Individualized Navigated Photothermal Therapy in Patients With Intermediate AMD: A Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Performance of theTherapy Proposed by Macula Explorer Using Navilas Laser System
The goal of this study is to demonstrate that photothermal therapy with the individually dosed treatment plan proposed by Macula Explorer delivered safely by Navilas® Laser System effectively improves the life of photoreceptors and reduces the progression of intermediate Age-related Macular Degeneration (iAMD) and preserves photoreceptors shown by Ellipsoid Zone Integrity (EZI). Participants will be randomized to either Treatment or Control Group. There will be 12 visits, monthly for the first 3 months, then quarterly until the end of the study after 2 years.
• Male, female, or diverse
• Age of 60 to 90 years old
• Clinically confirmed intermediate AMD (iAMD, AREDS category 3) with the presence of:
‣ At least 3 large drusen (diameter \> 125 μm) within the inner ring of 3mm diameter of the ETDRS Grid centered on the fovea (with or without reticular pseudodrusen (RPE))
⁃ combined with at least 1 of the following other signs:
• Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and/or
∙ Hyperreflective foci (HRF) adjacent to drusen (within 3 mm)
• Best corrected visual acuity between 65 and 87 letters
• Clear optic media
• Ability to communicate clearly and to understand and comply with the nature and requirements of the study
• Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines
• Willing to participate