From the editors of Review of Ophthalmology:
DECEMBER IS SAFE TOYS AND CELEBRATIONS MONTH
In this issue: (click heading to view article)
Ranibizumab Treatment in Treatment-naive nAMD
Researchers evaluated the effectiveness, safety and treatment patterns of ranibizumab 0.5 mg in treatment-naive patients with neovascular age-related macular degeneration enrolled in the LUMINOUS study, billed as a “global real-world study.”
The five-year, prospective, multicenter, observational study recruited 30,138 adult patients (treatment-naïve, or previously treated with ranibizumab or other ocular treatments) who were treated according to the local ranibizumab label.
A total of 6,241 treatment-naive neovascular age-related macular degeneration patients were included. At baseline, mean age was 75 ±10.2 years, 54.9 percent were females and 66.5 percent were Caucasian. Here are some of the findings:
• Baseline visual acuity was 51.9 letters (Snellen: 20/92). The mean visual acuity gain at one year was 3.1 ±16.51 letters (n=3,379) with a mean of 5 ±2.7 injections and 8.8 ±3.3 monitoring visits.
• The mean visual gains presented by injection frequencies were:
o <3 injections (n=537), 1.6 ±14.93 letters;
o three to six injections (n=1,924), 3.3 ±16.57 letters; and
o >6 injections (n=918), 3.7 ±17.21 letters.
• Stratified by baseline visual acuity, the mean visual acuity change was:
o baseline visual acuity <23 (n=382), 12.6 ±20.63 letters;
o baseline visual acuity 23 to <39 (n=559), 6.7 ±17.88 letters;
o baseline visual acuity 39 to <60 (n=929), 3.6 ±16.41 letters;
o baseline visual acuity 60 to <74 (n=994), 0.3 ±13.83 letters; and
o baseline visual acuity ≥74 (n=515), -3 ±11.82 letters.
• Incidence of adverse events was: ocular, 8.2 percent; nonocular, 12.8 percent.
• Incidence of serious adverse events was: ocular, 0.9 percent; nonocular, 7.4 percent.
Researchers wrote that the results demonstrated the effectiveness and safety of ranibizumab in treatment-naive nAMD patients.
Source: Holz FG, Figueroa MS, Bandello F, et al. Ranibizumab treatment in treatment-naive neovascular age-related macular degeneration: Results from LUMINOUS, a global real-world study. Retina 2019; Nov 19. [Epub ahead of print].
Intraoperative Iodine in Cataract Surgery
Investigators evaluated whether preoperative topical antibiotics were essential for infection control as long as iodine disinfection was performed during surgery, as part of a crossover equivalence trial. In 204 eyes of 102 individuals who underwent routine bilateral cataract surgery, one eye was treated with intraoperative iodine, the other with preoperative topical antibiotics.
For the intraoperative iodine eyes, 5 mL of 0.25% povidone-iodine was applied at two stages: (1) just after the placement of the speculum and (2) before intraocular lens insertion. For the contralateral eyes, preoperative topical antibiotics were administered three days before surgery without intraoperative iodine. Conjunctival culture samples were obtained at three time points: pre-surgery; beginning of surgery; and post-surgery. Real-time polymerase chain reaction samples were obtained at the beginning of surgery and before IOL insertion. Intracameral moxifloxacin was applied in all the cases. Here are some of the findings:
• Pre-surgery positive bacterial culture rates were: for intraoperative iodine eyes, 95.1 percent; and for preoperative topical antibiotics eyes, 98 percent.
• The beginning of surgery positive bacterial culture rates were: for intraoperative iodine eyes, 7.8 percent; and for preoperative topical antibiotics eyes, 5.9 percent.
• The post-surgery positive bacterial culture rates were: for intraoperative iodine eyes, 60.8 percent; and for preoperative topical antibiotics eyes, 62.7 percent.
• No significant differences in positive bacterial culture rates were found at any time points.
• In intraoperative iodine eyes, the bacterial DNA copy number at the beginning of the surgery time point was significantly lower than that for the preoperative topical antibiotics eyes.
Investigators determined that the cleanliness of the operative field without using topical antibiotics was equivalent to that of the conventional method (i.e., preoperative antibiotics without intraoperative iodine) when intraoperative iodine was used.
SOURCE: Matsuura K, Miyazaki D, Sasaki SI, et al. Effectiveness of intraoperative iodine in cataract surgery: Cleanliness of the surgical field without preoperative topical antibiotics. Jpn J Ophthalmol 2019; Nov 27. [Epub ahead of print].
Outcomes in DME Patients Requiring Cataract Surgery in VISTA & VIVID
Scientists evaluated the impact of cataract surgery on visual and anatomic outcomes in individuals with diabetic macular edema treated with intravitreal aflibercept injection or laser control who didn’t require rescue therapy, as part of a post hoc analysis of Phase III trials VISTA and VIVID.
Participants included 54 individuals (laser, n=11; IAI, n=43) who underwent cataract surgery during the study period.
In VISTA and VIVID, subjects received IAI 2 mg q4 weeks (2q4), IAI 2 mg q8 weeks following five monthly doses (2q8) or laser control through week 100. Starting at week 24, if rescue treatment criteria were met, IAI subjects received lasers; laser patients received IAI 2q8 (following five monthly doses). Individuals who received rescue treatment before cataract surgery were excluded.
