Age Related Macular Degeneration (AMD)ARCHERYNCT07424235
Evaluating the Relationship Between Function and Structure Using Data From a GA Natural History Cohort
An observational study of Age Related Macular Degeneration (AMD) and Age Related Macular Degeneration, run by IRCCS Ospedale San Raffaele.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration (AMD), Age Related Macular Degeneration, AMD
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: 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 recent clinical trials, based on clinical records and retinal imaging collected during routine care.
Who may be able to join
- Male or female patients aged 50 years or older at baseline.
- Diagnosis of geographic atrophy secondary to dry age-related macular degeneration in the study eye.
- Well-demarcated geographic atrophy lesions confirmed by fundus autofluorescence imaging, with a total lesion area between 2.5 mm² and 17.5 mm².
- Presence of hyperautofluorescence in the junctional zone of the geographic atrophy lesion.
- Best-corrected visual acuity between 45 and 83 ETDRS letters at baseline.
- Availability of longitudinal clinical and imaging data with at least 6 months of follow-up.
Who cannot join
- Evidence or history of neovascular (wet) age-related macular degeneration in the study eye.
- Prior intravitreal therapy or systemic treatments specifically targeting age-related macular degeneration.
- Geographic atrophy lesions contiguous with peripapillary atrophy.
- Coexisting ocular diseases that could independently affect visual acuity or retinal structure.
- Incomplete or poor-quality clinical or imaging data precluding reliable assessment of study outcomes.
About this study
Official title: Anatomical and Retinal CHanges Evaluated in Real-life GeographY Atrophy
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.
This 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 recent clinical trials. The study will analyze previously collected clinical and imaging data from patients followed during routine clinical care at a single center.
Read more
The 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.
No 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.
Read the detailed description
This is a monocentric, retrospective observational study designed to evaluate the relationship between visual function and retinal anatomical features in a population with geographic atrophy (GA) secondary to dry age-related macular degeneration.
The 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 recent clinical trials, including well-demarcated GA lesions, preserved baseline visual acuity, and the absence of choroidal neovascularization or prior intravitreal treatment.
The 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.
Exploratory 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.
As 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.
- 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)
- Keywords
- geographic atrophy, age-related macular degeneration, fundus autofluorescence, optical coherence tomography, structure-function correlations
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startJan 2015
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Vittoria Cicinelli, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424235
- Sponsor's protocol ID
- ARCHERY
- Other IDs
- ARCHERY
- Acronym
- ARCHERY
- Status last verified
- May 2026
- First submitted
- 13 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 26545317Fleckenstein 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.
PubMed 29110945
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Retinal CHanges Evaluated in Real-life GeographY Atrophy
- ClinicalTrials.gov ID
- NCT07424235
- Acronym / sponsor ID
- ARCHERY / ARCHERY
- 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)
- Keywords
- geographic atrophy, age-related macular degeneration, fundus autofluorescence, optical coherence tomography, structure-function correlations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 20 Feb 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.
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.
This 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 recent clinical trials. The study will analyze previously collected clinical and imaging data from patients followed during routine clinical care at a single center.
The 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.
No 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.
Detailed description
This is a monocentric, retrospective observational study designed to evaluate the relationship between visual function and retinal anatomical features in a population with geographic atrophy (GA) secondary to dry age-related macular degeneration.
The 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 recent clinical trials, including well-demarcated GA lesions, preserved baseline visual acuity, and the absence of choroidal neovascularization or prior intravitreal treatment.
The 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.
Exploratory 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.
As 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 recent clinical trials, based on clinical records and retinal imaging collected during routine care.
Key inclusion criteria (6 listed)
- Male or female patients aged 50 years or older at baseline.
- Diagnosis of geographic atrophy secondary to dry age-related macular degeneration in the study eye.
- Well-demarcated geographic atrophy lesions confirmed by fundus autofluorescence imaging, with a total lesion area between 2.5 mm² and 17.5 mm².
- Presence of hyperautofluorescence in the junctional zone of the geographic atrophy lesion.
- Best-corrected visual acuity between 45 and 83 ETDRS letters at baseline.
Key exclusion criteria (5 listed)
- Evidence or history of neovascular (wet) age-related macular degeneration in the study eye.
- Prior intravitreal therapy or systemic treatments specifically targeting age-related macular degeneration.
- Geographic atrophy lesions contiguous with peripapillary atrophy.
- Coexisting ocular diseases that could independently affect visual acuity or retinal structure.
- Incomplete or poor-quality clinical or imaging data precluding reliable assessment of study outcomes.
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
Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Results publicationDavid S Boyer; Protection Against Vision Loss by ANX007: Results from the Phase 2 ARCHER Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2024;65(7):2791.
- Results publication: PubMed 26545317Schmitz-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.
- Results publication: PubMed 29110945Fleckenstein 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration (AMD) and Age Related Macular Degeneration, run by IRCCS Ospedale 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters (time frame: 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.). 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 NCT07424235, which also lists 3 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 11 May 2026.