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The study will evaluate the safety and tolerability of the R:GEN laser in patients with early-stage age-related macular degeneration.
Lutronic Vision has treated the first early-stage age-related macular degeneration (AMD) patient in its clinical trial evaluating the R:GEN laser.
Jhung Won Vojir, PhD, president and COO of Lutronic Vision, noted that the study kicked off following a delay related to the COVID-19 pandemic.
“We intend to use data from previous trials, this current trial and from future clinical evaluations to support the potential approval of R:GEN by the FDA,” he said in a statement.
The single-arm, open-label pilot study will enroll approximately 30 early-stage AMD patients who will be treated with R:GEN and evaluated at 24 and 48 weeks. The primary and secondary objectives are to assess the safety and tolerability of R:GEN in subjects with early stages of AMD; and to evaluate the progression and severity of AMD after treatment with R:GEN at 24 and 48 weeks post-treatment, respectively.
The company said it expects to complete the trial by the end of 2022, with results available in 2023.
“As AMD is a leading cause of blindness that results in permanent loss of central vision, R:GENT has the potential to address a significant unmet need by slowing or preventing disease progression,” Mark Humayun, MD, PhD, an ophthalmologist, engineer, scientist, inventor and recipient of the National Medal of Technology and Innovation from President Barack Obama, said in a statement.
The trial will be conducted at the Centre for Eye Research Australia in Melbourne, Australia, and will be led by Professor Robyn Guymer, who will be the study's principal investigator.