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MacuTherm Performance Study in Patients With iAMD

NCT07607496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Intermediate AMD

Interventions

DEVICE

photothermal therapy

Patients receive individualized photothermal therapy in the study eye

DEVICE

Sham treatment

Patients receive sham treatment in the study eye

Sponsors & Collaborators

  • OD-OS MacuTherm GmbH

    lead INDUSTRY

Principal Investigators

  • Jan Tode, Prof. Dr. med. · OD-OS MacuTherm GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607496 on ClinicalTrials.gov