NCT01790802

Laser Intervention in Early Age-Related Macular Degeneration Study

A Multi-centre, Randomized Trial Into the Safety and Efficacy of Nanosecond Microsurgical Laser Intervention in Early Age-related Macular Degeneration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Center for Eye Research Australia · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the progression to advanced age-related macular degeneration.

Detailed description

LEAD is a patient and assessor masked, multi-centre randomized controlled exploratory medical device clinical investigation of 240 participants (1:1 active to shame laser procedure) designed to assess the effectiveness of nanosecond laser treatment of patients with early high-risk AMD. No less than 240 participants will be randomized into either active laser treatment or sham laser procedure groups at a ratio of 1:1. Patient eligibility based on ocular inclusion criteria will be evaluated using measures of vision, fundus photography, OCT imaging, and macular integrity (MAIA) performed during the qualifying period. Fundus images and MAIA results will be sent to a coordinating centre where these will be reviewed to confirm eligibility based on lesion attributes and the criteria specified in the protocol. Following confirmation of eligibility by the coordinating centre, participants whom satisfy all the inclusion and exclusion criteria can be randomized. Allocation to treatment group will be stratified by smoking status. All participants will receive either active laser treatment or sham laser procedure at the treatment visit and be assessed for retreatment on a semi-annual basis. All participants will be contacted by telephone at 1 week and present for clinical examination visits at 1, 6, 12, 18, 24, 30 and 36 months.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	2RT nanosecond laser	active laser therapy

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2013-02-13
• Last updated: 2025-04-15

Locations

1 site across 1 country: Australia