Trials / Completed
CompletedNCT02699450
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 36-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Diabetic Macular Edema
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faricimab | Faricimab will be administered by IVT injection in the study eye. |
| DRUG | Ranibizumab | Ranibizumab will be administered by IVT injection in the study eye. |
Timeline
- Start date
- 2016-04-27
- Primary completion
- 2017-09-15
- Completion
- 2017-12-14
- First posted
- 2016-03-04
- Last updated
- 2020-09-25
- Results posted
- 2020-09-25
Locations
60 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02699450. Inclusion in this directory is not an endorsement.