Age-Related (Dry) Macular DegenerationMIND-AMDNCT07847151
MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.
An observational study of Age-Related (Dry) Macular Degeneration and Age-Related Macular Degeneration (AMD), run by IRCCS San Raffaele.
Trial summary
Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD), AMD Population - Intermediate or Advanced AMD
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2027to 2 Jan 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by intermediate, wet and dry (geographic atrophy) age-related macular degeneration (AMD) and healthy age- and gender-matched controls
Who may be able to join
- Confirmed diagnosis of AMD
Who cannot join
- low BCVA (<20/100)
- other ocular diseases
- uncontrolled systemic diseases potentially affecting data interpretation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Adelaide Pina, MsC contact
About this study
Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Despite the available treatments, the visual outcome is highly heterogeneous. The scientific interest is growing regarding the assessment of neuroretinal changes in AMD. Although AMD is mainly considered an outer retinal disease, recent evidence suggests a major involvement of retinal glia and neurons, i.e. an involvement of the inner retina. This damage may remarkably affect the morphological and functional AMD outcome, subverting retinal signal transmission cascade and more clearly explaining the outcome of the disease. The main goal of this study is to perform a multidisciplinary, multicenter, both prospective and retrospective evaluation of neuroretinal degeneration in different AMD stages in preclinical and clinical models.
- Conditions
- Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD), AMD Population - Intermediate or Advanced AMD, AMD and Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration
- Keywords
- Age-related macular degeneration, Multimodal retinal imaging, Mouse model, microRNA
- Medical subject headings
- Macular Degeneration, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by AMD (different stages) | Patients affected by intermediate, wet and dry atrophic AMD | |
| Healthy controls | Healthy age- and gender-matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroretinal degeneration quantitative metrics
Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
Measured: From January 2027 to January 2030
Imaging metrics of neuroretinal changes
Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
Measured: From January 2027 to January 2030
MicroRNA profiles associated with AMD stages
MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration.
Measured: From January 2027 to January 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start2 Jan 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Age-Related (Dry) Macular DegenerationStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Arrigo, IRCCS San Raffaele
- Investigators
- Alessandro Arrigo, MD, PhD, Principal investigator, IRCCS San Raffaele Scientific Institute, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847151
- Sponsor's protocol ID
- MIND-AMD
- Other IDs
- GR-2024-12379726
- Acronym
- MIND-AMD
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific publications and international conferences.
Publications
Natoli R, Fernando N. MicroRNA as Therapeutics for Age-Related Macular Degeneration. Adv Exp Med Biol. 2018;1074:37-43. doi: 10.1007/978-3-319-75402-4_5.
PubMed 29721925Nassisi M, Fan W, Shi Y, Lei J, Borrelli E, Ip M, Sadda SR. Quantity of Intraretinal Hyperreflective Foci in Patients With Intermediate Age-Related Macular Degeneration Correlates With 1-Year Progression. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3431-3439. doi: 10.1167/iovs.18-24143.
PubMed 30025092Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
PubMed 30794627Nassisi M, Lei J, Abdelfattah NS, Karamat A, Balasubramanian S, Fan W, Uji A, Marion KM, Baker K, Huang X, Morgenthien E, Sadda SR. OCT Risk Factors for Development of Late Age-Related Macular Degeneration in the Fellow Eyes of Patients Enrolled in the HARBOR Study. Ophthalmology. 2019 Dec;126(12):1667-1674. doi: 10.1016/j.ophtha.2019.05.016. Epub 2019 May 29.
PubMed 31281056Nassisi M, Tepelus T, Corradetti G, Sadda SR. Relationship Between Choriocapillaris Flow and Scotopic Microperimetry in Early and Intermediate Age-related Macular Degeneration. Am J Ophthalmol. 2021 Feb;222:302-309. doi: 10.1016/j.ajo.2020.04.018. Epub 2020 Apr 28.
PubMed 32360341Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative approaches in multimodal fundus imaging: State of the art and future perspectives. Prog Retin Eye Res. 2023 Jan;92:101111. doi: 10.1016/j.preteyeres.2022.101111. Epub 2022 Aug 4.
PubMed 35933313Arrigo A, Aragona E, Bianco L, Antropoli A, Berni A, Saladino A, Cosi V, Bandello F, Battaglia Parodi M. The Localization of Intraretinal Cysts Has a Clinical Role on the 2-Year Outcome of Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1069-1079. doi: 10.1016/j.oret.2023.07.025. Epub 2023 Jul 30.
PubMed 37527760Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative Multimodal Imaging Characterization of Intraretinal Cysts versus Degenerative Pseudocysts in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2024 Dec;8(12):1118-1126. doi: 10.1016/j.oret.2024.05.019. Epub 2024 Jun 6.
PubMed 38848872Arrigo A, Saladino A, Aragona E, Barresi C, Mularoni C, Bandello F, Battaglia Parodi M. Clinical and Imaging Biomarkers Associated with Outer Retinal Atrophy Onset in Exudative Age-Related Macular Degeneration: A Real-Word Prospective Study. Ophthalmol Ther. 2024 May;13(5):1185-1196. doi: 10.1007/s40123-024-00903-4. Epub 2024 Mar 6.
PubMed 38446282Arrigo A, Aragona E, Del Fabbro S, Balduzzi E, Parodi MB, Bandello F. Quantitative Optical Coherence Tomography Detection of New Neovascular Branches and Association With Exudation Recurrence in Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2024 Jun 3;65(6):30. doi: 10.1167/iovs.65.6.30.
