Volume 20, Number 4Monday, January 20, 2020JANUARY IS GLAUCOMA AWARENESS MONTH In this issue: (click heading to view article)
Retinal Leakage Index Dynamics on Ultra-Widefield FA in Eyes Treated with Intravitreal Aflibercept for PDR: RECOVERY StudyResearchers aimed to characterize leakage indices on ultra-widefield fluorescein angiography in proliferative diabetic retinopathy treated with intravitreal aflibercept. The prospective study enrolled subjects for treatment of proliferative diabetic retinopathy randomized 1:1 to receive 2-mg intravitreal aflibercept every four weeks (2q4) or every 12 weeks (2q12).Researchers analyzed ultra-widefield fluorescein angiography images obtained at baseline, 24 and 48 weeks using a semiautomated leakage segmentation platform. They calculated panretinal and zonal leakage indices. Forty eyes of 40 subjects were included, and mean age was 48 ±12.1 years. Mean number of injections was 11 ±1.7 in the 2q4 arm and 4 ±0.4 in the 2q12 arm. Median baseline leakage index in the 2q4 was 5.1 percent, and median baseline leakage index in the 2q12 group was 4.3 percent (p=0.28). Here were some of the findings: • At 24 and 48 weeks, the 2q4 group significantly improved to 1.1 percent (-79 percent, p<0.0001). • At week 24, the 2q12 group demonstrated non-significant improvement (3.4 percent; -21 percent, p=0.47); by week 48, improvement was significant (1.4 percent; -68 percent, p=0.02). • The 2q4 group resulted in lower leakage index (1.1 percent) compared with the 2q12 group at 24 weeks (3.4 percent)(p=0.008), but by 48 weeks, leakage index was similar between both groups (1.1 percent [2q4 group] vs. 1.4 percent [2q12 group]; p=0.34). Researchers found that proliferative diabetic retinopathy treated with intravitreal aflibercept demonstrated significant leakage index reductions at one year. Monthly dosing provided more rapid reductions in leakage index compared with quarterly dosing. Source: Babiuch AS, Wykoff CC, Srivastava SK, et al. Retinal leakage index dynamics on ultra-widefield fluorescein angiography in eyes treated with intravitreal aflibercept for proliferative diabetic retinopathy in the RECOVERY study. Retina 2020; Jan 8. [Epub ahead of print]. Private Equity in U.S. Ophthalmology & Optometry: Acquisitions from 2012 to 2019Investigators identified temporal and geographic trends in 228 private equity-backed acquisitions of ophthalmology and optometry practices in the United States, as part of a cross-sectional study using private equity acquisition and investment data from Jan. 1, 2012, to Oct. 20, 2019. SOURCE: Chen EM, Cox JT, Begaj T, et al. Private equity in ophthalmology and optometry: Analysis of acquisitions from 2012 to 2019 in the United States. Ophthalmology 2020; Jan 10. [Epub ahead of print]. Efficacy of a T&E Regimen with Ranibizumab in nAMDScientists wrote that, although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) study provided data to show noninferiority of treat-and-extend (T&E) strategies at 12 months, few data exist on 24-month T&E trials compared with monthly dosing.Scientists compared the efficacy of ranibizumab using a T&E regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration after 24 months. The randomized, open-label, multicenter, noninferiority intent-to-treat trial with a margin of -5 letters in best-corrected visual acuity from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 individuals with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to Aug. 28, 2018, and the researchers analyzed data between Aug. 29 and Sep. 12, 2018. Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab 0.5 mg in either a T&E or monthly dosing regimen. Main outcomes and measures included mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24. Of the 580 randomized individuals, 350 were women (60.3 percent) and 547 were white (94.3 percent). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3 percent) had completed the study, and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over two years (CI, 5.4-6.5; p<.001). Here were some of the findings: • The mean BCVA improvement in the T&E arm (6.8 ±14.1) letters, was better than the monthly arm (6 ±12.6) letters (difference, 0.9; CI, -1.6 to 3.3; p=.21). • In the T&E group, 25.5 percent of the group had a gain of 15 or more letters vs. 23.1 percent of the monthly treatment group (difference, 2.4 percent; CI, -6.8 to 11.6 percent; p=.59). • In the T&E group, 6.5 percent had a loss of 15 or more letters vs. 5.8 percent of the monthly treatment group (difference, -0.7 percent; CI, -9.9 to 8.5 percent; p=0.85). Scientists wrote that a change in vision from baseline wasn’t worse with a T&E compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits. SOURCE: Kertes PJ, Galic IJ, Greve M, et al. Efficacy of a treat-and-extend regimen with ranibizumab in patients with neovascular age-related macular disease: A randomized clinical trial. JAMA Ophthalmol 2020; Jan 9. [Epub ahead of print]. Comparing Two Techniques for Graft Implantation in DMEKResearchers wrote that Descemet’s membrane endothelial keratoplasty has developed into a safe procedure for replacing diseased corneal endothelium. However, they added that DMEK still results in a significant donor endothelial cell loss. In this study, researchers compared two different graft implantation techniques.They retrospectively compared 20 individuals undergoing DMEK involving a DMEK injection cartridge to flush the graft into the anterior chamber (G-38635 single-use DMEK-Cartridge, Geuder AG; group A), with 20 individuals that had a standard lens injection cartridge (AT.Smart Cartridge, Carl Zeiss Meditec; group B) used to push the graft with a plunger. Outcome parameters were intraoperative orientation of the graft, insertion-to-attachment time, rebubbling rates and postoperative best spectacle-corrected visual acuity, endothelial cell count and central corneal thickness after 12 months. The surfaces of both cartridges were evaluated by scanning electron microscopy. Here were some of the findings: • In group A, the insertion-to-attachment time was significantly higher (p=0.003). • Initially, the graft was oriented correctly in 40 percent of individuals in group A compared with 90 percent in group B (p=0.001). • No differences were obtained between both groups regarding central corneal thickness, endothelial cell count or BSCVA, and rebubbling rates after 12 months. • Scanning electron microscopy analysis demonstrated a rougher and sharper cartridge surface in group B. Researchers concluded that significant differences between insertion techniques regarding correct graft orientation directly after graft implantation led to prolonged insertion-to-attachment time when the graft was flushed instead of pushed into the anterior chamber. SOURCE: Siebelmann S, Janetzko M, König P, et al. Flushing versus pushing technique for graft implantation in Descemet membrane endothelial keratoplasty. Cornea 2019; Dec 20. [Epub ahead of print]. BRIEFLY CustomFlex Artificial Iris Receives CMS Transitional Pass-through Payment Status Exonate & Janssen to Develop Retinal Vascular Disease Treatments MacuLogix Introduces AdaptDx Pro, Guided by “Theia” Improved Reimbursement for Endoscopic Cyclophotocoagulation When Combined with Cataract Surgery Oyster Point’s OC-01 Nasal Spray Advances in Phase II Review of Ophthalmology® Online is published by the Review Group, a Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073. |