregularity to a yellowish white plaque.
• FFA revealed window defects corresponding to the lesions.
• Early-phase ICGA images showed hypofluorescence and medium to large choroidal blood vessels.
• Plaque- or dot-like hyperfluorescence was seen on late-phase images.
• OCT scans showed that 11 individuals had unilateral FCE, and seven patients were bilaterally affected.
• Twenty-three eyes had a single FCE, and the other two eyes had two excavations.
• FCE presented as the confirming type in 21 eyes and non-confirming type in three eyes.
• Investigators found discontinuity of the interdigitation zone, ellipsoid zone and retinal pigment epithelium/Bruch’s complex zone.
• The average subfoveal choroidal thickness was 312.06 ±66.12 μm in FCE eyes.
• During follow-up, choroidal neovascularization developed in four individuals, and retinal pigment epithelium discontinuity was aggravated in one eye.
• No remarkable changes were found in the other eyes on B scans of the OCT images, but the volume of FCE might have changed slightly.
Investigators reported that FCE, both confirming type and non-confirming type, might remain stable during a long period of time. They added that choroidal neovascularization could develop at the site of FCE.
Source: Zheng-Yu C, Lei S, Wen-Bin W. Morphological changes of focal choroidal excavation. Graefes Arch Clin Exp Ophthalmol 2019; Jul 4. [Epub ahead of print].
Opthea Meets Primary Endpoint in Phase IIb Study of OPT-302 in Wet AMD
Opthea announced positive Phase IIb results demonstrating that OPT-302 combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to Lucentis monotherapy in treatment-naïve individuals with wet age-related macular degeneration. The Phase IIb, randomized, double-masked, sham-controlled clinical trial recruited 366 wet AMD individuals who were allocated to two intravitreal doses of OPT-302 (0.5 mg and 2 mg), administered monthly in combination with 0.5-mg Lucentis over 24 weeks, vs. a control group that received standard-of-care 0.5-mg Lucentis administered monthly. Read more.
SOURCE: Opthea, August 2019
FDA Approves Eylea (Aflibercept) Injection Prefilled Syringe
Regeneron announced the FDA approved the Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea (aflibercept) Injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer Eylea that requires fewer preparation steps compared with vials. Market supply of the prefilled syringe is expected to be available to physicians and patients this year. Read more.
SOURCE: Regeneron Pharmaceuticals, August 2019
RESEARCH TO PREVENT BLINDNESS & AAO AWARD GRANTS FOR BIG DATA RESEARCH
The American Academy of Ophthalmology and Research to Prevent Blindness announced this year’s recipients of the Research to Prevent Blindness/American Academy of Ophthalmology Award for IRIS Registry Research. The grant supports researchers who want to conduct big data research in ophthalmology and blindness prevention. These four clinical researchers were selected based on the potential of their original research to advance the Academy’s mission of improving patients’ lives through research and innovation.
• Rishi Singh, MD, Cole Eye Institute, Cleveland Clinic, assistant professor of ophthalmology, Lerner College of Medicine
• Thomas M. Lietman, MD, professor, University of California, San Francisco School of Medicine
• Jennifer Elizabeth Thorne, MD, PhD, professor, Wilmer Eye Institute, Johns Hopkins Bloomberg School of Public Health
• Subhash Aryal, PhD, associate professor, biostatistics & epidemiology, UNT Health Science Center.
SOURCE: American Academy of Ophthalmology, Research to Prevent Blindness, July 2019
MACULAR DEGENERATION PANEL RECOMMENDS PARADIGM SHIFT
A panel of 12 investigators assembled by the National Advisory Eye Council called for large-scale collaborative research to address dry macular degeneration. The group recognized the need to investigate the state of research on the disease to guide the direction of future studies in an article published in Nature Communications. Among the ideas proposed were: soliciting integrated collaboration among leading clinicians, imaging experts, basic scientists, bioinformaticians and biostaticians; creating a large biorepository of eye tissue from donors with and without AMD; generating various types of data from disease and normal eye tissue; and designing computer models of the disease. Read more.
SOURCE: Boston University School of Medicine, August 2019
Scientists Further Our Understanding of Dry AMD
Scientists at Trinity College announced a discovery with implications for dry age-related macular degeneration. The researchers discovered that a key component of the cells lining the retinal blood vessels, claudin-5, might be central to the development of AMD. In pre-clinical models, they found that “leaky blood vessels” pre-disposed the eye to developing features of AMD. Researchers said that regulating the integrity of the retina’s blood vessels might, over time, help prevent the development of dry AMD. Read more.
SOURCE: Trinity College Dublin, August 2019
UNIV. OF LOUISVILLE RESEARCHERS DISCOVER CAUSE OF VISION LOSS IN HEREDITARY EYE DISORDER
Researchers at the University of Louisville discovered that loss of vision in retinitis pigmentosa is likely the result of a disruption in the flow of glucose to the rods and cones, leading to starvation of the photoreceptors. In research published in Cell Reports, the researchers described metabolic changes resulting in the reduced availability of glucose in the cells. As research illuminates a better understanding of RP progression, this knowledge may lead to therapies that could slow or stop this process before the rods and cones are destroyed. Read more.
