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Not yet recruiting NCT07305298

Mirabegron in Patients With Age-Related Macular Degeneration

— Observational Dry AMD Overactive Bladder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirabegron 50mg, Solifenacin 5mg.
Who it may be relevant to
Registry conditions: Dry AMD, Overactive Bladder. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Mirabegron in Patients With Age-Related Macular Degeneration Treated for Overactive Bladder: A Study Protocol for a Non-Randomized Prospective Controlled Trial

Overview

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

Interventions

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

Primary outcome measures

  • Changes in outer retinal morphology using SD-OCT [Time frame: "From enrollment to the end of treatment at 12 months]
  • Changes in FAF assessing [Time frame: "From enrollment to the end of treatment at 12 months]
Secondary outcome measures (2)
  • mean BCVA [Time frame: From enrollment to the end of treatment at 12 months]
  • Mean macular sensitivity (MS) [Time frame: From enrollment to the end of treatment at 12 months]

Eligibility criteria

Inclusion criteria

  • Age subjects 50 and 80 years-old
  • Ability to express informed consent
  • Early or moderate dry AMD according to ARDS classification
  • Overreactive bladder
  • Visual acuity greater than BCVA 65 EDTRS letters.

Exclusion criteria

  • • Any medical condition which contraindicates the use of beta-agonists
  • Uncontrolled hypertension
  • Tachycardia or atrial fibrillation
  • Any allergies to the beta-agonists
  • Renal or hepatic failure
  • Long QT or concomitant treatment with drugs that cause lengthening of the QT interval
  • Any sign of ocular inflammation
  • xudative AMD
  • Any ongoing medical or surgical treatment for AMD (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
  • Any other ophthalmic diseases such glaucoma, acute or chronic uveitis, advanced cataract, or any opacities of the ocular media that do not permit high-quality imaging examinations.
  • Pregnancy
  • Any condition or disease that in the opinion of the investigators may put the subject at significant risk or may interfere significantly with the subject's participation in the study (i. e. malignancy, uncontrolled or cardiovascular diseases)

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

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • Federico II — Naples

Publications

  • Ambrosio L, Cammalleri M, Panariello S, Califano G, Scala A, Improta G, Pisani A, Rejdak R, Ostrowski I, Filippi L, Bagnoli P, Dal Monte M, Toro MD. Mirabegron in patients with age-related macular degeneration treated for overactive bladder: a study protocol for a prospective observational non-randomized trial. Front Med (Lausanne). 2026 Mar 16;13:1761473. doi: 10.3389/fmed.2026.1761473. eCollecti PMID 41919172

Identifiers

NCT: NCT07305298 · 2025a45673

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