From the editors of Review of Ophthalmology:
MAY IS HEALTHY VISION MONTH
In this issue: (click heading to view article)
Long-term Retinal Layer Changes in Patients Undergoing Intravitreal Ranibizumab for nAMD
Researchers analyzed long-term changes in retinal layers after intravitreal injections of ranibizumab in individuals with neovascular age-related macular degeneration.
The subjects were treated with 0.5-mg IVRs based on an as-needed protocol after the first three monthly doses over a 12-month follow-up period. Individuals underwent optical coherence tomography and best-corrected visual acuity evaluation at each visit. The ETDRS grid with central subfield (R1) (r 0.5 mm) and the inner ring (R2) (r 0.5 mm to 1.5 mm) was used for calculation of the mean thickness of each RL. Changes in the thickness of segmented RLs within the R1 and R2 of ETDRS circles at months three, six and 12 were compared to baseline.
The mean age was 72 ±7.4 years. The mean number of injections was 9.08 (range: 6 to 11). Here were some of the findings:
• Mean BCVA improved from 49.7 ±22.1 to 60.1 ±19.8 letters.
• Central macular thickness decreased from 390.25 ±149.6 to 312.74 ±118.4 μm.
• Thicknesses of GCL (from 23.93 ±13.73 to 19.50 ±9.50 μm in R1; p=
0.001, and from 44.5 ±12.6 to 39.6 ±10.6 μm in R2; p=
0.005); IPL (from 28.90 ±14.36 to 22.35 ±6.23 μm in R1; p=
0.001, and from 39.34 ±8.53 to 35.58 ±7.93 μm in R2; p=
0.004); and total inner RL (ILM to ELM) (from 222.93 ±93.09 to 180 ±53 μm in R1; p=
0.001, and from 255.06 ±42.74 to 240.25 ±40.37 μm in R2; p=
0.003) in the central and parafoveal rings decreased by a statistically significant amount at month-12.
• Decrease in INL was limited to month six (from 34.80 ±15.33 to 27.60 ±12.59 μm in R1; p=
0.001), while decreases in total outer RLs (ELM to RPE) (from 128.32 ±26.92 to 115.54 ±43.98 μm in R1; p=
0.001, and 103.81 ±16.73 to 96.38 ±16.22 μm in R2; p=
0.014) and RPE (from 39.12 ±22.33 to 29.70 ±22.05 μm in R1; p=
0.001, and from 31.27 ±13.11 to 24.40 ±9.99 μm in R2; p=
0.001) were limited to month three.
Researchers determined that significant changes were observed in the thickness of the inner RLs after one year of treatment with IVRs for nAMD. They added that a significant decrease in RPE thickness confined to the first months disappeared at month 12.
SOURCE: Inan, UU Baysal Z, Inan S. Long-term changes in retinal layers in patients undergoing intravitreal ranibizumab for neovascular age-related macular degeneration. Int Ophthalmol 2019; May 8. [Epub ahead of print].
Effect of Unilateral Endothelial Keratoplasty on Vision-Related QOL Outcomes in DETECT
In the primary Descemet Endothelial Thickness Comparison Trial, Descemet’s membrane endothelial keratoplasty had superior postoperative visual acuity compared with ultrathin Descemet’s stripping automated endothelial keratoplasty. Investigators aimed to determine the effect of DMEK and UT-DSAEK on vision-related quality of life.
A prespecified, secondary analysis of a two-surgeon patient- and outcome-masked randomized clinical trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction. The second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery, for evaluation of 38 eyes at baseline and three months, and 26 eyes at 12 months. Mean baseline visual acuity was 0.35 ±0.31 logMAR in the DMEK arm and 0.28 ±0.22 logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs’ dystrophy and one participant with pseudophakic bullous keratopathy.
Study eyes were randomized to receive either UT-DSAEK or DMEK. Responses to the National Eye Institute Visual Function Questionnaire-39 administered at baseline, and three and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis.
