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MacuTherm Performance Study in Patients With iAMD
Sponsor: OD-OS MacuTherm GmbH
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.
Official title: 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
Key Details
Gender
All
Age Range
60 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-05
Completion Date
2028-12
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
photothermal therapy
Patients receive individualized photothermal therapy in the study eye
Sham treatment
Patients receive sham treatment in the study eye
Locations (4)
Department of Ophthalmology at Hannover Medical School
Hanover, Germany
Department of Ophthalmology, University Medical Center Schleswig-Holstein
Lübeck, Germany
Potsdam Eye Clinic at Gräfehaus
Potsdam, Germany
AugenNord Medical Practice and Surgical Center
Schleswig, Germany