Mirabegron in Patients With Age-Related Macular Degeneration

Sponsor
University of Naples
Study ID
NCT07305298
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirabegron 50mg — DRUG
    Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
  • Solifenacin 5mg — DRUG
    Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)

Study Details

The goal of this clinical trial is to learn if Mirabegron works to treat dry AMD in patients, aged between 50 and 80 years-old, with early or moderate dry AMD and overactive bladder. The main question it aims to answer is: • Is there any change in outer retina morphology in patients treated? Researchers will compare the safety and efficacy of mirabegron versus conventional approach (Solifenacin) to treat dry AMD in patients with dry AMD and overactive bladder. Participants will: * Take Mirabegron or Solifenacin every day for 12 months * Visit the clinic once every 6 months for checkups and tests

Key Dates

First listed
Dec 26, 2025
Start date
Apr 1, 2026
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
312 participants (estimated)

Arms

  • Arm: Mirabegron arm
    Mirabegron will be administered per os at the dose of 50 mg/day for 12 months
  • Arm: Control arm
    Solifenacin will be administered per os at the dose of 5mg/day for 12 months

Primary Outcome Measure

Changes in outer retinal morphology using SD-OCT [ Time Frame: "From enrollment to the end of treatment at 12 months ]

Central Contacts

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