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

Humans Geographic Atrophy / drug therapy Prospective Studies Visual Acuity Macular Degeneration / complications Intravitreal Injections Fluorescein Angiography

Journal

Eye (London, England)
ISSN: 1476-5454
Titre abrégé: Eye (Lond)
Pays: England
ID NLM: 8703986

Informations de publication

Date de publication:
Dec 2023
Historique:
received: 11 01 2023
accepted: 07 03 2023
revised: 24 02 2023
medline: 27 11 2023
pubmed: 26 3 2023
entrez: 25 3 2023
Statut: ppublish

Résumé

To 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. This 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. Compared 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%). Over 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.

Sections du résumé

BACKGROUND/OBJECTIVES OBJECTIVE
To 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/METHODS METHODS
This 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.
RESULTS RESULTS
Compared 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%).
CONCLUSIONS CONCLUSIONS
Over 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.

Identifiants

DOI: 10.1038/s41433-023-02497-w PMID: 36964259 PMC: PMC10686386
pubmed: 36964259
doi: 10.1038/s41433-023-02497-w
pii: 10.1038/s41433-023-02497-w
pmc: PMC10686386
doi:

Types de publication

Randomized Controlled Trial Clinical Trial, Phase II Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

3551-3557

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2023. The Author(s).

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Auteurs

Sunil S Patel (SS)

West Texas Retina Consultants, Abilene, TX, USA.

David R Lally (DR)

New England Retina Consultants, Springfield, MA, USA.

Jason Hsu (J)

The Retina Service of Wills Eye Hospital, Wills Eye Physicians-Mid Atlantic Retina, Philadelphia, PA, USA.

Charles C Wykoff (CC)

Retina Consultants of Texas, Houston, TX, USA.

David Eichenbaum (D)

Retina Vitreous Associates of Florida, St. Petersburg, FL, USA.
Morsani College of Medicine at The University of South Florida, Tampa, FL, USA.

Jeffrey S Heier (JS)

Ophthalmic Consultants of Boston, Boston, MA, USA.

Glenn J Jaffe (GJ)

Department of Ophthalmology, Duke University, Durham, NC, USA.

Keith Westby (K)

IVERIC Bio, Inc, New York, NY, USA.

Dhaval Desai (D)

IVERIC Bio, Inc, New York, NY, USA.

Liansheng Zhu (L)

IVERIC Bio, Inc, New York, NY, USA.

Arshad M Khanani (AM)

Sierra Eye Associates and The University of Nevada, Reno School of Medicine, Reno, NV, USA. arshad.khanani@gmail.com.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Maladies de l'oeil › Rétinopathies › Dégénérescence de la rétine › Dégénérescence maculaire › Atrophie géographique › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Phénomènes physiologiques oculaires › Acuité visuelle › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Maladies de l'oeil › Rétinopathies › Dégénérescence de la rétine › Dégénérescence maculaire › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Injections › Injections oculaires › Injections intravitréennes › Avacincaptad pegol for geographic atrophy...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Techniques de diagnostic ophtalmologique › Angiographie fluorescéinique › Avacincaptad pegol for geographic atrophy...