Mirabegron in Patients With Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorUniversity of Naples
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age subjects 50 and 80 years-old
Ability to express informed consent
Early or moderate dry AMD according to ARDS classification
Overreactive bladder
Disqualifiers
• Any medical condition which contraindicates the use of beta-agonists
Uncontrolled hypertension
Tachycardia or atrial fibrillation
Any allergies to the beta-agonists
Trial population
subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Mirabegron 50mg
DrugMirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
Solifenacin 5mg
DrugSolifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: Mirabegron arm1 intervention
Group B: Control arm1 intervention
Trial outcomes
Primary outcomes
1
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 months2
Changes in FAF assessing
changes in FAF measured in micron
Time frame
"From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
mean BCVA
Mean BCVA according to the ETDRS charts
Time frame
From enrollment to the end of treatment at 12 months2
Mean macular sensitivity (MS)
Time frame
From enrollment to the end of treatment at 12 monthsOther outcomes
1
Safety parameters
blood pressure measured in mmHg
Time frame
From enrollment to the end of treatment at 12 months2
Safety parameters
heart frequency in bpm
Time frame
From enrollment to the end of treatment at 12 months3
Safety parameters
SpO2 (Peripheral Oxygen Saturation) in % saturation
Time frame
From enrollment to the end of treatment at 12 months4
Safety parameters
Respiratory rate in dpm
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Naples
Lead sponsor
Medical University of Lublin
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: