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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Confirmed diagnosis of AMD

Disqualifiers

low BCVA (<20/100)

other ocular diseases

uncontrolled systemic diseases potentially affecting data interpretation

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 2 trial groups
Group A: Patients affected by AMD (different stages)
Group B: Healthy controls

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

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