Patients and methods
MAY, RETINA, DEL
This is a phase 2, prospective, double-blinded, randomized clinical trial conducted from May 2017 to November 2022 at two sites in Querétaro, México (Instituto Mexicano de Oftalmología and Instituto de la Retina del Bajío) and sponsored by the Consejo Nacional de Humanidades, Ciencias y Tecnologías (CONAHCYT, grants 247164, 289568, and A1-S-9620B) and the Universidad Nacional Autónoma de México (UNAM, grant 405PC). The study adhered to the guidelines of the Declaration of Helsinki, and the protocol and consent forms were approved by the Bioethics Committees of the Instituto de Neurobiología, UNAM and the Instituto Mexicano de Oftalmología. Each subject provided written informed consent and the study was supervised by an independent data and safety monitoring committee. The study was registered at 