Intermediate AMDNCT07607496
MacuTherm Performance Study in Patients With iAMD
A study testing photothermal therapy in people with Intermediate AMD, run by OD-OS MacuTherm GmbH at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Intermediate AMD
- What is being tested?
- photothermal therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 May 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Germany9 sites, 9 recruiting
- Recruiting
Gemeinschaftspraxis GbR Dr. Giers, Dr. Faßbender & Partner
Detmold, 32756
Jana Riedl, Dr. med.
- Recruiting
Department of Ophthalmology at Hannover Medical School
Hanover, 30625
Maximilian LJ Hamann, Dr. med., +49 (511) 532-2379, hamann.max@mh-hannover.de
- Recruiting
Department of Ophthalmology, University Medical Center Schleswig-Holstein
Lübeck, 23538
Miura Yoko, Prof. Dr. med., +49 451 3101 3212, yoko.miura@uni-luebeck.de
- Recruiting
Augenklinik Universitätsmedizin Mannheim, Department Augenheilkunde
Mannheim, 68167
Robert Finger, Prof. Dr. Dr. med.
- Recruiting
Augenklinik am St. Franziskus-Hospital Münster
Münster, 48145
Georg Spital, Dr. med.
- Recruiting
Potsdam Eye Clinic at Gräfehaus
Potsdam, 14467
Volker Rasch, Dr. med., +49 331 280860, macutherm@graefe-haus.de
- Recruiting
AugenNord Medical Practice and Surgical Center
Schleswig, 24837
Imke Biedermann, Dr. med., +49 4351 72 75 0, macutherm@augennord.de
- Recruiting
MVZ Augenklinik Petrisberg GmbH, Klinik und Praxis für Augenheilkunde
Trier, 54296
Kai Januschowski, Prof. Dr. med.
- Recruiting
Praxis Zschopau I
Zschopau, 09405
Simo Murovski, Dr. med.
United Kingdom1 site, 1 recruiting
- Recruiting
South Tyneside & Sunderland NHS Foundation Trust
Sunderland
Maged Habib, Prof.
About this study
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
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
- Being tested
- photothermal therapy, Sham treatment
- Keywords
- MacuTherm Trial, iAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photothermal therapyDevice
Patients receive individualized photothermal therapy in the study eye
Sham treatmentDevice
Patients receive sham treatment in the study eye
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: photothermal therapy |
| Control Group | Sham comparator | Not described Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 24 months
Rate of eyes converting to geographic atrophy
Measured: 24 months
Rate of eyes converting to active exudative nAMD
Measured: 24 months
Loss in BCVA of > 3 lines compared to baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start29 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OD-OS MacuTherm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tode, Prof. Dr. med., Principal investigator, OD-OS MacuTherm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607496
- Sponsor's protocol ID
- MacuTherm Trial
- Status last verified
- Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share individual participant data.