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Clinical Trials in Italy / NCT07305298
Starting soon Observational

Mirabegron in Patients With Age-Related Macular Degeneration

NCT07305298 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Naples
Phase
Observational
Started
2026-04-01
Last updated
2026-02-06

Condition(s) studied

Dry AMDOveractive Bladder

Investigational drug(s) / intervention(s)

Mirabegron 50mg →Solifenacin 5mg →

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

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

Study 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

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Changes in outer retinal morphology using SD-OCT — "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
  • Changes in FAF assessing — "From enrollment to the end of treatment at 12 months
    changes in FAF measured in micron

Trial sites (1)

FacilityCityRegionStatus
Federico II Naples Italy

Other trials for the same condition

Tensi+ European Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07305298 on ClinicalTrials.gov ↗ ← All trials in Italy