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NCT03823287 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

A Phase 3 study of Wet Macular Degeneration, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
671
Enrollment target
20
Study locations

NCT03823287 is a Phase 3 study of Wet Macular Degeneration that has completed, run by Hoffmann-La Roche. The registered enrollment target is 671 participants, above the 139-participant average among 4 other Wet Macular Degeneration trials with a reported enrollment target (383% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT03823287, a Phase 3 study of Wet Macular Degeneration, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
671 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

Conditions Studied

Interventions

  • PROCEDURE Sham Procedure
  • DRUG Faricimab
  • DRUG Aflibercept

Study Locations (20)

California

  • Retinal Diagnostic Center - Campbell
  • The Retina Partners - Encino
  • Jacobs Retina center at the Shiley eye Institute UCSD - La Jolla
  • South Coast Retina Center - Long Beach
  • Southern CA Desert Retina Cons - Palm Desert
  • California Eye Specialists Medical group Inc. - Pasadena
  • Retina Consultants, San Diego - Poway
  • Retina Consultants of Southern California - Redlands
  • University of California, Davis, Eye Center - Sacramento

Florida

  • Rand Eye - Deerfield Beach
  • Florida Eye Associates - Melbourne
  • Retina Specialty Institute - Pensacola
  • Fort Lauderdale Eye Institute - Plantation
  • Retina Vitreous Assoc of FL - St. Petersburg

Arizona

  • Retinal Research Institute, LLC - Phoenix
  • Barnet Dulaney Perkins Eye Center - Phoenix
  • Retina Associates Southwest PC - Tucson

Colorado

  • Retina Consultants of Southern - Colorado Springs

Connecticut

  • Retina Group of New England - New London

Illinois

  • Northwestern Medical Group/Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 671 participants
Start Date 2019-02-19
Est. Completion 2022-01-18
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT03823287

The ClinicalTrials.gov registry entry for NCT03823287 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 671 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 139-participant average among 4 other Wet Macular Degeneration trials with a reported enrollment target (383% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Wet Macular Degeneration appearing as the primary indexed condition, and to 3 interventions - of which Sham Procedure is the first listed.

NCT03823287 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT03823287 about?

NCT03823287 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)". This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

What is the current status of trial NCT03823287?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2019-02-19. Estimated completion is 2022-01-18.

What conditions does trial NCT03823287 study?

This clinical trial studies the following conditions: Wet Macular Degeneration.

What interventions are being tested in trial NCT03823287?

The interventions under investigation include: Sham Procedure (PROCEDURE), Faricimab (DRUG), Aflibercept (DRUG).

Who is sponsoring clinical trial NCT03823287?

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

Where is trial NCT03823287 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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