Mirabegron in Patients With Age-Related Macular Degeneration

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Dry AMD
• Intervention / Treatment: Drug: Mirabegron 50mg; Drug: Solifenacin 5mg

• Study Type: Observational
• Enrollment (Estimated): 312
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mario D Toro, Professor; Phone Number: +393495158220; Email: mariodamiano.toro@unina.it

Study Locations

• Italy
  • Naples, Italy
    • Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mirabegron arm; Mirabegron will be administered per os at the dose of 50 mg/day for 12 months	Drug: Mirabegron 50mg; Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
Control arm; Solifenacin will be administered per os at the dose of 5mg/day for 12 months	Drug: Solifenacin 5mg; Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in outer retinal morphology using SD-OCT	Outer nuclear layer (ONL) thickness, choroidal thickness (ChT), central macular thickness (CMT) will all be measured in micron	"From enrollment to the end of treatment at 12 months
Changes in FAF assessing	changes in FAF measured in micron	"From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean BCVA	Mean BCVA according to the ETDRS charts	From enrollment to the end of treatment at 12 months
Mean macular sensitivity (MS)		From enrollment to the end of treatment at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters	blood pressure measured in mmHg	From enrollment to the end of treatment at 12 months
Safety parameters	heart frequency in bpm	From enrollment to the end of treatment at 12 months
Safety parameters	SpO2 (Peripheral Oxygen Saturation) in % saturation	From enrollment to the end of treatment at 12 months
Safety parameters	Respiratory rate in dpm	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: University of Naples
• Collaborators: Medical University of Lublin

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Solifenacin Succinate; mirabegron
• Other Study ID Numbers: 2025a45673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No