Laser therapy aims to preserve sight in AMD patients
NCT ID NCT07607496
First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 5 times
Summary
This study tests whether a targeted laser treatment, called photothermal therapy, can slow the progression of intermediate age-related macular degeneration (AMD). About 240 people aged 60–90 with intermediate AMD will receive either the laser or a sham procedure. The main goal is to see if the treatment preserves the health of light-sensing cells in the eye over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- photothermal therapy (laser treatment)
- What this could lead to
- If successful, this laser treatment could slow the progression of intermediate AMD and help preserve vision longer.
- What could go wrong
- This is an early-stage trial with no phase assigned, so results are uncertain. The treatment may not slow vision loss or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AugenNord Medical Practice and Surgical Center
RECRUITINGSchleswig, 24837, Germany
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Augenklinik Universitätsmedizin Mannheim, Department Augenheilkunde
RECRUITINGMannheim, 68167, Germany
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Augenklinik am St. Franziskus-Hospital Münster
RECRUITINGMünster, 48145, Germany
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Department of Ophthalmology at Hannover Medical School
NOT_YET_RECRUITINGHanover, 30625, Germany
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Department of Ophthalmology, University Medical Center Schleswig-Holstein
RECRUITINGLübeck, 23538, Germany
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Gemeinschaftspraxis GbR Dr. Giers, Dr. Faßbender & Partner
RECRUITINGDetmold, 32756, Germany
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MVZ Augenklinik Petrisberg GmbH, Klinik und Praxis für Augenheilkunde
RECRUITINGTrier, 54296, Germany
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Potsdam Eye Clinic at Gräfehaus
RECRUITINGPotsdam, 14467, Germany
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Praxis Zschopau I
RECRUITINGZschopau, 09405, Germany
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