Personalized Photothermal Therapy Using Navilas Laser for Intermediate Age-Related Macular Degeneration in Adults Aged 60 to 90

What this Trial Is About

Researchers are evaluating photothermal therapy using the Navilas Laser System for people aged 60 to 90 with intermediate Age-related Macular Degeneration iAMD. The study aims to show that this personalized treatment plan can safely improve photoreceptor health and slow disease progression by preserving the Ellipsoid Zone Integrity EZI. Participants will be randomized into either a treatment group or a control group to compare outcomes over time. Participants will receive either individualized photothermal therapy or a sham treatment in the study eye. The study involves 12 visits monthly visits during the first three months, followed by quarterly visits for up to two years. The primary measure of success is the preservation of EZI at 12 months, with additional outcomes including changes in drusen progression, rates of geographic atrophy or neovascular AMD development, and vision loss measured over 24 months. During the study, participants will undergo regular eye exams and assessments to monitor vision and retinal health. Researchers will measure visual acuity changes and track disease progression using imaging and clinical evaluations. The study includes safety monitoring and thorough follow-up across the two-year period to assess long-term effects of the treatment on intermediate AMD progression.

MacuTherm Performance Study in Patients With iAMD