Subthreshold Nanosecond Laser Intervention in Age-Related Macular Degeneration The LEAD Randomized Controlled Clinical Trial
Robyn H Guymer, Zhichao Wu, Lauren AB Hodgson, Emily Caruso, Kate H Brassington, Nicole Tindill, Khin Zaw Aung, Myra B McGuinness, Erica L Fletcher, Fred K Chen, Usha Chakravarthy, Jennifer J Arnold, Wilson J Heriot, Shane R Durkin, Jia Jia Lek, Colin A Harper, Sanjeewa S Wickremasinghe, Sukhpal S Sandhu, Elizabeth K Baglin, Pyrawy Sharangan Show all
OPHTHALMOLOGY | ELSEVIER SCIENCE INC | Published : 2019
PURPOSE: There is an urgent need for a more effective intervention to slow or prevent progression of age-related macular degeneration (AMD) from its early stages to vision-threatening late complications. Subthreshold nanosecond laser (SNL) treatment has shown promise in preclinical studies and a pilot study in intermediate AMD (iAMD) as a potential treatment. We aimed to evaluate the safety of SNL treatment in iAMD and its efficacy for slowing progression to late AMD. DESIGN: The Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study is a 36-month, multicenter, randomized, sham-controlled trial. PARTICIPANTS: Two hundred ninety-two participants with bilateral lar..View full abstract
Awarded by National Health & Medical Research Council of Australia
Supported by the National Health & Medical Research Council of Australia (project grant no.: APP1027624 [R.H.G., C.D.L.]; and fellowship grant nos.: GNT1103013 [R.H.G.], APP1104985 [Z.W.], APP1054712 [F.K.C.], and APP1142962 [F.K.C.]); and Bupa Health Foundation, Australia (R.H.G., C.D.L.). The Centre for Eye Research Australia 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 2RT (R) 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 application and open-source platform OpenClinica allowed secure electronic data capture. The study is sponsored by the Centre for Eye Research Australia, an independent medical research institute and a not-for-profit company. The funders of this study had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. All authors had full access to all the data in the study and approved the final version and the corresponding author had the final responsibility for the decision to submit for publication.