MacuTherm Performance Study in Patients With iAMD

NCT07607496 | Recruiting DMC

• 1 other identifier: MacuTherm Trial
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

MacuTherm Trial; iAMD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Device: photothermal therapy

Control Group

SHAM COMPARATOR

Device: Sham treatment

Interventions

photothermal therapy DEVICE

Patients receive individualized photothermal therapy in the study eye

Treatment Group

Sham treatment DEVICE

Patients receive sham treatment in the study eye

Control Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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)

Sponsors & Collaborators

• OD-OS MacuTherm GmbH: lead

Study Sites (4)

Department of Ophthalmology at Hannover Medical School

Hanover, 30625, Germany

NOT YET RECRUITING

Department of Ophthalmology, University Medical Center Schleswig-Holstein

Lübeck, 23538, Germany

NOT YET RECRUITING

Potsdam Eye Clinic at Gräfehaus

Potsdam, 14467, Germany

RECRUITING

AugenNord Medical Practice and Surgical Center

Schleswig, 24837, Germany

RECRUITING

MeSH Terms

Interventions

Photothermal Therapy

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Phototherapy

Study Officials

• Jan Tode, Prof. Dr. med.

  OD-OS MacuTherm GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Tode, Prof. Dr. med.

CONTACT

+49 3328 31 282-100; Jan.Tode@od-os.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)