MacuTherm Performance Study in Patients With iAMD

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Study sites: 9 to 10
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Trial sites expanded: 4 → 9 locationsv4
  3. Site details revised at 1 of 4 sitesv3
  4. Recruitment opened
    • Start date changed from estimate of May 2026 to May 29, 2026
    • Site details revised at 4 of 4 sites
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07607496
Lead Sponsor OD-OS MacuTherm GmbH
Conditions
(from sponsor)		 Intermediate AMD
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov