Clinical Trial

MacuTherm Performance Study in Patients With iAMD

Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 4 -> 9 locations 2026-08-12
critical Recruitment opened 2026-06-05
Trial Details
NCT Number NCT07607496
Lead Sponsor OD-OS MacuTherm GmbH
Conditions Intermediate AMD
Enrollment 240 participants
Start Date 2026-05-29
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11