An observational study in Dry AMD and Overactive Bladder, sponsored by University of Naples. Not yet recruiting at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University of Naples · Observational
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:
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:
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 312 is above the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of Naples is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin
Exclusion Criteria:
Any medical condition which contraindicates the use of beta-agonists
Mirabegron will be administered per os at the dose of 50 mg/day for 12 months
Drug: Mirabegron 50mg
Solifenacin will be administered per os at the dose of 5mg/day for 12 months
Drug: Solifenacin 5mg
Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)
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
Time frame: "From enrollment to the end of treatment at 12 months
Changes in FAF assessing
changes in FAF measured in micron
Time frame: "From enrollment to the end of treatment at 12 months
mean BCVA
Mean BCVA according to the ETDRS charts
Time frame: From enrollment to the end of treatment at 12 months
Mean macular sensitivity (MS)
Time frame: From enrollment to the end of treatment at 12 months
Safety parameters
blood pressure measured in mmHg
Time frame: From enrollment to the end of treatment at 12 months
Safety parameters
heart frequency in bpm
Time frame: From enrollment to the end of treatment at 12 months
Safety parameters
SpO2 (Peripheral Oxygen Saturation) in % saturation
Time frame: From enrollment to the end of treatment at 12 months
Safety parameters
Respiratory rate in dpm
Time frame: From enrollment to the end of treatment at 12 months
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Naples