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| Name | Class |
|---|---|
| Medical University of Lublin | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron arm | Mirabegron will be administered per os at the dose of 50 mg/day for 12 months |
| |
| Control arm | Solifenacin will be administered per os at the dose of 5mg/day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron 50mg | Drug | Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | "From enrollment to the end of treatment at 12 months |
| Changes in FAF assessing | changes in FAF measured in micron | "From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| mean BCVA | Mean BCVA according to the ETDRS charts | From enrollment to the end of treatment at 12 months |
| Mean macular sensitivity (MS) | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters | blood pressure measured in mmHg | From enrollment to the end of treatment at 12 months |
| Safety parameters | heart frequency in bpm |
Inclusion Criteria:
Exclusion Criteria:
• Any medical condition which contraindicates the use of beta-agonists
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subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario D Toro, Professor | Contact | +393495158220 | mariodamiano.toro@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II | Naples | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41919172 | Derived | Ambrosio L, Cammalleri M, Panariello S, Califano G, Scala A, Improta G, Pisani A, Rejdak R, Ostrowski I, Filippi L, Bagnoli P, Dal Monte M, Toro MD. Mirabegron in patients with age-related macular degeneration treated for overactive bladder: a study protocol for a prospective observational non-randomized trial. Front Med (Lausanne). 2026 Mar 16;13:1761473. doi: 10.3389/fmed.2026.1761473. eCollection 2026. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Solifenacin 5mg | Drug | Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder) |
|
| From enrollment to the end of treatment at 12 months |
| Safety parameters | SpO2 (Peripheral Oxygen Saturation) in % saturation | From enrollment to the end of treatment at 12 months |
| Safety parameters | Respiratory rate in dpm | From enrollment to the end of treatment at 12 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |