Subthreshold Nanosecond Laser in Age-Related Macular Degeneration: Observational Extension Study of the LEAD Clinical Trial
Robyn H Guymer, Fred K Chen, Lauren AB Hodgson, Emily Caruso, Colin A Harper, Sanjeewa S Wickremashinghe, Amy C Cohn, Pyrawy Sivarajah, Nicole Tindill, Chi D Luu, Zhichao Wu
OPHTHALMOLOGY RETINA | ELSEVIER INC | Published : 2021
PURPOSE: To evaluate the long-term effect of subthreshold nanosecond laser (SNL) treatment on progression to late age-related macular degeneration (AMD). DESIGN: Observational extension study of a randomized, sham-controlled trial. PARTICIPANTS: Two hundred twelve participants with bilateral large drusen. METHODS: The Laser Intervention in the Early Stages of AMD (LEAD) study was a 36-month trial where participants were randomized to receive SNL or sham treatment in 1 eye at 6-monthly intervals up to 30 months. After the completion of the LEAD study, the 2 largest recruiting sites offered remaining participants an opportunity to enroll in a 24-month observational extension study. This study ..View full abstract
Awarded by National Health & Medical Research Council of Australia
This study was supported by National Health & Medical Research Council of Australia (project grant no.: APP1027624 [RHG and CDL], and fellowship grant no.: GNT1103013 (RHG), APP1104985 [ZW], GNT1054712 [FKC], MRF1142962 [FKC] and GNT1128343 [SSW]). CERA receives operational infrastructure support from the Victorian Government. Ellex R&D Pty Ltd (Adelaide, Australia) provided partial funding of the central coordinating center and the in-kind provision of Ellex 2RTTM laser systems, ongoing support of those systems and the Macular Integrity Assessment microperimeters for the duration of the study. The web-based Research Electronic Data Capture (REDCap) application and open-source platform OpenClinica allowed secure electronic data capture. The study is sponsored by the Centre for Eye Research Australia (CERA), an independent medical research institute and a not-for-profit company.