Mirabegron in Patients With Age-Related Macular Degeneration

University of Naples

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Dry AMD; Overactive Bladder

Treatments: Drug: Mirabegron 50mg; Drug: Solifenacin 5mg

Study type: Observational

Funder types: Other

Identifiers

NCT07305298

2025a45673

Details and patient eligibility

About

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

Enrollment: 312 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

312 participants in 2 patient groups

Mirabegron arm

Description:

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

Treatment:

Drug: Mirabegron 50mg

Control arm

Description:

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

Treatment:

Drug: Solifenacin 5mg