BridgeMD
New treatment option for Intermediate AMD
Official title MacuTherm Performance Study in Patients With iAMD
ClinicalTrials.gov ID: NCT07607496
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- 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...
- combined with at least 1 of the following other signs:
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Germany
- Lübeck, Germany
- Potsdam, Germany
- Schleswig, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Germany; Lübeck, Germany; Potsdam, Germany; Schleswig, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.