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

NCT07847151 — Not yet recruiting, 160 participants, IRCCS San Raffaele

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RegistryNCT07847151, acronym MIND-AMD
StatusNot yet recruiting
Study typeObservational
Enrollment160 (Estimated)
SponsorIRCCS San Raffaele (Other); collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ConditionsAge-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
Datesstart 2027-01-02 (estimated), primary completion 2029-06-30 (estimated), completion 2030-01-02 (estimated), first posted 2026-09-29, last updated 2026-09-29

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-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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+Arms and interventions

ArmTypeInterventionsDescription
Patients affected by AMD (different stages)Patients affected by intermediate, wet and dry atrophic AMD
Healthy controlsHealthy age- and gender-matched control

+Outcome measures

Primary outcomes

  • Neuroretinal degeneration quantitative metrics [From January 2027 to January 2030]: Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
  • Imaging metrics of neuroretinal changes [From January 2027 to January 2030]: Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration
  • MicroRNA profiles associated with AMD stages [From January 2027 to January 2030]: MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration.

+Eligibility

Sex: All, ages: 50 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Confirmed diagnosis of AMD

Exclusion Criteria:

* low BCVA (<20/100)
* other ocular diseases
* uncontrolled systemic diseases potentially affecting data interpretation

+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 38899961

+Investigators

My Notes