Not Yet RecruitingNot Applicable

Mirabegron in Patients With Age-Related Macular Degeneration

Italy312 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range50 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Changes in outer retinal morphology using SD-OCT

Timeframe: "From enrollment to the end of treatment at 12 months

Changes in FAF assessing

Timeframe: "From enrollment to the end of treatment at 12 months

Trial details

NCT IDNCT07305298

SponsorUniversity of Naples

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

Contact for this trial

Mario D Toro, Professor

+393495158220 mariodamiano.toro@unina.it

View on ClinicalTrials.gov More Dry AMD trials