This study will evaluate the long-term safety and tolerability of IVT faricimab in patients with nAMD who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics,…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to evaluate the long-term ocular and systemic safety
and tolerability of faricimab in all patients who have enrolled in the
long-term extension (LTE) study who have received at least one injection of
faricimab during the LTE, regardless of adherence to treatment or to the
protocol, on the basis of the following endpoints:
- Incidence and severity of ocular adverse events
- Incidence and severity of non-ocular adverse events.
Secondary outcome
The exploratory efficacy objective of this study is to assess the long-term
efficacy of IVT faricimab for the management of nAMD in all patients who have
enrolled in the LTE study who have received at least one injection of faricimab
during the LTE
See section 2 of the protocol for all exploratory, pharmacokinetic,
immunogenicity and biomarker objectives
Background summary
Neovascular age-related macular degeneration (nAMD) (also known as wet AMD) is
a form of advanced AMD that causes rapid and severe visual loss and remains a
leading cause of visual impairment in the elderly. The Sponsor is currently
investigating the efficacy and safety of faricimab 6 mg in nAMD in two
identical, global, Phase III, randomized, double-masked, active
comparator-controlled trials. Approximately 1280 patients have been randomized
in a 1:1 ratio to one of two treatment arms. The aim of the Phase III program
is to evaluate the efficacy, safety, durability, and
pharmacokinetics of the 6-mg dose of faricimab administered at up to 16-week
intervals compared with aflibercept monotherapy Q8W in patients with nAMD. See
protocol section 1.2
Study objective
This study will evaluate the long-term safety and tolerability of IVT faricimab
in patients with nAMD who have completed either of the Phase III (GR40306 or
GR40844) studies. Additional assessments relating to efficacy,
pharmacokinetics, immunogenicity, and biomarkers will be performed.
Study design
Approximately 1280 patients are expected to participate in this extension study
after completion of the parent studies, and will follow a single faricimab 6 mg
PTI regimen. In this extension study, the study eye will be the same as that
randomized in the parent studies, GR40306 and GR40844.
Patients will be required to attend monthly study assessment visits between Day
1 and Week 12 (the masked period of the study) in order to preserve masking of
a patient*s treatment assignment in the parent study. From Week 16 until
approximately Week 104, patients will attend study visits at intervals as
scheduled by the IxRS system based on the PTI algorithm. A final Safety
Follow-Up visit will take place at least 28 days after the final faricimab
treatment visit (see Figure 1).
Intervention
Patients taking part in the study will be treated with sham or faricimab in the
blind phase (12 weeks) every 4 weeks. Thereafter every 8-16 weeks with
faricimab.
Study burden and risks
First 3 months patients need to come to the site more often than with standard
care, and also undergo a possible sham procedure to maintain the masking of the
parent study. Patients also need to undergo more scans, blood is drawn and need
to answer questionnaires. All risks are listed in the ICF.
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
Inclusion criteria
• Previous enrollment in and completion of Study GR40306 (TENAYA) or Study
GR40844 (LUCERNE), 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.
Exclusion criteria
• Pregnant or breastfeeding, or intending to become pregnant during the study
or within 28 days 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-004523-16-NL |
| ClinicalTrials.gov | NCT04777201 |
| CCMO | NL76733.056.21 |