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Mirabegron in Patients With Age-Related Macular Degeneration

NCT ID: NCT07305298

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Dry AMD Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mirabegron arm

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

Group Type EXPERIMENTAL

Mirabegron 50mg

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Solifenacin 5mg

Intervention Type DRUG

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

Interventions

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Mirabegron 50mg

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

Intervention Type DRUG

Solifenacin 5mg

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

Intervention Type DRUG

Eligibility Criteria

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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 40 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role collaborator

University of Naples

OTHER

Sponsor Role lead

Responsible Party

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Mario Damiano Toro

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federico II

Naples, , Italy

Site Status

Countries

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Italy

Central Contacts

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Mario D Toro, Professor

Role: CONTACT

Phone: +393495158220

Email: [email protected]

Other Identifiers

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2025a45673

Identifier Type: -

Identifier Source: org_study_id