Investigators presented updates on a number of closely watched clinical trials at the Retina Subspecialty Day on Friday. Here are highlights from 3 ongoing studies.
Yutiq
The trial. Phase 3 study of a 0.18-mg fluocinolone acetonide insert (Yutiq) versus sham in 129 affected patients with noninfectious posterior uveitis.
What’s known. Uveitis flares are much less common in Yutiq-treated patients than in controls at 6 and 12 months. EyePoint Pharmaceuticals received FDA approval for Yutiq .
Update. The therapeutic effect is maintained at 24 months. Patients treated with a single Yutiq insert continued to have less inflammation, less need for systemic or local rescue therapy, and better resolution of macular edema than controls. There were no unanticipated side effects; patients had higher rates of cataract extraction than controls, and the groups had similar rates of treatment for elevated IOP. The reason for this difference is not clear.
2RT Laser
The trial. Multicenter, randomized, masked study of subthreshold nanosecond laser treatment (2RT laser; Ellex) versus sham in 292 patients with bilateral large drusen (>125 µm).
What’s known. Preclinical and pilot studies suggest the laser may reverse signs of intermediate AMD without damaging the retina — but laser-treated patients progress just as quickly as controls to late AMD.
Update. Investigators found that the laser may benefit certain patients but not others. Post hoc analysis revealed that the laser’s efficacy depends on the clinical phenotype: Progression to late AMD occurred 4-fold slower in laser-treated eyes without reticular pseudodrusen (RPD) — but 2.5-fold faster in eyes with RPD.
Prima
The trial. Feasibility and safety trial of a miniature wireless photovoltaic subretinal implant (Prima) in patients with atrophic AMD.
What’s known. Five patients with atrophic dry AMD are currently wearing Pixium Vision’s bionic vision system. The implant appears to restore central visual perception, consistent with reports earlier this year.
Update. By now, all 5 patients have reached the trial’s goal: visual perception in the area of a former scotoma. The implant appears safe. Prima outperforms other prosthetics, offering visual acuity of 20/460 — only 15 percent below the theoretical limit for 100-mm pixels — and most patients can recognize complex patterns close to the implant’s theoretical maximum resolution. — Anni Griswold
Financial disclosures.
Yutiq — Quan Dong Nguyen, MD: AbbVie: C; Santen, Inc.: C
2RT Laser — Robyn H. Guymer, MBBS, PhD: None.
Prima — Jose A. Sahel, MD: None.
Disclosure key. C = Consultant/Advisor; E = Employee; L = Speakers bureau; O = Equity owner; P = Patents/Royalty; S = Grant support.
Next story from AAO 2018—Atropine Treatment for Myopia: Donald Tan, MD, FRCS, FRCOphth, presented an overview of research on atropine treatment for myopia and introduced his latest trial, ATOM3.