Dry AMD, Overactive Bladder
Conditions
Brief 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
Interventions
DRUGMirabegron 50mg
Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
DRUGSolifenacin 5mg
Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)
Sponsors
University of Naples
Medical University of Lublin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean BCVA | From enrollment to the end of treatment at 12 months | Mean BCVA according to the ETDRS charts |
| Mean macular sensitivity (MS) | From enrollment to the end of treatment at 12 months | — |
Countries
Italy
Contacts
CONTACTMario D Toro, Professor
Outcome results
None listed