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NCT02699450 · ClinicalTrials.gov registry record · Phase 2

A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
229
Enrollment target

NCT02699450: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT02699450 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 229 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02699450, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
229 participants
Enrollment target

Study 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.

Primary Outcome

Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct ca

Interventions

  • DRUG Faricimab
  • DRUG Ranibizumab

Trial Details

FieldValue
Enrollment Target 229 participants
Start Date 2016-04-27
Est. Completion 2017-12-14
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT02699450 record still lists

NCT02699450 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher).

The record links to 0 conditions, and to 2 interventions - of which Faricimab is the first listed.

NCT02699450 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02699450 about?

NCT02699450 is a clinical study titled "A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema". 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, th...

What is the current status of trial NCT02699450?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2016-04-27. Estimated completion is 2017-12-14.

What interventions are being tested in trial NCT02699450?

The interventions under investigation include: Faricimab (DRUG), Ranibizumab (DRUG).

Who is sponsoring clinical trial NCT02699450?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02699450's enrollment target sits among peer trials

229 264th of 2000 higher than 1,737 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02699450, the US trial registry maintained by the National Library of Medicine. NCT02699450 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.