Diabetic Macular Edema (DME) MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Product Name: Faricimab
Product Code: RO6867461
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Faricimab
CAS Number: 1607793-29-2
Current Sponsor code: RO6867461
Other descriptive na
Sponsors
F.Hoffmann La-Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Documented diagnosis of diabetes mellitus (Type 1 or Type 2) - Ability and willingness to undertake all scheduled visits and assessments - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment - Macular thickening secondary to DME involving the center of the fovea - Documented BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360
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 - Uncontrolled blood pressure - Pregnancy or breastfeeding, or intention to become pregnant during the study Ocular Exclusion Criteria for Study Eye - Treatment with panretinal photocoagulation within 3 months prior to Day 1 to the study eye - Macular laser within 3 months prior to Day 1 to the study eye - Any IVT or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye - Any use of medicated intraocular implants, including Ozurdex®, within 6 months of Day 1 and Iluvien® implants at any time prior to Day 1 to the study eye - Prior administration of IVT faricimab in either eye - Active intraocular or periocular infection or active intraocular inflammation in the study eye - Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye - Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of intravitreal (IVT) injections of faricimab on best-corrected visual acuity (BCVA) outcomes ;Secondary Objective: •To evaluate the efficacy of faricimab on diabetic retinopathy (DR) severity outcomes •To evaluate the efficacy of faricimab on additional BCVA outcomes •To evaluate the efficacy of faricimab on additional DR outcomes •To evaluate faricimab treatment intervals in the PTI arm •To evaluate the efficacy of faricimab on anatomical outcome measures using spectral-domain optical coherence tomography (SD OCT) •To evaluate the efficacy of faricimab on patient-reported vision-related functioning and quality of life using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) •To evaluate the ocular and systemic safety and tolerability of faricimab •To characterize the systemic pharmacokinetics of faricimab •To evaluate the immune response to faricimab •To evaluate potential effects of anti-drug antibodies (ADAs) ;Primary end point(s): 1. Change from baseline in BCVA at 1 year ;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with a >= 2-step DRS improvement from baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 year 2. Change from baseline in BCVA over time 3. Proportion of patients gaining >=15, >=10, >= 5, or >= 0 letters in BCVA from baseline over time 4. Proportion of patients avoiding a loss of >= 15, >= 10, >= 5, or > 0 letters in BCVA from baseline over time 5. Proportion of patients with a >= 2-step DRS improvement from baseline on the ETDRS DRSS over time 6. Proportion of patients with a >= 3-step DRS improvement from baseline on the ETDRS DRSS over time 7. Proportion of patients gaining >=15 letters or achieving BCVA of >= 84 letters over time 8. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time 9. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time 10. Proportion of patients who develop new PDR over time 11. Proportion of patients in the personalized treatment interval (PTI) arm on every 4, 8, 12 weeks or 16 weeks treatment interval at 1 year and 2 years 12. Treatment intervals in the PTI arm over time 13. Change from baseline in CST over time 14. Change from baseline in NEI VFQ-25 composite score over time 15. Proportion of patients with absence of DME over time 16. Incidence and severity of ocular adverse events 17. Incidence and severity of non-ocular adverse events 18. Plasma concentration of RO6867461 over time 19. Presence of ADAs during the study relative to the presence of ADAs at baseline 20. Relationship between ADA status and efficacy, safety, or PK endpoints 21. Change from baseline in CST at 1 year ;Timepoint(s) of evaluation of this end point: 1. At 1 year 2-6. Baseline to 2 years 7-10. Up to 2 years 11. At 1 and 2 years 12. Up to 2 years 13-14. Baseline to 2 years 15-18. Up to 2 year 16-18. Day 1, Week 4; Week 28; Week 52; Week 76; Week 100, at early termination visit | — |
Countries
Argentina, Australia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche LTD
Outcome results
None listed