Actively Recruiting
Individualized Navigated Photothermal Therapy in Patients With Intermediate AMD: A Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Performance of the Therapy Proposed by Macula Explorer Using Navilas Laser System
Led by OD-OS MacuTherm GmbH · Updated on 2026-06-04
240
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate photothermal therapy using the Macula Explorer's individualized treatment plan delivered by the Navilas® Laser System for people with intermediate Age-related Macular Degeneration (iAMD). The study seeks to determine if this therapy can safely improve photoreceptor health and slow disease progression, measured by Ellipsoid Zone Integrity (EZI). Participants aged 60 to 90 years with clinically confirmed intermediate AMD are included. Participants will be randomly assigned to either the Treatment Group receiving the photothermal therapy or the Control Group receiving a sham treatment. The study involves 12 visits over two years: monthly visits for the first three months followed by quarterly visits until study completion. The therapy is delivered directly to the study eye using the Navilas® Laser System. Throughout the study, participants will undergo assessments to monitor vision and retinal health, including the primary measure of EZI preservation at 12 months. Secondary measures include drusen progression, rates of conversion to geographic atrophy or neovascular AMD, and loss of visual acuity over 24 months. Researchers will track safety and treatment effects across scheduled visits during the two-year follow-up.
CONDITIONS
Brief Title
MacuTherm Performance Study in Patients With iAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, or diverse gender
- Age between 60 and 90 years old
- Clinically confirmed intermediate AMD (AREDS category 3) with at least 3 large drusen (>125 µm) in the inner 3mm ETDRS grid centered on the fovea
- Presence of incomplete RPE and outer retinal atrophy outside central 1mm and/or hyperreflective foci adjacent to drusen within 3 mm
- Best corrected visual acuity between 65 and 87 letters
- Clear optic media
- Ability to communicate clearly and understand study requirements
- Ability to provide written informed consent
- Willingness to participate in the study
You will not qualify if you...
- Presence of late-stage AMD, neovascular or geographic atrophy
- Maculopathies with only pseudodrusen
- Use of systemic medication toxic to lens, retina, or optic nerve
- Intraocular surgery within 6 months prior (except uncomplicated cataract surgery over 3 months ago)
- 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 breastfeeding
- Participation in another investigational drug, biologic, or device study within 6 months
- Planned participation in another investigational study during this trial without sponsor approval
- Serious medical conditions preventing study activities or likely requiring surgery or hospitalization
- Known allergy to any agent required for pupil dilation or contraindication to Navilas® Laser System
- Unlikely protocol adherence as judged by the investigator
- Late-stage AMD or other exclusion eye diseases in the fellow eye if only one eye is eligible
- Previous therapeutic radiotherapy in the fellow eye region
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either individualized photothermal therapy or sham treatment in the study eye using the Navilas Laser System.
1 treatment visit (in-person)
Duration - Up to 24 months
Participants are monitored for up to 24 months after treatment to assess preservation of eye structure and function.
Periodic follow-up visits over 24 months
Trial Site Locations
Total: 4 locations
1
Department of Ophthalmology at Hannover Medical School
Hanover, Germany, 30625
Not Yet Recruiting
2
Department of Ophthalmology, University Medical Center Schleswig-Holstein
Lübeck, Germany, 23538
Not Yet Recruiting
3
Potsdam Eye Clinic at Gräfehaus
Potsdam, Germany, 14467
Not Yet Recruiting
4
AugenNord Medical Practice and Surgical Center
Schleswig, Germany, 24837
Actively Recruiting
Research Team
J
Jan Tode, Prof. Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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