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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Patients receive individualized photothermal therapy in the study eye
Patients receive sham treatment in the study eye
Department of Ophthalmology at Hannover Medical School
Hanover, Germany
NOT_YET_RECRUITINGDepartment of Ophthalmology, University Medical Center Schleswig-Holstein
Lübeck, Germany
NOT_YET_RECRUITINGPotsdam Eye Clinic at Gräfehaus
Potsdam, Germany
NOT_YET_RECRUITINGPrimary 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.
Time frame: 12 months
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
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AugenNord Medical Practice and Surgical Center
Schleswig, Germany
RECRUITING