Evidence map›Paper›PMID 40388106›Full record

ArticleOphthalmology and therapy2025

Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials.

Srinivas Sadda, Kensington A Hatcher, Birva K Shah, Srinivas Sai Kondapalli, Chao Li, Caroline R Baumal

2 registry-linked trialsAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03525600 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 2022Enrolled621ConditionsGeographic AtrophyArmsAPL-2, Sham Procedure
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

2 citing papers in PubMed.

  1. Article
  2. Review
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

6 authors.

Srinivas SaddaDoheny Eye Center, University of California Los Angeles, 625 S. Fair Oaks Ave; Suite 280, Pasadena, CA, 91105, USA. ssadda@doheny.org.ORCID http://orcid.org/0000-0002-4939-3306
Kensington A HatcherApellis Pharmaceuticals, Waltham, MA, USA.
Birva K ShahApellis Pharmaceuticals, Waltham, MA, USA.
Srinivas Sai KondapalliEverett and Hurite Ophthalmic Association, Pittsburgh, PA, USA.
Chao LiApellis Pharmaceuticals, Waltham, MA, USA.
Caroline R BaumalApellis Pharmaceuticals, Waltham, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRetrospective, longitudinal analysis of sham observed eyes from the phase 3 OAKS and DERBY trials evaluated the relationship between geographic atrophy (GA) growth and the presence or absence of outer retinal tubulation (ORT).

methodsPrevalence rates of ORT were calculated, and analysis of GA growth was performed using fundus autofluorescence and optical coherence tomography (OCT).

resultsORT prevalence rates were 32%, 37.5%, and 43% at baseline, month 12, and month 24, respectively. Eyes with a fully formed ORT at baseline had 23.6% less GA area growth over 24 months compared with GA without ORT present at baseline.

conclusionThe presence of ORT at baseline on OCT may be reflective of slower growth of GA, irrespective of GA location, as was noted in this series. The potential diagnostic impact of ORT should be considered when designing clinical studies for GA and when analyzing the results of such studies.

trial registrationOAKS: ClinicalTrials.gov identifier NCT03525613 (registered May 15, 2018); EudraCT identifier 2018-001435-52 (registered September 27, 2018). DERBY: ClinicalTrials.gov identifier NCT03525600 (registered May 15, 2018); EudraCT identifier 2018-001436-22 (registered September 21, 2018).

Indexed as

BiomarkerGeographic atrophyLate age-related macular degenerationOptical coherence tomographyOuter retinal tubulation

Identifiers

PMID40388106
PMCPMC12167419

What OpenQuestion holds

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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.