Trials / Completed
CompletedNCT04740931
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 729 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faricimab | Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm. |
| DRUG | Aflibercept | Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). |
| PROCEDURE | Sham Procedure | The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2022-08-09
- Completion
- 2023-07-12
- First posted
- 2021-02-05
- Last updated
- 2024-08-06
- Results posted
- 2024-01-18
Locations
194 sites across 22 countries: United States, Argentina, Australia, Austria, Brazil, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04740931. Inclusion in this directory is not an endorsement.