MacuTherm Performance Study in Patients With iAMD

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

Overview

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.

Interventions

• Device photothermal therapy
  Patients receive individualized photothermal therapy in the study eye
• Device Sham treatment
  Patients receive sham treatment in the study eye

Primary outcome measures

• Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI). [Time frame: 12 months]

Secondary outcome measures (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) [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Germany · 4 centers

• Department of Ophthalmology at Hannover Medical School — Hanover
• Department of Ophthalmology, University Medical Center Schleswig-Holstein — Lübeck
• Potsdam Eye Clinic at Gräfehaus — Potsdam
• AugenNord Medical Practice and Surgical Center — Schleswig

Identifiers

NCT: NCT07607496 · MacuTherm Trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