Evidence map›Paper›PMID 39538001›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025

Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial.

Giulia Corradetti, Ayesha Karamat, Sowmya Srinivas, Sophiana Lindenberg, Swetha B Velaga, Federico Corvi, Yamini Attiku, Muneeswar Gupta Nittala, Dhaval Desai, Liansheng Zhu and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02686658 (A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02686658 phase2 / phase3completednot on this map

A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

TypeinterventionalSponsorIVERIC bio, Inc.Ran2015 to 2020Enrolled286ConditionsGeographic Atrophy, Dry Age-Related Macular DegenerationArmsAvacincaptad Pegol, Sham
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Geographic atrophy: Understanding the relationship between structure and function.Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)
    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

12 authors.

Giulia CorradettiDepartment of Ophthalmology, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA, USA.
Ayesha KaramatDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Sowmya SrinivasDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Sophiana LindenbergDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Swetha B VelagaDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Federico CorviDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Yamini AttikuDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Muneeswar Gupta NittalaDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA.
Dhaval DesaiFormerly Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
Liansheng ZhuFormerly Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
Dina AbulonAstellas Pharma US, Northbrook, IL, USA.
SriniVas R SaddaDoheny Image Reading and Research Lab, Doheny Eye Institute, 150 N. Orange Grove Blvd, Pasadena, CA, 91103, USA. ssadda@doheny.org.ORCID http://orcid.org/0000-0002-4939-3306

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDetermine rates of progression of incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) to complete retinal pigment epithelium and outer retinal atrophy (cRORA) and rates of progression of drusen to iRORA/cRORA in eyes with geographic atrophy (GA) treated with avacincaptad pegol (ACP).

methodsPost hoc analysis of the GATHER1 prospective, randomized, double-masked Phase II/III study that evaluated ACP 2 mg vs. sham. Optical coherence tomography (OCT) data from GATHER1 were transferred to the Doheny Image Reading and Research Lab for masked analysis by readers experienced with Classification of Atrophy Meeting (CAM) grading features. Regions of OCT volume scans more than 500 µm from the border of GA lesions were evaluated at baseline and at months 6, 12, and 18. Participants with iRORA and/or drusen (≥ 40 µm height on OCT) at baseline were included in the analysis.

resultsThe proportion of eyes progressing from iRORA to cRORA in the ACP 2 mg group was 5.0%, 15.0%, and 20.0% at months 6, 12, and 18 respectively, as compared with 11.8%, 30.2%, and 41.8% of eyes in the sham group. The proportion of ACP 2 mg-treated eyes progressing from drusen to iRORA or cRORA was 3.8%, 7.6%, and 7.6% at months 6, 12, and 18 compared with 15.9%, 18.1%, and 27.2% of sham-treated eyes.

conclusionsRates of progression from iRORA to cRORA and drusen to iRORA/cRORA were reduced in eyes treated with ACP 2 mg vs. sham, with increasing separation between groups over time, suggesting early intervention may slow disease progression.

trial registrationClinicalTrials.gov identifier: NCT02686658. Date of registration: February 16, 2016. KEY MESSAGES: What is known Geographic atrophy is an advanced form of age-related macular degeneration (AMD) that leads to irreversible vision loss, presenting a significant public health unmet need. The Classification of Atrophy Meeting (CAM) group recommended a new nomenclature for advanced AMD lesions, based on the affected anatomical layers on optical coherence tomography. Accordingly, the terms incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) were introduced (Guymer et al., Ophthalmology 127:394-409, 2020; Sadda et al., Ophthalmology 125:537-548, 2018). What is new GATHER1 post hoc analysis shows that treatment with avacincaptad pegol (ACP) 2 mg decreases the proportion of eyes that progress from iRORA to cRORA, and from drusen to iRORA or cRORA, compared with sham, over 6, 12, and 18 months. These findings suggest a potential role for ACP in delaying the progression of existing pre-atrophic AMD lesions.

Indexed as

Geographic AtrophyRetinal Pigment EpitheliumTomography, Optical CoherenceVisual AcuityAgedAtrophyDisease ProgressionDouble-Blind MethodFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsMaleMiddle AgedAge-related macular degenerationAvacincaptad pegolDrusenGeographic atrophy

Identifiers

PMID39538001
PMCPMC11953152

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.