Diabetic Macular Edema
Conditions
Brief summary
This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.
Interventions
DRUGFaricimab
Participants will receive 6-milligram (mg) faricimab intravitreal (IVT) injections, as described in the study arm descriptions for each study phase.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a multicenter, open-label, single-arm study with two phases: the main study phase for all eligible patients (up to 56 weeks), followed by an optional long-term extension phase for eligible patients only in the U.S. (up to 100 weeks).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Phase General Inclusion Criteria: * Self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; or self-identify as Asian Indian residents of the Indian subcontinent * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) and/or oral anti-hyperglycemic agents for the treatment of diabetes * Hemoglobin A1c (HbA1c) ≤10% (Note: up to 20% of participants enrolled may have HbA1c up to 12%) * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception methods as defined in the protocol Main Phase Ocular Inclusion Criteria for Study Eye: * Intravitreal (IVT) treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye) * Diabetic macular edema, defined as macular thickening by SD-OCT involving the center of the macula * BCVA letter score of 73 to 20 letters (both inclusive) using the ETDRS protocol at the initial testing distance of 4 meters at the baseline visit (Day 1) * Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis Long-Term Extension (LTE) Inclusion Criteria: * Enrollment in and completion of the main study, without discontinuation from study or study drug treatment * Signed LTE-phase 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 contraception methods as defined in the protocol
Exclusion criteria
Main Phase General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-Term Extension Phase: Incidence and Severity of Non-Ocular Adverse Events | From Day 1 until end of long-term extension (up to 100 weeks) |
| Long-Term Extension Phase: Incidence and Severity of Ocular Adverse Events | From Day 1 until end of long-term extension (up to 100 weeks) |
| Main Phase: Change in Best Corrected Visual Acuity (BCVA) from Baseline at Week 56, as Measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters | From Baseline to Week 56 |
Secondary
| Measure | Time frame |
|---|---|
| Main Phase: Change from Baseline in Central Subfield Thickness Over Time | Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56 |
| Main Phase: Percentage of Participants Gaining ≥15 or ≥10 Letters in BCVA from Baseline at Week 56 | Baseline and Week 56 |
| Main Phase: Percentage of Participants Avoiding a Loss of ≥15 or ≥10 Letters in BCVA from Baseline at Week 56 | Baseline and Week 56 |
| Main Phase: Percentage of Participants with a ≥3-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time | Baseline and Weeks 20 and 56 |
| Main Phase: Incidence and Severity of Non-Ocular Adverse Events | From Baseline up to Week 56 |
| Main Phase: Number of Participants Testing Positive for Anti-Drug Antibodies (ADAs) Against Faricimab at Baseline and Anytime During the Study | From Baseline up to Week 56 |
| Main Phase: Percentage of Participants with a Greater Than or Equal to (≥)2-Step ETDRS Diabetic Retinopathy Severity Scale (DRSS) Improvement from Baseline Over Time | Baseline and Weeks 20 and 56 |
| Main Phase: Incidence and Severity of Ocular Adverse Events | From Baseline up to Week 56 |
| Main Phase: Percentage of Participants with Absence of Intraretinal Fluid Over Time | Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56 |
| Main Phase: Percentage of Participants with Absence of Subretinal Fluid Over Time | Baseline and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 48, 52, and 56 |
Countries
India, Kenya, Puerto Rico, United States
Contacts
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed