Evaluating the Relationship Between Function and Structure Using Data From a GA Natural History Cohort

NCT07424235 | Completed

• 1 other identifier: ARCHERY
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

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); Age Related Macular Degeneration (AMD)

Keywords

geographic atrophy; age-related macular degeneration; fundus autofluorescence; optical coherence tomography; structure-function correlations

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Related Publications (3)

• 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.

  RESULT

• 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: 26545317 RESULT

• 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.

  PMID: 29110945 RESULT

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share