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NOT YET RECRUITING
NCT07607496
NA

MacuTherm Performance Study in Patients With iAMD

Sponsor: OD-OS MacuTherm GmbH

View on ClinicalTrials.gov

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

Interventions

DEVICE

photothermal therapy

Patients receive individualized photothermal therapy in the study eye

DEVICE

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