PubMed 38899961
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT07847151
- Acronym / sponsor ID
- MIND-AMD / MIND-AMD
- Conditions
- Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD), AMD Population - Intermediate or Advanced AMD, AMD and Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration
- Keywords
- Age-related macular degeneration, Multimodal retinal imaging, Mouse model, microRNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 29 Sep 2026 (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.
Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Despite the available treatments, the visual outcome is highly heterogeneous. The scientific interest is growing regarding the assessment of neuroretinal changes in AMD. Although AMD is mainly considered an outer retinal disease, recent evidence suggests a major involvement of retinal glia and neurons, i.e. an involvement of the inner retina. This damage may remarkably affect the morphological and functional AMD outcome, subverting retinal signal transmission cascade and more clearly explaining the outcome of the disease. The main goal of this study is to perform a multidisciplinary, multicenter, both prospective and retrospective evaluation of neuroretinal degeneration in different AMD stages in preclinical and clinical models.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients affected by AMD (different stages) | – | –Patients affected by intermediate, wet and dry atrophic AMD |
| Healthy controls | – | –Healthy age- and gender-matched control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by intermediate, wet and dry (geographic atrophy) age-related macular degeneration (AMD) and healthy age- and gender-matched controls
Key inclusion criteria (1 listed)
- Confirmed diagnosis of AMD
Key exclusion criteria (3 listed)
- low BCVA (<20/100)
- other ocular diseases
- uncontrolled systemic diseases potentially affecting data interpretation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuroretinal degeneration quantitative metrics
Time frame: From January 2027 to January 2030
Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
Imaging metrics of neuroretinal changes
Time frame: From January 2027 to January 2030
Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
MicroRNA profiles associated with AMD stages
Time frame: From January 2027 to January 2030
MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration.
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 29 Sep 2026.
- Background: PubMed 29721925Natoli R, Fernando N. MicroRNA as Therapeutics for Age-Related Macular Degeneration. Adv Exp Med Biol. 2018;1074:37-43. doi: 10.1007/978-3-319-75402-4_5.
- Background: PubMed 30025092Nassisi M, Fan W, Shi Y, Lei J, Borrelli E, Ip M, Sadda SR. Quantity of Intraretinal Hyperreflective Foci in Patients With Intermediate Age-Related Macular Degeneration Correlates With 1-Year Progression. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3431-3439. doi: 10.1167/iovs.18-24143.
- Background: PubMed 30794627Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
- Background: PubMed 31281056Nassisi M, Lei J, Abdelfattah NS, Karamat A, Balasubramanian S, Fan W, Uji A, Marion KM, Baker K, Huang X, Morgenthien E, Sadda SR. OCT Risk Factors for Development of Late Age-Related Macular Degeneration in the Fellow Eyes of Patients Enrolled in the HARBOR Study. Ophthalmology. 2019 Dec;126(12):1667-1674. doi: 10.1016/j.ophtha.2019.05.016. Epub 2019 May 29.
- Background: PubMed 32360341Nassisi M, Tepelus T, Corradetti G, Sadda SR. Relationship Between Choriocapillaris Flow and Scotopic Microperimetry in Early and Intermediate Age-related Macular Degeneration. Am J Ophthalmol. 2021 Feb;222:302-309. doi: 10.1016/j.ajo.2020.04.018. Epub 2020 Apr 28.
- Background: PubMed 35933313Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative approaches in multimodal fundus imaging: State of the art and future perspectives. Prog Retin Eye Res. 2023 Jan;92:101111. doi: 10.1016/j.preteyeres.2022.101111. Epub 2022 Aug 4.
- Background: PubMed 37527760Arrigo A, Aragona E, Bianco L, Antropoli A, Berni A, Saladino A, Cosi V, Bandello F, Battaglia Parodi M. The Localization of Intraretinal Cysts Has a Clinical Role on the 2-Year Outcome of Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1069-1079. doi: 10.1016/j.oret.2023.07.025. Epub 2023 Jul 30.
- Background: PubMed 38848872Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative Multimodal Imaging Characterization of Intraretinal Cysts versus Degenerative Pseudocysts in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2024 Dec;8(12):1118-1126. doi: 10.1016/j.oret.2024.05.019. Epub 2024 Jun 6.
- Background: PubMed 38446282Arrigo A, Saladino A, Aragona E, Barresi C, Mularoni C, Bandello F, Battaglia Parodi M. Clinical and Imaging Biomarkers Associated with Outer Retinal Atrophy Onset in Exudative Age-Related Macular Degeneration: A Real-Word Prospective Study. Ophthalmol Ther. 2024 May;13(5):1185-1196. doi: 10.1007/s40123-024-00903-4. Epub 2024 Mar 6.
- Background: PubMed 38899961Arrigo A, Aragona E, Del Fabbro S, Balduzzi E, Parodi MB, Bandello F. Quantitative Optical Coherence Tomography Detection of New Neovascular Branches and Association With Exudation Recurrence in Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2024 Jun 3;65(6):30. doi: 10.1167/iovs.65.6.30.
- Individual participant dataSharing planned: Yes. Scientific publications and international conferences.
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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.
Adelaide Pina, MsC contact
Alessandro Arrigo, MD, PhD principal investigator
IRCCS San Raffaele Scientific Institute, Milan, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related (Dry) Macular Degeneration and Age-Related Macular Degeneration (AMD), run by IRCCS San Raffaele.
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 1 inclusion and 3 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Alessandro Arrigo, MD, PhD (+390226433580, arrigo.alessandro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroretinal degeneration quantitative metrics (time frame: From January 2027 to January 2030). The study lists 3 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 NCT07847151, which also lists 10 linked publications.
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 29 Sep 2026.