More women participated in both arms of the study (UT-DSAEK: 12 [63 percent]; DMEK: 11 [58 percent]); mean age was 68 ±11 years in the UT-DSAEK arm and 68 ±4 years in the DMEK arm. Here were some of the findings:
• Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at three months compared with baseline (n=38; CI, 4.9 to 13.3; p<0.001), and an 11.6-point improvement at 12 months compared with baseline (n=26; CI, 6.8 to 16.4; p<0.001).
• Eyes randomized to DMEK had 0.9 points more improvement in NEI VFQ-39 composite score at three months compared with UT-DSAEK after controlling for baseline NEI VFQ-39 (-6.2 to 8.0; p=0.80).
Investigators found that improvement in vision-related quality of life wasn’t shown to be greater with DMEK than with UT-DSAEK.
SOURCE: Ang MJ, Chamberlain W, Lin CC, et al. Effect of unilateral endothelial keratoplasty on vision-related quality-of-life outcomes in the Descemet Endothelial Thickness Comparison Trial (DETECT): A secondary analysis of a randomized clinical trial. JAMA Ophthalmol 2019; May 2. [Epub ahead of print].
Evaluation of Deep Convolutional Neural Networks for Glaucoma Detection
Scientists analyzed the performance of deep convolutional neural networks for glaucoma discrimination using color fundus images, as part of a retrospective study.
To investigate the discriminative ability of three DCNNs, they used a total of 3,312 images consisting of 369 images from glaucoma-confirmed eyes, 256 images from glaucoma-suspect eyes diagnosed by a glaucoma expert and 2,687 images judged to be nonglaucomatous eyes by a glaucoma specialist. They also investigated the effects of image size on the discriminative ability and heatmap analysis to determine which parts of the image contributed to the discrimination. Additionally, they used 465 poor-quality images to investigate the effect of poor image quality on discriminative ability. Here were some of the findings:
• Three DCNNs showed areas under the curve of 0.9 or more.
• The AUC of the DCNN using glaucoma-confirmed eyes against nonglaucomatous eyes was higher than that using glaucoma-suspected eyes against nonglaucomatous eyes by approximately 0.1.
• The image size didn’t affect the discriminative ability.
• Heatmap analysis showed that the optic disc area was the most important area for the discrimination of glaucoma.
• The image quality affected the discriminative ability, and the inclusion of poor-quality images in the analysis reduced the AUC by 0.1 to 0.2.
Scientists reported that DCNNs might be a useful tool for detecting glaucoma or glaucoma-suspected eyes via fundus color images. They suggested that proper preprocessing and collection of qualified images were essential to improving the discriminative ability.
SOURCE: Phan S, Satoh S, Yoda Y, et al. Evaluation of deep convolutional neural networks for glaucoma detection. Jpn J Ophthalmol 2019;63:3:276-83.
Using OCTA to Monitor Neovascular Regression on Fibrovascular Membrane After Preoperative Intravitreal Conbercept Injection
Researchers quantified the preoperative neovascular change pattern on the fibrovascular membrane in proliferative diabetic retinopathy within seven days after intravitreal injection of conbercept using optical coherence tomography angiography.
In the prospective, observational study of PDR patients with visible FVM receiving or not receiving IVC, researchers assessed neovascular changes by OCTA pre-IVC and one, three, five and seven days post-IVC. They quantified vessel skeleton density and vessel density (VD) by an intensity-based optical microangiography algorithm. They calculated the interclass correlation coefficient to assess the agreement between measurements, and compared the SD and VD between follow-ups using repeated-measures analysis in the IVC group. Here were some of the findings:
• The ICC was 0.992 (CI, 0.982 to 0.996) for vessel skeleton density, and 0.926 (CI, 0.838 to 0.912) for VD of neovascularization.
• The neovascularization on FVM significantly regressed in the IVC group (n=16) compared with no IVC (n=8) (p=0.001 for vessel skeleton density and p<0.001 for VD).
• The comparisons between consecutive follow-ups showed a statistically significant reduction in vessel skeleton density and VD at one and three days post-IVC; however, from day three onward, the vessel skeleton density and VD remained unchanged.
• No development or progression of tractional retinal detachment was found within the seven-day period after IVC.
