Mirabegron in Patients With Age-Related Macular Degeneration

NCT07305298 | Not Yet Recruiting

• 1 other identifier: 2025a45673
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry AMD; Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• mean BCVA

  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 Outcomes (4)

• Safety parameters

  From enrollment to the end of treatment at 12 months

• Safety parameters

  From enrollment to the end of treatment at 12 months

• Safety parameters

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Mirabegron arm

Mirabegron will be administered per os at the dose of 50 mg/day for 12 months

Drug: Mirabegron 50mg

Control arm

Solifenacin will be administered per os at the dose of 5mg/day for 12 months

Drug: Solifenacin 5mg

Interventions

Mirabegron 50mg DRUG

Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)

Mirabegron arm

Solifenacin 5mg DRUG

Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)

Control arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Naples: lead
• Medical University of Lublin: collaborator

Study Sites (1)

Federico II

Naples, Italy

Location

Related Publications (1)

• 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. eCollection 2026.

  PMID: 41919172 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Solifenacin Succinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mario D Toro, Professor

CONTACT

+393495158220; mariodamiano.toro@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 26, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-12

Locations

IT (1)