Evidence map›Paper›PMID 41533918›Full record

Trial reportInvestigative ophthalmology & visual science2026

Exploring Trial Endpoints in Geographic Atrophy Based on Localized Functional Changes in Microperimetry and AI-Quantified OCT Biomarkers.

Klaudia Birner, Julia Mai, Daniela Boryshchuk, Florian Frommlet, Marie Louise Enzendorfer, Simon Schürer-Waldheim, Markus Gumpinger, Wolf-Dieter Vogl, Oliver Leingang, Stefan Sacu and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Investigative ophthalmology & visual science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03525613 (A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03525613 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

TypeinterventionalSponsorApellis Pharmaceuticals, Inc.Ran2018 to 2022Enrolled637ConditionsGeographic AtrophyArmsAPL-2, Sham Procedure
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Klaudia BirnerDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Julia MaiDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Daniela BoryshchukCenter for Medical Data Science, Institute of Medical Statistics, Medical University of Vienna, Vienna, Austria.
Florian FrommletCenter for Medical Data Science, Institute of Medical Statistics, Medical University of Vienna, Vienna, Austria.
Marie Louise EnzendorferDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Simon Schürer-WaldheimDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Markus GumpingerDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Wolf-Dieter VoglRetInSight, Vienna, Austria.
Oliver LeingangRetInSight, Vienna, Austria.
Stefan SacuDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Ursula Schmidt-ErfurthDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The introduction of novel therapeutics for geographic atrophy (GA) highlights the need to define functional correlates of high-risk optical coherence tomography (OCT) biomarkers, in particular retinal-pigment-epithelium (RPE) loss and ellipsoid zone (EZ) loss. We conducted a pointwise structure/function correlation between OCT-based markers and retinal sensitivity (RS) in microperimetry (MP) in GA. Methods: Patients from the phase III OAKS clinical trial (NCT03525613) examined by OCT (Heidelberg Spectralis) and Macular Integrity Assessment (MAIA, iCare, and Centervue) MP in a 68-point grid were analyzed. Deep-learning-(DL)-based algorithms quantified RPE, EZ loss, and EZ thickness from OCT. Co-registration between MP and OCT was established between each MP stimulus and OCT B-scan location. A multivariable mixed effect model was implemented to identify RS for each OCT biomarker, accounting for eccentricity. Results: Six hundred seventy-eight study and fellow eyes of 406 patients with 41,925 MP points were included. Mean RS was 17 ± 7 decibel (dB), 9 ± 7 dB, and 2 ± 6 dB in intact retina, EZ, and RPE loss, respectively. Increased EZ thickness improved RS by 0.2 dB/µm (95% confidence interval [CI] = 0.2 to 0.2, P < 0.001). In areas of EZ loss, RS was significantly reduced compared to intact retina (-8 dB, 95% CI = -9 to -8]), whereas RPE loss decreased RS by -14 dB (95% CI = -15 to -14), accounting for eccentricity (all P < 0.001). Conclusions: A significant association between RS in MP and EZ and RPE loss on OCT was established using DL. A reliable quantitative structure/function association provides the base for developing functional endpoints in clinical care and approval of novel therapeutics for GA.

Indexed as

Geographic AtrophyRetinal Pigment EpitheliumTomography, Optical CoherenceVisual FieldsVisual Field TestsAgedBiomarkersDeep LearningFemaleHumansMaleMiddle AgedRetinaVisual AcuityBiomarkers

Identifiers

PMID41533918
PMCPMC12805968

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.