EyeWorld Weekly Update, March 9, 2018

March 9, 2018
Volume 24 , Number 8

Primary endpoint achieved in Phase 3 trial for macular edema with noninfectious uveitis

The primary endpoint was met in a Phase 3 trial of suprachoroidal CLS-TA (Clearside Biomedical, Alpharetta, Georgia) for patients with macular edema associated with noninfectious uveitis, according to a company press release. Suprachoroidal CLS-TA is the company's proprietary suspension of triamcinolone acetonide for administration in the suprachoroidal space. The randomized, controlled, masked pivotal trial, called PEACHTREE, enrolled 160 patients. Ninety-six patients were randomized to the treatment arm and received two 4 mg doses of suprachoroidal CLS-TA 12 weeks apart. Sixty-four patients were randomized to have a sham procedure during the same 12-week time period. Patients were assessed every 4 weeks for up to 24 weeks. Ninety-seven percent of those enrolled (n=155) completed the full evaluation. At least 15 letters in best corrected visual acuity (BCVA) were gained by 47% of patients in the treatment arm as measured by the Early Treatment of Diabetic Retinopathy Study scale compared with 16% of patients having a sham procedure. This was the trial's primary endpoint and was statistically significant (P<0.001). The mean change from baseline BCVA was better in the treatment arm than the sham arm.

First patient enrolled in Phase 3 TOPAZ trial to treat macular edema associated with RVO

The first patient has been enrolled in a Phase 3 clinical trial called TOPAZ for suprachoroidal CLS-TA (Clearside Biomedical) used with an intravitreally administered anti-vascular endothelial growth factor (anti-VEGF) agent to treat macular edema with retinal vein occlusion (RVO), according to a company press release. TOPAZ is focused on the safety and efficacy of suprachoroidal CLS-TA along with the anti-VEGF agents ranibizumab (Lucentis, Genentech, South San Francisco) or bevacizumab (Avastin, Genentech) in treatment-naïve patients with RVO. TOPAZ is a multicenter, randomized, masked, controlled trial. In the trial's combination arm, patients will receive suprachoroidal CLS-TA with an intravitreal anti-VEGF agent at the commencement of the trial, an intravitreal anti-VEGF alone at week 4, and suprachoroidal CLS-TA along with an intravitreal anti-VEGF agent at weeks 12 and 24. The control arm will receive an intravitreal anti-VEGF agent alone at the start of the trial and every 4 weeks thereafter through week 24. The main objective of the trial will be to determine the proportion of patients in each arm with a BCVA improvement of at least 15 letters from baseline to 8 weeks after initial treatment. The company expects to enroll about 460 patients.

Ocular findings could help predict future memory loss

Eyes with moderate or severe retinopathy at age 60 may indicate who is more likely to develop thinking and memory problems by age 80 compared to people with healthy eyes, according to Jennifer Deal, PhD, and co-researchers. Their study included 12,317 people who took memory and thinking skills tests at the commencement of the study, 6 years later, then a third time about 20 years after the initial test. Retinal imaging was performed about 3 years after the study started. There were 11,692 people with no signs of retinopathy, 365 people with mild retinopathy, and 256 people with moderate to severe damage. Those with moderate to severe retinopathy were more likely to have larger drops in their memory and thinking test scores over time than those with healthy eyes. Test scores went down by 1.22 standard deviation units over 20 years compared with a decline of 0.91 in standard deviation units in health eyes. The study is published in Neurology.

Bascom Palmer receives $12 million gift to establish research center

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, has received a $12 million donation to establish a research center for macular degeneration and retinal diseases and to create a clinical research endowment. The gift was made by philanthropist Lois Pope, whose mother went blind from macular degeneration. The gift is the largest single donation received by Bascom Palmer, according to a school press release. The school will establish the Lois Pope Center for Retinal & Macular Degeneration Research on its Palm Beach Gardens campus.


  • Infectious keratitis from Stenotrophomonas maltophilia is a treatment challenge because of its resistance to aminoglycosides and cephalosporins, reported Sotiria Palioura, MD, and co-researchers. Their study focused on this uncommon cause of infectious keratitis. They conducted a retrospective review of records from 1987 to 2016 and identified 26 eyes from 26 patients treated at Bascom Palmer Eye Institute for an S. maltophilia cornea ulcer. Twelve patients were using corticosteroids at presentation. Eight patients had a history of penetrating keratoplasty (PKP), and nine wore contact lenses. All patients received topical antibiotics, two required therapeutic PKP, and one eye was enucleated. About 96% of isolates were susceptible to fluoroquinolones and 77.3% of them to polymyxin B/trimethoprim. Only 33.3% of tested isolates were susceptible to aminoglycosides and 58% to cephalosporins. In cases of S. maltophilia infection, fluoroquinolones and polymyxin B/trimethoprim should be used, the authors concluded. The research appears in Cornea.
  • In patients with glaucoma who are having cataract surgery with trabecular microbypass stent insertion, intravitreal steroid injections of a steroid and antibiotics may be a safe option, reported Trevor Kindle, MD, and coauthors. The 234 treatment eyes in this retrospective case series had an intravitreal injection of triamcinolone/moxifloxacin/vancomycin at the time of cataract surgery along with trabecular microbypass stent insertion. The 249 control eyes had the same procedure but received postoperative topical antibiotics, steroids, and nonsteroidal anti-inflammatory drugs. The mean reduction in glaucoma medication use was 0.24 drops in the study group compared with 0.80 drops in the control group; the mean IOP reduction was 2.59 mm Hg in the study group and 3.63 mm Hg in the control group. In 5.7% of patients in the study group, pressure spikes were detected versus in 3.7% of the control group. Both groups had similar postop IOP reductions and IOP spikes, leading researchers to conclude that the intravitreal injection option might be a safe choice. The research appears in the Journal of Cataract & Refractive Surgery.
  • A significant IOP decrease was measured at 3-6 months postoperatively in obese individuals having sleeve gastrectomy, according to Zvia Burgansky-Eliash and co-researchers. Their study included 32 patients who had a laparoscopic gastrectomy procedure. The mean body mass index decreased after surgery from 42 to 31, and the mean IOP decreased from 16.9 mm Hg to 14.1 mm Hg (P<0.001). The extent of IOP reduction was correlated with the baseline IOP and central corneal thickness. Major weight loss could benefit IOP in obese individuals with ocular hypertension, the authors concluded. The study appears in Acta Ophthalmologica.
  • The use of wide-area mosaic images provides reference values for mosaic corneal nerve fiber length (mCNFL) and apical whorl corneal nerve fiber length (wCNFL) and reveal a progressive degeneration of the subbasal nerve plexus as type 2 diabetes progresses in patients, reported Neil Lagali, MD, and co-researchers. They analyzed 163 mosaics from the eyes of 82 subjects with the use of laser scanning in vivo confocal microscopy. Patients were about the same age; 43 did not have type 2 diabetes, and 39 had the disease. The mCNFL and wCNFL were quantified and related to the presence and duration of diabetes (short duration <10 years and long duration >10 years). A lower mCNFL was associated with diabetes (P=0.032) and increased hemoglobin A1c (HbA1c) levels (P=0.047). The wCNFL was unaffected by diabetes or HbA1c (P>0.05). "Global subbasal nerve plexus patterns revealed marked degeneration of secondary nerve fiber branches outside the whorl region in long-duration diabetes," the researchers reported. The study appears in Investigative Ophthalmology & Visual Science.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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