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Not yet recruitingNCT07847151MIND-AMDUpdated Sep 29, 2026

MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.

An observational study in Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD) and AMD Population - Intermediate or Advanced AMD, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
50 Years and older
Sex
All
01

Study 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). 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.

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Conditions studied

  • 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
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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients affected by intermediate, wet and dry (geographic atrophy) age-related macular degeneration (AMD) and healthy age- and gender-matched controls

Inclusion criteria

  • Confirmed diagnosis of AMD

Exclusion criteria

Exclusion Criteria:

  • low BCVA (\<20/100)
  • other ocular diseases
  • uncontrolled systemic diseases potentially affecting data interpretation
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients affected by AMD (different stages)

    Patients affected by intermediate, wet and dry atrophic AMD

  • Healthy controls

    Healthy age- and gender-matched control

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What researchers measure

Primary outcomes

  1. Neuroretinal degeneration quantitative metrics

    Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration

    Time frame: From January 2027 to January 2030

  2. Imaging metrics of neuroretinal changes

    Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration

    Time frame: From January 2027 to January 2030

  3. MicroRNA profiles associated with AMD stages

    MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration.

    Time frame: From January 2027 to January 2030

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Study locations

No study locations are listed for this record.

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References and documents

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 29721925 ↗
  • Nassisi 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 30025092 ↗
  • Nassisi 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 30794627 ↗
  • Nassisi 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 31281056 ↗
  • Nassisi 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 32360341 ↗
  • Arrigo 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 35933313 ↗
  • Arrigo 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 37527760 ↗
  • Arrigo 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 38848872 ↗
  • Arrigo 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 38446282 ↗
  • Arrigo 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 ↗

Individual participant data

Plan to share: Yes — Scientific publications and international conferences.

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Registry details

Key details

Study ID
NCT07847151
Lead sponsor
IRCCS San Raffaele
Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Alessandro Arrigo (MD, PhD, Head of Imaging Unit, Ophthalmology Department, IRCCS San Raffaele) — Principal investigator
First posted
Sep 29, 2026
Start date
Jan 2, 2027 (estimated)
Primary completion
Jun 30, 2029 (estimated)
Completion
Jan 2, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Alessandro Arrigo, MD, PhD
Contact
arrigo.alessandro@hsr.it
+390226433580
Adelaide Pina, MsC
Contact
pina.adelaide@hsr.it
Alessandro Arrigo, MD, PhD
principal investigator · IRCCS San Raffaele Scientific Institute, Milan, Italy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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