MacuTherm Performance Study in Patients With iAMD
ConditionIntermediate AMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorOD-OS MacuTherm GmbH
About this trial
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.
Eligibility criteria
Qualifiers
Male, female, or diverse
Age of 60 to 90 years old
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))
Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and/or
Disqualifiers
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)
Trial design
Treatments tested in this trial
- photothermal therapy
- Sham treatment
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov