Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 6:03 PM
Study NCT ID:
NCT07424235
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Relationship Between Function and Structure in ARCHER II-like Population Using Data From a Natural History Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters', 'timeFrame': 'From baseline to the last available follow-up visit, with a minimum follow-up of 6 months and a preferred follow-up of 12 to 15 months.', 'description': 'Proportion of eyes experiencing a loss of at least 15 ETDRS letters from baseline best-corrected visual acuity. Visual acuity is measured using the ETDRS methodology under normal luminance conditions, based on clinical data collected during routine care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['geographic atrophy', 'age-related macular degeneration', 'fundus autofluorescence', 'optical coherence tomography', 'structure-function correlations'], 'conditions': ['Age Related Macular Degeneration (AMD)', 'Age Related Macular Degeneration', 'AMD', 'Geographic Atrophy', 'Geographic Atrophy Secondary to Age-related Macular Degeneration', 'Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD)']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'David S Boyer; Protection Against Vision Loss by ANX007: Results from the Phase 2 ARCHER Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2024;65(7):2791.'}, {'pmid': '26545317', 'type': 'RESULT', 'citation': 'Schmitz-Valckenberg S, Sahel JA, Danis R, Fleckenstein M, Jaffe GJ, Wolf S, Pruente C, Holz FG. Natural History of Geographic Atrophy Progression Secondary to Age-Related Macular Degeneration (Geographic Atrophy Progression Study). Ophthalmology. 2016 Feb;123(2):361-368. doi: 10.1016/j.ophtha.2015.09.036. Epub 2015 Nov 3.'}, {'pmid': '29110945', 'type': 'RESULT', 'citation': 'Fleckenstein M, Mitchell P, Freund KB, Sadda S, Holz FG, Brittain C, Henry EC, Ferrara D. The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmology. 2018 Mar;125(3):369-390. doi: 10.1016/j.ophtha.2017.08.038. Epub 2017 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration that leads to progressive and irreversible vision loss. The course of visual decline varies widely among patients, and it is not always clear which anatomical features of the retina are associated with faster loss of vision.\n\nThis retrospective observational study aims to describe the natural history of vision loss in patients with geographic atrophy who have characteristics similar to those enrolled in the ARCHER II clinical trial. The study will analyze previously collected clinical and imaging data from patients followed during routine clinical care at a single center.\n\nThe main goal of the study is to evaluate the relationship between changes in visual function and retinal anatomical features, such as the size and location of atrophic lesions and retinal layer integrity, using fundus autofluorescence and optical coherence tomography images.\n\nNo treatments or study procedures are performed as part of this research. All data used in the study were collected during standard clinical practice and analyzed retrospectively.', 'detailedDescription': 'This is a monocentric, retrospective observational study designed to evaluate the relationship between visual function and retinal anatomical features in an ARCHER II-like population with geographic atrophy (GA) secondary to dry age-related macular degeneration.\n\nThe study will analyze a natural history cohort identified from previously collected clinical and imaging data obtained during routine care at IRCCS Ospedale San Raffaele. Eligible eyes meet predefined inclusion and exclusion criteria consistent with those used in the ARCHER II trial, including well-demarcated GA lesions, preserved baseline visual acuity, and the absence of choroidal neovascularization or prior intravitreal treatment.\n\nThe primary objective is to estimate the proportion of eyes experiencing a loss of at least 15 ETDRS letters from baseline and to characterize the trajectory of visual acuity decline over time. Secondary objectives include the identification of baseline anatomical features associated with the risk and timing of significant visual loss, such as GA lesion size, foveal involvement, fundus autofluorescence patterns, lesion focality, and outer retinal layer thickness measured on optical coherence tomography.\n\nExploratory analyses will investigate the relationship between visual function decline and ellipsoid zone integrity metrics, where available, and will apply multivariable and machine learning-based models to explore non-linear associations between anatomical and functional parameters.\n\nAs this is a retrospective study, no investigational medicinal products, devices, or study-specific interventions are involved. All analyses are performed on pseudonymized or anonymized data derived from existing medical records and imaging archives. No additional patient contact, visits, or procedures are required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients aged 50 years or older with geographic atrophy secondary to dry age-related macular degeneration, identified retrospectively from a single tertiary referral center. The analysis includes eyes meeting predefined anatomical and functional criteria similar to those used in the ARCHER II clinical trial, based on clinical records and retinal imaging collected during routine care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 50 years or older at baseline.\n* Diagnosis of geographic atrophy secondary to dry age-related macular degeneration in the study eye.\n* Well-demarcated geographic atrophy lesions confirmed by fundus autofluorescence imaging, with a total lesion area between 2.5 mm² and 17.5 mm².\n* Presence of hyperautofluorescence in the junctional zone of the geographic atrophy lesion.\n* Best-corrected visual acuity between 45 and 83 ETDRS letters at baseline.\n* Availability of longitudinal clinical and imaging data with at least 6 months of follow-up.\n\nExclusion Criteria:\n\n* Evidence or history of neovascular (wet) age-related macular degeneration in the study eye.\n* Prior intravitreal therapy or systemic treatments specifically targeting age-related macular degeneration.\n* Geographic atrophy lesions contiguous with peripapillary atrophy.\n* Coexisting ocular diseases that could independently affect visual acuity or retinal structure.\n* Incomplete or poor-quality clinical or imaging data precluding reliable assessment of study outcomes.'}, 'identificationModule': {'nctId': 'NCT07424235', 'acronym': 'ARCHERY', 'briefTitle': 'Evaluating the Relationship Between Function and Structure in ARCHER II-like Population Using Data From a Natural History Cohort', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Ospedale San Raffaele'}, 'officialTitle': 'Anatomical and Retinal CHanges Evaluated in Real-life GeographY Atrophy', 'orgStudyIdInfo': {'id': 'ARCHERY'}, 'secondaryIdInfos': [{'id': 'Annexon PO 8716', 'type': 'OTHER_GRANT', 'domain': 'Annexon, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Ospedale San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Annexon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Vittoria Cicinelli', 'investigatorAffiliation': 'IRCCS Ospedale San Raffaele'}}}}