None listed
Conditions
Interventions
Eligible patients who choose to enroll into the LTE study will have monthly, masked, study visits for the first 4 months of the study (Day 1 through to Week 16
see Figure 1). During the masked period, patients and physicians will only be masked to the faricimab treatment interval.
Following the masked period, the study will follow an open-label design in
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Previous enrollment in and completion of Study GR40349 (YOSEMITE) or GR40398 (RHINE), without study or study drug discontinuation. • Signed Informed Consent Form • Ability to comply with the study protocol, in the investigator´s judgment • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the final dose of study treatment A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization; hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. Contraception methods that do not result in a failure rate of < 1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. If a patient is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements of the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: • Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final ITV injection of faricimab Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. • 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 treatment procedure, 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:By Physicians follow-up Measure:Incidence and severity of ocular adverse events Timepoints:Throughout the study ; Outcome name:By Physicians follow-up Measure:Incidence and severity of systemic (non-ocular) adverse events Timepoints:Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:By their Diabetic Retinopathy Severity Scale (DRSS) score and Physicians follow-up. Measure:Proportion of patients with presence of central retina intraretinal fluid, subretinal fluid, and both. Proportion of patients with a ≥2- o ≥ 3- step improvement/ worsening. Proportion of patients who develop new (Proliferative Diabetic Retinopathy). Timepoints:From the parent study Day 1 and the LTE study Day 1 visit ; Outcome name:Using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart Measure:Change in BCVA (best-corrected visual acuity) Timepoints:From the parent study Day 1 and the LTE study Day 1 visit ; Outcome name:Measured by SD-OCT Measure:Change in central subfield thickness Timepoints:From the parent study Day 1 and the LTE study Day 1 visit ; Outcome name:Counting of the number of injections received Measure:Number of faricimab injections received Timepoints:during the LTE study ; Outcome name:Assessed using the National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) composite score, the near activity subscale score, the distance activities subscale score, and driving subscale score Measure:Change in patient-reported vision-related functioning and quality of life Timepoints:From the parent study Day 1 and the LTE study Day 1 visit | — |
Countries
Argentina, Australia, Canada, Hong Kong, Korea South, United States
Contacts
Public ContactCinthya Barrantes
ROCHE FARMA (PERU) S.A.
Outcome results
None listed