Main outcome measures included best-corrected visual acuity and central retinal thickness in the laser control and pooled IAI groups, before and after cataract surgery. Here are some of the findings:
• The cumulative incidence of cataract surgery didn’t depend on treatment group assignment (rate ratio: CI, 1.517 [0.782, 2.944]; p=
• At the last study visit before surgery: BCVA was 62.2 letters, and CRT was 342 μm in the laser control; and BCVA was 56.9 letters, and CRT was 301 μm in the IAI group.
• At the first study visit post-cataract surgery, BCVA was significantly improved in the laser control group to 73.5 letters (p=
0.010 compared with last visit before surgery); and in the IAI group to 67.2 letters (p<
0.001 compared with last visit before surgery).
• At the first study visit post-cataract surgery, CRT change was: in the laser control group, a modest increase to 364 μm (p>
0.05 compared with the last visit before surgery); in the IAI group, a modest increase of 359 μm (p=
0.013 compared with the last visit before surgery).
Scientists found that the incidence of cataract surgery was similar in the IAI and laser control groups. They determined that, despite a modest worsening in CRT after cataract surgery, BCVA improved in both treatment groups.
SOURCE: Moshfeghi AA, Thompson D, Berliner AJ, et al. Outcomes in patients with diabetic macular edema requiring cataract surgery in VISTA and VIVID studies. Ophthalmology Retina 2019; Nov 4. [Epub ahead of print].
CCT in Corneal Edema Using Ultrasound Pachymetry, Scheimpflug Camera and AS-OCT
Researchers analyzed the influence of different degrees of corneal edema on the reliability and reproducibility of central corneal thickness measurements made by a Scheimpflug camera (Pentacam), anterior segment optical coherence tomography and ultrasound pachymetry.
Forty-four individuals undergoing ophthalmic surgery were included in the prospective study. Two researchers acquired all measurements and performed Pentacam and AS-OCT measurements in randomized order, followed by USP. Each investigator took two measurements with each device. They took apex values from the Pentacam and corneal apex cut in the AS-OCT, and averaged two cycles of four measurements with USP to calculate CCT. They determined coefficients of variation (COV) and intraclass correlation coefficients (ICC). To investigate the reproducibility in different degrees of corneal edema, researchers subdivided subjects into edema more/less than 10 percent of CCT, ≥/<600 μm and >650 μm CCT. Here are some of the findings:
• No significant differences were recorded for each investigator and measuring device.
• Overall, the devices differed significantly in the <600 μm group (ANOVA p<
• The reproducibility decreased with greater degrees of corneal edema (in particular for investigator one) and USP measurements.
• No significant overestimation of corneal thickness by the Pentacam was recorded in greater degrees of corneal edema.
Researchers concluded that USP measurements were highly user-dependent, especially with greater degrees of corneal edema. Nevertheless, they reported, all methods reached a high level of agreement for CCT measurements in greater degrees of corneal edema. The researchers noted that lesser degrees of corneal edema revealed the only significant differences between the three devices.
SOURCE: David K, Mandana HZ, Niklas P, et al. Reproducibility and reliability of central corneal thickness determination in more and less profound corneal edema using ultrasound pachymetry, a Scheimpflug camera and anterior segment OCT. Graefes Arch Clin Exp Ophthalmol 2019; Nov 21. [Epub ahead of print].
Positive Phase III Results Reported for Genentech’s Satralizumab
Genentech announced that data from SAkuraSky, a Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD) reveal that only eight of 41 patients (20 percent) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse, compared with 18 of 42 patients (43 percent) treated with placebo in combination with baseline therapy (HR=0.38, CI: 0.16 to 0.88; p=0.02). Findings included that 89 percent, 78 percent and 74 percent of patients on satralizumab in combination with baseline therapy were relapse-free at weeks 48, 96 and 144 compared with 66 percent, 59 percent and 49 percent on placebo in combination with baseline therapy. The findings were published in the Nov. 27 online issue of the New England Journal of Medicine. Read more.
Limelight Bio Emerges with $75 Million to Develop Gene Therapies
Limelight Bio, a privately held biopharmaceutical company developing novel gene therapies in ophthalmology and other medical specialties, raised $75 million in financing from Apple Tree Partners. Founded in 2017, Limelight Bio has developed proprietary technologies, advanced targets and drug candidates designed to overcome key limitations of gene therapy and gene editing in areas such as severe retinal diseases for which no current therapies exist. Read more.
Philanthropists Donate $1 Million to Launch Orbis Innovation Fund
On Giving Tuesday, Orbis International launched its Silicon Valley Orbis Innovation Fund, which seeks to raise $8 million in donations to ensure access to quality eye care and ophthalmological training. The Fund kicked off with a $1 million lead donation from Silicon Valley philanthropists Susan and John A. Sobrato. The money will be used to develop new technologies in telemedicine, artificial intelligence, simulation and virtual reality to increase access to training for eye-care teams in low- and middle-income settings. Orbis began using technology such as its Flying Eye Hospital in 1982 with the goal of ending avoidable blindness. Orbis has a presence in 18 countries and uses its Cybersight telemedicine platform to continue its outreach, it says. Read more.
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