Evidence map›Paper›PMID 36964259›Full record

Trial reportEye (London, England)2023

Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial.

Sunil S Patel, David R Lally, Jason Hsu, Charles C Wykoff, David Eichenbaum, Jeffrey S Heier, Glenn J Jaffe, Keith Westby, Dhaval Desai, Liansheng Zhu and 1 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
34.8field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 1 synthesis or guideline pooled it, 125 citations in OpenAlex.

  1. Pooled it
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  3. Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
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  6. Observational
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Sunil S PatelWest Texas Retina Consultants, Abilene, TX, USA.
David R LallyNew England Retina Consultants, Springfield, MA, USA.
Jason HsuThe Retina Service of Wills Eye Hospital, Wills Eye Physicians-Mid Atlantic Retina, Philadelphia, PA, USA.
Charles C WykoffRetina Consultants of Texas, Houston, TX, USA.
David EichenbaumRetina Vitreous Associates of Florida, St. Petersburg, FL, USA.
Jeffrey S HeierOphthalmic Consultants of Boston, Boston, MA, USA.
Glenn J JaffeDepartment of Ophthalmology, Duke University, Durham, NC, USA.
Keith WestbyIVERIC Bio, Inc, New York, NY, USA.
Dhaval DesaiIVERIC Bio, Inc, New York, NY, USA.
Liansheng ZhuIVERIC Bio, Inc, New York, NY, USA.
Arshad M KhananiSierra Eye Associates and The University of Nevada, Reno School of Medicine, Reno, NV, USA. arshad.khanani@gmail.com.
Duke University · USNew England Retina Associates · USOphthalmic Consultants of Boston · USRetina Consultants of Houston · USUniversity of Nevada, Reno · USUniversity of South Florida · USWest Texas Retina Consultants · USWills Eye Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesTo assess the safety and efficacy of avacincaptad pegol (ACP), a C5 inhibitor, for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) over an 18-month treatment course. SUBJECTS/

methodsThis study was an international, prospective, randomized, double-masked, sham-controlled, phase 2/3 clinical trial that consisted of 2 parts. In part 1, 77 participants were randomized 1:1:1 to receive monthly intravitreal injections of ACP 1 mg, ACP 2 mg, or sham. In part 2, 209 participants were randomized 1:2:2 to receive monthly ACP 2 mg, ACP 4 mg, or sham. The mean rate of change of GA over 18 months was measured by fundus autofluorescence.

resultsCompared with their respective sham cohorts, monthly ACP treatment reduced the mean GA growth (square root transformation) over 18 months by 28.1% (0.168 mm, 95% CI [0.066, 0.271]) for the 2 mg cohort and 30.0% (0.167 mm, 95% CI [0.062, 0.273]) for the 4 mg cohort. ACP treatment was generally well tolerated over 18 months, with most ocular adverse events (AEs) related to the injection procedure. Macular neovascularization (MNV) was more frequent in both 2 mg (11.9%) and 4 mg (15.7%) cohorts than their respective sham control groups (2.7% and 2.4%).

conclusionsOver this 18-month study, ACP 2 mg and 4 mg showed continued reductions in the progression of GA growth compared to sham and continued to be generally well tolerated. A pivotal phase 3 GATHER2 trial is currently underway to support the efficacy and safety of ACP as a potential treatment for GA.

Indexed as

Geographic AtrophyMacular DegenerationFluorescein AngiographyHumansIntravitreal InjectionsProspective StudiesVisual Acuity

Identifiers

PMID36964259
PMCPMC10686386
OpenAlexW4360871148

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Registered trials

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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.