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NCT Number: NCT07305298

Mirabegron in Patients With Age-Related Macular Degeneration

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

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Key information

Conditions

Dry AMD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Primary outcomes

  1. Changes in outer retinal morphology using SD-OCT

    Time frame: "From enrollment to the end of treatment at 12 months

    Outer nuclear layer (ONL) thickness, choroidal thickness (ChT), central macular thickness (CMT) will all be measured in micron

  2. Changes in FAF assessing

    Time frame: "From enrollment to the end of treatment at 12 months

    changes in FAF measured in micron

Secondary outcomes

  1. mean BCVA

    Time frame: From enrollment to the end of treatment at 12 months

    Mean BCVA according to the ETDRS charts

  2. Mean macular sensitivity (MS)

    Time frame: From enrollment to the end of treatment at 12 months

Other outcomes

  1. Safety parameters

    Time frame: From enrollment to the end of treatment at 12 months

    blood pressure measured in mmHg

  2. Safety parameters

    Time frame: From enrollment to the end of treatment at 12 months

    heart frequency in bpm

  3. Safety parameters

    Time frame: From enrollment to the end of treatment at 12 months

    SpO2 (Peripheral Oxygen Saturation) in % saturation

  4. Safety parameters

    Time frame: From enrollment to the end of treatment at 12 months

    Respiratory rate in dpm

Study contacts

Contact information is provided by the study sponsor or research team.

Mario D Toro, Professor

CONTACT

[email protected]

+393495158220

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Collaborators

  • Medical University of Lublin

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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