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
- Are there results?
- Not yet: the study is under way
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
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- 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
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- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07607496
- Acronym / sponsor ID
- MacuTherm Trial
- Conditions
- Intermediate AMD
- Keywords
- MacuTherm Trial, iAMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- OD-OS MacuTherm GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: photothermal therapy |
| Control Group | Sham comparator | Device: Sham treatment |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male, female, or diverse
- Age of 60 to 90 years old
- Clinically confirmed intermediate AMD (iAMD, AREDS category 3) with the presence of:
- Best corrected visual acuity between 65 and 87 letters
- Clear optic media
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photothermal therapyPatients receive individualized photothermal therapy in the study eye | Device | Treatment Group |
| Sham treatmentPatients receive sham treatment in the study eye | Device | Control Group |
Primary outcome
Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI).
Time frame: 12 months
It is reached if at 12 months the EZI change from baseline is significantly better in the Treatment Group than in the Control Group.
4 secondary outcomes
Change in eyes of Treatment Group compared to eyes in Control Group compared to baseline to determine progression of Drusen within ETDRS sector (<6mm)
Time frame: 24 months
Rate of eyes converting to geographic atrophy
Time frame: 24 months
Rate of eyes converting to active exudative nAMD
Time frame: 24 months
Loss in BCVA of > 3 lines compared to baseline
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. It is not planned to share individual participant data.
Related trials for Intermediate AMD
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A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Tode, Prof. Dr. med. principal investigator
OD-OS MacuTherm GmbH
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photothermal therapy in people with Intermediate AMD, run by OD-OS MacuTherm GmbH at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Tode, Prof. Dr. med. (+49 3328 31 282-100, Jan.Tode@od-os.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.