Researchers wrote that OCTA-based quantification of the neovascularization on FVM in PDR was feasible, with high inter-reader agreement. They added that regression of neovascularization reached a plateau three days after IVC.
Source: Hu Z, Su Y, Xie P, et al. OCT angiography-based monitoring of neovascular regression on fibrovascular membrane after preoperative intravitreal conbercept injection. Graefes Arch Clin Exp Ophthalmol 2019; May 3. [Epub ahead of print].
Takeda Agrees to Sell Xiidra to Novartis, Collaborates with Skyhawk
Takeda Pharmaceutical Company entered into agreements to divest its Xiidra (lifitegrast ophthalmic solution) 5% product to Novartis and its TachoSil Fibrin Sealant Patch to Ethicon to focus on business areas core to its long-term growth and facilitate rapid reduction of its debt following its acquisition of Shire. Takeda will receive $3.4 billion upfront in cash and up to an additional $1.9 billion in potential milestone payments from Novartis, and approximately $400 million upfront in cash from Ethicon. Read more.
In addition, Skyhawk Therapeutics announced a strategic collaboration with Takeda in which Skyhawk will use its SkySTAR technology platform to discover and pre-clinically develop small-molecule treatments directed to certain neurological disease targets. Read more.
GenSight Announces Positive Data Safety Monitoring Board Review and Continuation of PIONEER Phase I/II Clinical Trial
GenSight Biologics announced that the independent Data Safety Monitoring Board completed its first safety review of the ongoing PIONEER Phase I/II clinical trial of GS030 combining gene therapy and optogenetics for the treatment of retinitis pigmentosa. The DSMB confirmed the absence of any safety issues for the first cohort of three subjects who received a single intravitreal injection of 5e10 vg combined with a wearable optronic visual stimulation device. The DSMB recommended moving forward as planned without any modification in the protocol and recruiting the second cohort of three subjects receiving an escalating dose of 1.5e11 vg. Read more.
Watchful Waiting Reasonable for Patients with DME and Good Vision
People with good vision, despite having center-involved diabetic macular edema, can safely forgo immediate treatment of their eye condition as long as they are closely monitored and treatment begins promptly if vision worsens, according to clinical trial results in JAMA Ophthalmology. The study was conducted by the DRCR Retina Network. Read more.
2Ctech Initiates First Clinical Program Using Nanoparticles to Treat RP
2Ctech initiated a clinical program to demonstrate the effectiveness and safety of Quantum Dots to achieve photovoltaic stimulation of the neural retina for preservation or enhancement of vision in patients with retinal degenerative diseases, in particular retinitis pigmentosa. In previous pre-clinical and first-in-human trials, a one-time injection of QDs was administered into the vitreous and trial outcomes provided strong evidence of safety and positive indications of meaningful vision enhancement, the company claims. Read more.
Genentech Presents Phase III Data for Neuromyelitis Optica Spectrum Disorder (Devic’s Disease)
Genentech presented new Phase III data on neuromyelitis optica spectrum disorder also known as Devic’s disease, for which there are no approved treatments. Genentech says the SAkuraSky data presented showed Genentech’s investigational medicine satralizumab demonstrated efficacy across a broad NMOSD patient population compared with placebo, as an add-on to baseline immunosuppressants and/or corticosteroids. Read more.
Higher Cholesterol Linked to Increased Glaucoma Risk, But Statins Seem to Help
Risk for primary open-angle glaucoma seems to increase as cholesterol levels increase, but long-term statin use may be protective, according to an observational study in JAMA Ophthalmology. Nearly 140,000 U.S. individuals aged 40 or older without glaucoma at baseline were followed for 15 or more years. During that time, 0.6 percent developed POAG. Overall, higher total serum cholesterol level was associated with increased glaucoma risk. In particular, for each 20-mg/dL increase in total cholesterol, glaucoma risk increased by 7 percent. Meanwhile, statin use for five years or longer was associated with a 21-percent reduction in risk, even after adjustment for total cholesterol level. The authors noted that statins might lower intraocular pressure and have neuroprotective effects on retinal ganglion cells. Read more.
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