Resumen

Este estudio de extensión a largo plazo está diseñado para evaluar la seguridad y tolerabilidad a largo plazo de faricimab 6 miligramos (mg) administrado mediante inyección intravítrea a un intervalo de tratamiento personalizado (ITP) en participantes con degeneración macular relacionada con la edad neovascular (DMARn) que se inscribieron y completaron uno de los estudios de Fase III: GR40306 (NCT03823287) o GR40844 (NCT03823300), también denominados estudios parentales. Los pacientes elegibles que consientan participar en este estudio principal serán incluidos al completar la visita de fin de estudio en el estudio parental. Adicionalmente, se está llevando a cabo un subestudio cuyo objetivo es evaluar el impacto de faricimab intravítreo en la salud de las células endoteliales corneales en los ojos de estudio de los pacientes con DMARn, con el fin de cumplir un requisito de farmacovigilancia poscomercialización de la Administración de Alimentos y Medicamentos de los EE. UU. (FDA). Los ojos contralaterales de los mismos participantes incluidos en el subestudio servirán como controles.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.
Sign an informed consent form for the Substudy
Must be able to participate for at least 48 weeks in the Substudy and have at least the first visit while enrolled in the main Study GR42691
A difference of \<10% in corneal endothelial cell density at screening between the two eyes as measured by specular microscopy and determined by the independent reading center

Criterios de exclusión

Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study-related procedure preparations, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Prior and/or current administration of faricimab in the fellow (non-study) eye
Prior administration of brolucizumab in the fellow (non-study) eye
Corneal endothelial cell density ≤1500 cells/mm2 in either eye at screening as determined by the independent corneal reading center
Fuchs endothelial corneal dystrophy Grade ≥2
Previous ocular trauma (blunt or penetrating) and/or corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.)
Any ocular condition that precludes obtaining an analyzable specular microscopy image
Active or history of corneal edema
Any active or history of corneal dystrophies, excluding Fuchs endothelial corneal dystrophy Grade \<2
Active or history of iridocorneal endothelial syndrome
Active or history of pseudoexfoliation syndrome
Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)
Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
Prior pars plana vitrectomy surgery
Previous intraocular device implantation excluding intraocular lenses
Cataract surgery within 6 months of screening or planned for during the study
History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery. Other types of prior glaucoma surgery are allowed providing that the surgery occur more than 6 months before screening
Administration of topical Rho kinase inhibitors (e.g., Rhopressa eye drops) within 1 month prior to the screening visit
Contact lens wear in either eye within 2 months of screening
History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty)
Active or history of iridocorneal endothelial syndrome
Active or history of pseudoexfoliation syndrome

Intervenciones

drug

Faricimab

Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

other

Sham Procedure

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.

drug

Anti-VEGF Therapy

At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

Fundacion Zambrano

CABA, Argentina

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, Argentina

Oftalmos

Capital Federal, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Oftar

Mendoza, Argentina

Grupo Laser Vision

Rosario, Argentina

Estudio de extensión abierto y multicéntrico para evaluar la seguridad y tolerabilidad a largo plazo de faricimab en pacientes con degeneración macular relacionada con la edad neovascular (AVONELLE-X)