MacuTherm Performance Study in Patients With iAMD

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.

Study Overview

• Status: Recruiting
• Conditions: Intermediate AMD
• Intervention / Treatment: Device: photothermal therapy; Device: Sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Tode, Prof. Dr. med.; Phone Number: +49 3328 31 282-100; Email: Jan.Tode@od-os.com

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Not yet recruiting
    • Department of Ophthalmology at Hannover Medical School
    • Contact: Maximilian LJ Hamann, Dr. med.; Phone Number: +49 (511) 532-2379; Email: hamann.max@mh-hannover.de
  • Lübeck, Germany, 23538
    • Not yet recruiting
    • Department of Ophthalmology, University Medical Center Schleswig-Holstein
    • Contact: Miura Yoko, Prof. Dr. med.; Phone Number: +49 451 3101 3212; Email: yoko.miura@uni-luebeck.de
  • Potsdam, Germany, 14467
    • Not yet recruiting
    • Potsdam Eye Clinic at Gräfehaus
    • Contact: Volker Rasch, Dr. med.; Phone Number: +49 331 280860; Email: macutherm@graefe-haus.de
  • Schleswig, Germany, 24837
    • Recruiting
    • AugenNord Medical Practice and Surgical Center
    • Contact: Imke Biedermann, Dr. med.; Phone Number: +49 4351 72 75 0; Email: macutherm@augennord.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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

Exclusion Criteria:

• Presence of late-stage AMD, neovascular (nAMD, active or fibrotic) or geographic atrophy (GA)
• Maculopathies showing only pseudodrusen
• Any systemic medication known to be toxic to the lens, retina or optic nerve
• Any intraocular surgery within 6 months prior to study inclusion (except uncomplicated cataract surgery > 3 months)
• Any previous thermal laser treatment in the macula
• History of vitrectomy, filter surgery, corneal transplantation or retinal detachment
• Previous therapeutic radiotherapy in the eye region
• Pregnant or breast-feeding patients
• Participation in an investigational drug, biologic or device study within 6 months prior to study entry (Note: observational clinical studies involving only over-the-counter vitamins, supplements or diets are not excluded)
• Expected participation in an investigational drug, biologic or device study during the duration of this clinical investigation except clinical investigations for diagnostic purposes where examinations are not influencing the outcome of the current clinical investigation. Mandatory for participation in this additional clinical investigation is prior approval from the sponsor of this clinical investigation in writing
• A serious medical condition that prevents the patient from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinological, neurological or haematological conditions) or, in the opinion of the investigator, is likely to require surgery or hospitalization (at any time during his/her participation on this clinical investigation)
• Known allergy to any ingredient required (for dilation of the pupil, if no alternative agent may be applied) or any contraindication to be treated with Navilas® Laser System 577SL
• If, in the opinion of the investigator, it is unlikely that the study protocol will be followed

If only one eye is eligible for inclusion, none of the following criteria must be present in the fellow eye in order to allow inclusion of the study eye:

• Presence of late-stage AMD in need of therapy
• Presence of neovascular AMD (nAMD) in need of therapy
• Presence of geographic atrophy (GA) in need of therapy (e.g. complement-inhibitors)
• All the non-AMD eye diseases mentioned for the study eye as exclusion criteria
• Previous therapeutic radiotherapy in the fellow eye region

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group	Device: Sham treatment; Patients receive sham treatment in the study eye
Experimental: Treatment Group	Device: photothermal therapy; Patients receive individualized photothermal therapy in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI).	It is reached if at 12 months the EZI change from baseline is significantly better in the Treatment Group than in the Control Group.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in eyes of Treatment Group compared to eyes in Control Group compared to baseline to determine progression of Drusen within ETDRS sector (<6mm)	24 months
Rate of eyes converting to geographic atrophy	24 months
Rate of eyes converting to active exudative nAMD	24 months
Loss in BCVA of > 3 lines compared to baseline	24 months

Collaborators and Investigators

• Sponsor: OD-OS MacuTherm GmbH
• Investigators: Principal Investigator: Jan Tode, Prof. Dr. med., OD-OS MacuTherm GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: iAMD; MacuTherm Trial
• Additional Relevant MeSH Terms: Therapeutics; Hyperthermia, Induced; Phototherapy; Photothermal Therapy
• Other Study ID Numbers: MacuTherm Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not planned to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No