Dry AMDNCT07305298
Mirabegron in Patients With Age-Related Macular Degeneration
An observational study of Dry AMD and Overactive Bladder, run by University of Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dry AMD, Overactive Bladder
- What is being tested?
- Mirabegron 50mg and Solifenacin 5mg
- How many people
- 312 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin
Who may be able to join
- 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.
Who cannot join
- • 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mirabegron in Patients With Age-Related Macular Degeneration Treated for Overactive Bladder: A Study Protocol for a Non-Randomized Prospective Controlled 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
- Conditions
- Dry AMD, Overactive Bladder
- Being tested
- Mirabegron 50mg, Solifenacin 5mg
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 50mgDrug
Mirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm)
Solifenacin 5mgDrug
Solifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder)
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron arm | Mirabegron will be administered per os at the dose of 50 mg/day for 12 months Receives: Drug: Mirabegron 50mg | |
| Control arm | Solifenacin will be administered per os at the dose of 5mg/day for 12 months Receives: Drug: Solifenacin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "From enrollment to the end of treatment at 12 months
Changes in FAF assessing
changes in FAF measured in micron
Measured: "From enrollment to the end of treatment at 12 months
Secondary outcomes (2)
mean BCVA
Mean BCVA according to the ETDRS charts
Measured: From enrollment to the end of treatment at 12 months
Mean macular sensitivity (MS)
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lublin
- Responsible party
- Principal investigator, Mario Damiano Toro, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305298
- Sponsor's protocol ID
- 2025a45673
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41919172
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirabegron in Patients With Age-Related Macular Degeneration Treated for Overactive Bladder: A Study Protocol for a Non-Randomized Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT07305298
- Acronym / sponsor ID
- 2025a45673
- Conditions
- Dry AMD, Overactive Bladder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Collaborators
- Medical University of Lublin
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron arm | – | Drug: Mirabegron 50mgMirabegron will be administered per os at the dose of 50 mg/day for 12 months |
| Control arm | – | Drug: Solifenacin 5mgSolifenacin will be administered per os at the dose of 5mg/day for 12 months |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects aged between 50 and 80 years-old with early or moderate dry AMD and overreactive bladder treated with either Mirabegron or Solifenacin
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- • Any medical condition which contraindicates the use of beta-agonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 50mgMirabegron (50mg/day per os) will be administered in patients with dry AMD and overactive bladder (MMirabegron arm) | Drug | Mirabegron arm |
| Solifenacin 5mgSolifenacin (5mg/day per os) will be administered in control group (dry amd and overactive bladder) | Drug | Control arm |
Primary outcome
Changes in outer retinal morphology using SD-OCT
Time frame: "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
Time frame: "From enrollment to the end of treatment at 12 months
changes in FAF measured in micron
2 secondary outcomes
mean BCVA
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 41919172Ambrosio 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.
Related trials for Dry AMD
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
Not yet recruiting
MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
Age-Related Macular Degeneration (AMD)
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry AMD and Overactive Bladder, run by University of Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario D Toro, Professor (+393495158220, mariodamiano.toro@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in outer retinal morphology using SD-OCT (time frame: "From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07305298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.