EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States (ICTRP)

Identifiant de l'essai ICTRP
NCT04777201 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (BASEC)

Titre académique
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X) (ICTRP)

Titre public
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (ICTRP)

Maladie en cours d'investigation
Neovascular Age-related Macular Degeneration (ICTRP)

Intervention étudiée
Drug: Faricimab;Other: Sham Procedure (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 50 Years
Inclusion Criteria for the Main Study:

- 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.

Inclusion Criteria for the Substudy:

- In addition to all inclusion criteria specified in the main Study GR42691,
participants in the Substudy must meet the following criteria:

- 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

Exclusion Criteria for the Main Study:

- 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

Exclusion Criteria for the Substudy:

In addition to the exclusion criteria specified in the main Study GR42691, patients will
be excluded from this substudy if they meet any of the following exclusion criteria:

- Prior and/or current administration of faricimab in the fellow (non-study) eye

- Prior administration of brolucizumab in the fellow (non-study) eye

Exclusion Criteria in Either Eye for the Substudy:

- 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 (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Main Study: Incidence and Severity of Ocular Adverse Events;Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events;Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye (ICTRP)

Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Clinical Trials, Hoffmann-La Roche (ICTRP)

ID secondaires
2020-004523-16, GR42691 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04777201 (ICTRP)