Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Wet Macular Degeneration, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 an
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
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2022-01-18 |
| Phase | Phase 3 |
What the finished NCT03823287 record still lists
NCT03823287 is an interventional study that assigns participants to a tested intervention. The registered 671 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 4 other Wet Macular Degeneration trials with a reported enrollment target (383% higher).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
Similar trials for Wet Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
COMPLETED · Phase 3
-
Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD
COMPLETED · Phase 3
-
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07184944 · 671 participants · Phase 3
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
- NCT07185009 · 671 participants · Phase 3
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
- NCT05452031 · 672 participants · NA
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
- NCT05493254 · 672 participants · NA
Enhancing Smoking Cessation Via Telehealth Options in Primary Care
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI