Boisbriand

Researchers are evaluating the Hexiris Microinvasive Scleral Trephine (MIST) system for treating Primary Open-Angle Glaucoma (POAG) in adults aged 40 years and older whose condition is not well controlled by topical drug therapies. This multicenter, open-label, non-randomized, single-arm study aims to reduce intraocular pressure (IOP) in the affected eye by creating a channel in the sclera. The study includes an initial safety phase with the first five patients treated in an operating room, followed by treatment of 20 patients in an outpatient clinic using a slit lamp in an aseptic environment. The treatment involves using the Hexiris MIST device, which includes a sclerectomy punch and injector assembly designed to remove a core of tissue to help lower IOP. Along with the device, patients receive a subconjunctival injection of mitomycin C at a concentration of 0.02-0.04% using sterile technique. The procedure is performed ab externo under topical anesthesia at the slit lamp. Postoperative care includes topical antibiotics and steroids. Participants will have follow-up visits the day after treatment, then at 1 week, and at 1, 2, 3, 6, 9, and 12 months afterward. During these visits, ophthalmologists will examine the treated eye and measure intraocular pressure. The primary outcome measured is the change in intraocular pressure from baseline to 6 months after treatment. The total follow-up period lasts for 12 months to monitor safety and performance of the device.

Researchers are evaluating the safety and effectiveness of ONL1204, a new eye treatment, in patients aged 55 and older who have geographic atrophy (GA) linked to age-related macular degeneration (AMD). GA associated with AMD is a leading cause of vision loss and blindness worldwide, often related to aging, lifestyle factors, and genetics. ONL1204 is an investigational drug designed to protect retinal cells by blocking a pathway that leads to cell death, which has shown promise in preclinical models. The study compares three groups receiving treatments via injections into the eye: two different doses of ONL1204 given at two different frequencies, Avacincaptad Pegol injections, and sham (placebo) injections. These treatments are administered intravitreally, meaning directly into the eye. The trial is conducted in multiple centers and is randomized and double-masked, meaning neither participants nor researchers know who receives which treatment. The study period lasts 48 weeks from enrollment to the end of treatment. Participants will attend regular visits throughout the 48 weeks to receive injections and undergo eye exams including assessments of visual acuity, eye pressure, and imaging of the retina to monitor the size and progression of GA lesions. Researchers will also evaluate safety and any side effects. The primary goal is to measure the effectiveness of the treatments over the full treatment period. Participants must continue or avoid certain eye nutritional supplements as agreed during the study. Safety monitoring and assessments will continue for the entire study duration.