483
Participants
Start Date
October 11, 2023
Primary Completion Date
May 31, 2029
Study Completion Date
May 31, 2029
N-acetylcysteine
After randomization, participants will be given about 10-months supply of study drug (intervention), with instructions to take 3 effervescent tablets in water twice a day. They will return to the clinic at M4.5 for evaluation and then at M9, M18, M27, M36, M40.5 and M45. At each in-clinic visit, drug reconciliation will occur. At each visit at Baseline, M9, M18, M27, M36, that is, every 9 months, participants will be given another 10-month supply of study drug.
Placebo
After randomization, participants will be given about 10-months supply of placebo, with instructions to take 3 effervescent tablets in water twice a day. They will return to the clinic at M4.5 for evaluation and then at M9, M18, M27, M36, M40.5 and M45. At each in-clinic visit, efficacy and safety assessments will be done and drug reconciliation will occur. At baseline, M9, M18, M27, and M36 participants will be given another 10-month supply of placebo.
Medical University of Graz, Department of Ophthalmology, Graz
Scheie Eye Institute, Philadelphia
Wilmer Eye Institute- Johns Hopkins University, Baltimore
Emory University, Emory Eye Center, Atlanta
University of Florida - Jacksonville, UF Health Jacksonville, Jacksonville
Vitreo Retinal Associates, Gainesville
University of Miami, Bascom Palmer Eye Institute, Miami
Vanderbilt University, Vanderbilt Eye Institute, Nashville
University of Michigan, Kellogg Eye Center, Ann Arbor
University of Iowa, Carver College of Medicine, Iowa City
Medical College of Wisconsin, The Eye Institute, Milwaukee
University of Wisconsin - Madison, McPherson Eye Research Institute, Madison
University of Minnesota, Department of Ophthalmology and Visual Neurosciences, Minneapolis
Mayo Clinic, Department of Ophthalmology, Rochester
Northwestern University, Evanston
University Of Illinois At Chicago, Chicago
University of Tübingen, Department für Augenheilkunde, Tübingen
University of Oklahoma, Dean McGee Eye Institute, Oklahoma City
Retina Foundation of the Southwest, Dallas
University of Utah, Moran Eye Center, Salt Lake City
University of Southern California, Keck School of Medicine, Los Angeles
University of California - San Francisco, Department of Ophthalmology, San Francisco
Stanford University, Byers Eye Institute, Stanford
University of California - Davis, Department of Ophthalmology & Vision Science, Davis
University of Washington, Department of Ophthalmology, Seattle
Harvard University, Mass. Eye and Ear, Boston
McGill University, The Research Institute of the McGill University Health Center, Montreal
Radboud University, Radboud University Medical Centre, Nijmegen
University of Amsterdam, Amsterdam Medical Center, Amsterdam
Universitätsspital Basel, Eye Clinic, Basel
University College London, Moorfields Eye Hospital, London
Collaborators (2)
National Eye Institute (NEI)
NIH
Duke University
OTHER
Emory University
OTHER
Massachusetts Eye and Ear Infirmary
OTHER
Mayo Clinic
OTHER
Medical College of Wisconsin
OTHER
Retina Foundation of the Southwest
OTHER
Stanford University
OTHER
University of California, Davis
OTHER
University of Florida
OTHER
University of Iowa
OTHER
University of Miami
OTHER
University of Michigan
OTHER
University of Minnesota
OTHER
University of Oklahoma
OTHER
University of Southern California
OTHER
University of Utah
OTHER
University of Washington
OTHER
University of Wisconsin, Madison
OTHER
Vanderbilt University
OTHER
Vitreo Retinal Associates, PA
UNKNOWN
University of Houston
OTHER
Medical University of Graz
OTHER
McGill University
OTHER
Universität Tübingen
OTHER
Radboud University Medical Center
OTHER
University of Amsterdam
OTHER
University Hospital, Basel, Switzerland
OTHER
University College London Hospitals
OTHER
Northwestern University
OTHER
University of Pennsylvania
OTHER
Johns Hopkins University
OTHER