None listed
Conditions
Interventions
Brazo A Type of group
Arm A (administered Q8W) (n=300): Patients randomized to Arm A will receive 6‑
mg IVT RO6867461 injections Q4W to Week 20, followed by 6‑
Brazo C Type of group
Arm C (comparator arm) (administered Q8W) (n=300): Patients randomized to Arm C will receive 2-mg IVT aflibercept injections Q4W to Week 16, followed by 2‑
mg IVT aflibercept injections Q8W to Week 96, followed by the final study visit at Week 100.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following general inclusion criteria for study entry: • Willingness and the ability to provide signed informed consent Additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act authorization, and in other countries, as applicable according to national laws. • Age 18 years • Documented diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the American Diabetes Association or per WHO criteria and – Current regular use of insulin for the treatment of diabetes and/or – Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes • HbA1c of 10% within 2 months prior to the Day 1 visit date • Ability and willingness to undertake all scheduled visits and assessments • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion criteria
Exclusion criteria: • Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti diabetic medication or insulin within 3 months prior to Day 1 • History of allergy or hypersensitivity to active drug aflibercept and any of its excipients, fluorescein, or any study treatmentrelated mandatory ingredients. • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the RO6867461 or to aflibercept injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial drops used by a patient during the study • Active cancer within the past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of  6 and a stable prostate-specific antigen for  12 months • Systemic treatment for suspected or active systemic infection • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study • History of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the RO6867461 or aflibercept or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator • Uncontrolled blood pressure (defined as systolic 180 mmHg and/or diastolic 100 mmHg while a patient is at rest) • Cerebral vascular accident or myocardial infarction within 6 months prior to Day 1 • Pregnancy or breastfeeding, or intention to become pregnant during the study • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day 1 • Administration of systemic pro-angiogenic treatments, such as VEGF based therapies for the peripheral or coronary ischemia (e.g., limb ischemia or myocardial infarction) within 3 months or 5 half-lives prior to Day 1 • Inability to comply with study or follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline in BCVA (as measured on the ETDRS (ETDRS=Early Treatment Diabetic Retinopathy Study; FFA=fundus fluorescein angiography) chart at a starting distance of 4 meters) at 1 year a Measure:BCVA(best-corrected visual acuity) Timepoints:Throughout 100 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:To evaluate the efficacy of RO6867461 on anatomical outcome measures using SD OCT (Spectral-domain optical coherence tomography) Measure:Anatomical outcome measures using SD OCT (Spectral-domain optical coherence tomography) Timepoints:Throughout 100 weeks. ; Outcome name:To evaluate the efficacy of RO6867461 on patient-reported vision-related functioning and quality of life using the NEI VFQ-25 (National Eye Institute 25-Item Visual Function Questionnaire) Measure:NEI VFQ-25 (National Eye Institute 25-Item Visual Function Questionnaire) Timepoints:Throughout 100 weeks. | — |
Countries
Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, Djibouti, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactLizeth Perez
ROCHE FARMA (PERU) S.A.
Outcome results
None listed