Source: UofL News, July 2019
ALLERGAN AND EDITAS MEDICINE INITIATE PHASE I/II CLINICAL TRIAL OF AGN-151587
Allergan and Editas Medicine, a genome editing company, announced that the Brilliance Phase I/II clinical trial of AGN-151587 (EDIT-101) is open for patient enrollment. AGN-151587 is an experimental medicine under development for the treatment of Leber’s congenital amaurosis 10 (LCA10), an inherited form of blindness caused by mutations in the CEP290 gene. The clinical trial will be the world’s first in vivo study of a CRISPR-based genome editing medicine, where the editing takes place inside the human body. The Brilliance clinical trial will evaluate AGN-151587 for the treatment of LCA10. The study will assess safety, tolerability, and efficacy in approximately 18 patients. Read more.
SOURCE: Editas Medicine and Allergan, July 2019
IVERIC BIO ADVANCES LCA10 MINIGENE PROGRAM & EXPANDS ORPHAN GENE THERAPY PORTFOLIO
IVERIC bio entered into an agreement with the University of Massachusetts Medical School for rights to develop and commercialize mutation-independent, novel adeno-associated virus gene therapy product candidates for the treatment of Leber’s Congenital Amaurosis type 10 due to CEP290 gene mutations. The company also entered into a sponsored research agreement with UMass Medical School for rights to develop and commercialize novel AAV gene therapy product candidates using a mutation-independent minigene therapy approach for the treatment of vision loss in USH2A-related inherited retinal diseases. Read more.
SOURCE: IVERIC, July 2019
HILLROM INTRODUCES RETINAL IMAGER
Hillrom introduced the Welch Allyn RetinaVue 700 Imager handheld retinal camera as part of the RetinaVue Care Delivery Model, enabling remote ophthalmologists to diagnose diabetic retinopathy in individuals with diabetes during routine primary care office visits. The imager is the first handheld camera capable of capturing high-quality retinal images in a fully automated fashion in pupils as small as 2.5 mm, according to the company. With a 60-degree field of view and image-quality assessment algorithm, the imager enables users to efficiently review up to 75 percent more retinal area compared with cameras with a standard 45-degree field of view, the company says. The device includes Hillrom's HIPAA/HITECH-compliant RetinaVue Network, featuring encryption of data in transit and at rest, along with secure client-server authentication. Read more.
SOURCE: Hillrom, July 2019
SURVEY: RETINA SPECIALISTS POSITIVELY IMPACT TREATMENT FOR MACULAR DEGENERATION PATIENTS
A new survey from Health Union finds that people with macular degeneration who regularly see a retina or macular degeneration specialist for care have more satisfaction with their health-care professional relationships and treatment plans, and have a better grasp of their condition than those who regularly see other health-care providers. Of the survey's 461 respondents, 51 percent said they see a retina specialist or macular degeneration specialist most often for their condition. The findings from the survey, titled “Macular Degeneration in America 2019,” support the launch of Health Union’s MacularDegeneration.net, a condition-specific online community. Read more.
SOURCE: Health Union, July 2019
ZEISS RECEIVES CLEARANCE FOR CLARUS 700
Zeiss announced it received FDA 510(K) clearance for the CLARUS 700 high-definition, ultra-widefield imaging system. The system has true color and a complete range of fundus imaging modalities, including fluorescein angiography. The system’s high-resolution and high contrast FA images enable clinicians to capture minute details from the macula in early phases to the periphery in late phases of disease, the company says. Zeiss adds that the device captures images that closely resemble the natural coloration of the fundus as it appears under direct clinical observation. Read more.
Source: Zeiss Medical Technology, July 2019
CLEARSIDE ENTERS INTO LICENSE AGREEMENT WITH AURA BIOSCIENCES
Clearside Biomedical announced its entry into a worldwide licensing agreement with Aura Biosciences for the use of Clearside’s Suprachoroidal Space Microinjector to deliver Aura’s proprietary drug candidates into the SCS for the potential treatment of certain ocular cancers, including choroidal melanoma. Aura is developing a novel class of therapies, called viral nanoparticle conjugates, which are designed to selectively bind and eliminate cancer cells without damaging surrounding normal tissues. Read more.
Source: Clearside Biomedical, July 2019
EYENUK’S EYEART ARTIFICIAL INTELLIGENCE SYSTEM STUDIED
Eyenuk announced that the peer-reviewed journal Diabetes Technology and Therapeutics published a study in the Aug. 7 online edition of more than 100,000 consecutive diabetic-patient visits analyzed using the EyeArt AI Eye Screening System. The company says that the retrospective study reported that the system achieved greater than 91 percent sensitivity and specificity for detection of referable diabetic retinopathy. The authors, several of which are employees of Eyenuk, say the limitations of the study are its retrospective nature; the potential for misclassification by a single human grader and the lack of adjudicated multiple reader grading for each encounter, which is not possible in such a large study population; and that data on the mean age of the patients or the mean duration of diabetes are unavailable to assess the performance of the EyeArt system, stratified on these factors. Read more.
SOURCE: Eyenuk, August 2019
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