A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia (POYANG)

June 5, 2026 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Strathfield, New South Wales, Australia, 2135
        • Strathfield Retina Clinic
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
      • Sydney, New South Wales, Australia, 2000
        • Sydney Retina Clinic and Day Surgery
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Centre For Eye Research Australia
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, China, 100730
        • Beijing Hospital of Ministry of Health
      • Beijing, China, 100730
        • Beijing Tong Ren Hospital, Capital Medical University
      • Changchun, China, 130041
        • The Second Hospital of Jilin University
      • Guangzhou, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Harbin, China, 150001
        • The 2nd Affiliated Hospital of Harbin Medical University
      • Qingdao, China, 265299
        • Qingdao Eye Hospital Of Shandong First Medical University
      • Shanghai, China, 200080
        • Shanghai First People's Hospital
      • Shanghai, China, 200030
        • Eye & ENT Hospital of Fudan University
      • Shenyang, China, 110001
        • First Hospital of China Medical University
      • Taiyuan, China, 030002
        • Shanxi Eye Hospital
      • Wenzhou, China, 325027
        • Eye Hospital, Wenzhou Medical University
      • Wuhan, China
        • Central Theater General Hospital of the Chinese People's Liberation Army
      • Wuxi, China, 214000
        • Wuxi No.2 People's Hospital
      • Xi'an, China
        • Xi'an People's Hospital (Xi'an Fourth Hospital)
  • France
      • Créteil, France, 94010
        • Chi De Creteil
      • Lyon, France, 69317
        • Hopital de la croix rousse
      • Marseille, France, 13008
        • Centre Paradis Monticelli
      • Nantes, France, 44093
        • CHU Nantes - Hotel Dieu
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75940
        • Fondation Rothschild
      • Saint-Cyr-sur-Loire, France, 37540
        • Centres Ophtalmologique St Exupéry
  • Germany
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Sulzbach, Germany, 66280
        • Knappschaftsklinikum Saar GmbH
  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
      • Mong Kok, Hong Kong
        • Hong Kong Eye Hospital
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Ospedale Clinicizzato SS Annunziata
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Policlinico di Bari
    • Campania
      • Naples, Campania, Italy, 80131
        • Ospedale Monaldi - AORN dei Colli
    • Lazio
      • Rome, Lazio, Italy, 00184
        • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
    • Lombardy
      • Milan, Lombardy, Italy, 20100
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
    • Veneto
      • Udine, Veneto, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine
  • Poland
      • Bydgoszcz, Poland, 85-631
        • OFTALMIKA Sp. z o.o
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
      • Krakow, Poland, 31-070
        • Centrum Medyczne UNO-MED
      • Lublin, Poland, 20-064
        • Gabinet Okulistyczny Jerzy Mackiewicz
      • Lódz, Poland, 91-134
        • Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 168751
        • Singapore Eye Research Institute
      • Singapore, Singapore, 258500
        • Asia Pacific Eye Centre
  • South Korea
      • Daegu, South Korea, 42415
        • Yeungnam University Medical Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 07301
        • Kim's Eye Hospital
  • Spain
      • Córdoba, Spain, 14012
        • Hospital de la Arruzafa. Servicio de Oftalmologia
      • Madrid, Spain, 28006
        • Oftalvist
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago.
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria De Navarra
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Zhongzheng Dist., Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia

  2. Diagnosis of active myopic CNV in the study eye:

    1. Presence of high myopia, worse than -6 diopters of spherical equivalence
    2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
    3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
    4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre [CRC])
    5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
  3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
  4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
  5. Ability to comply with the study protocol, in the Investigator's judgment
  6. Other protocol-defined inclusion criteria apply

Exclusion Criteria:

  1. Any major illness or major surgical procedure within 1 month before screening
  2. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
  3. Uncontrolled blood pressure (systolic >180 millimetres of mercury [mmHg], diastolic >100 mmHg)
  4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
  5. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
  6. Uncontrolled glaucoma in study eye
  7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
  8. Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye
  9. Other protocol-defined exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Faricimab
All participants randomly assigned to Arm A will receive faricimab 6 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with faricimab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
Drug: Faricimab
Faricimab 6 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.
Other Names:
  • RO6867461
  • RG7716
  • VABYSMO®
  • faricimab-svoa
Procedure: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants will undergo the sham procedure at study visits where no study drug is to be administered, in order to maintain masking.
Active Comparator: Arm B: Ranibizumab
All participants randomly assigned to Arm B will receive ranibizumab 0.5 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with ranibizumab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.
Procedure: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants will undergo the sham procedure at study visits where no study drug is to be administered, in order to maintain masking.
Drug: Ranibizumab
Ranibizumab 0.5 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
Time Frame: Baseline and Average of Weeks 4, 8, and 12
Baseline and Average of Weeks 4, 8, and 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in BCVA Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12
Time Frame: Baseline and Average of Weeks 4, 8, and 12
Baseline and Average of Weeks 4, 8, and 12
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48
Time Frame: From Baseline to Weeks 12, 24, and 48
From Baseline to Weeks 12, 24, and 48
Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48
Time Frame: From Baseline to Weeks 12, 24, and 48
From Baseline to Weeks 12, 24, and 48
Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12
Time Frame: Baseline and Average of Weeks 4, 8, and 12
Baseline and Average of Weeks 4, 8, and 12
Change from Baseline in CST of the Study Eye Over Time
Time Frame: From Baseline through Week 48
From Baseline through Week 48
Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48
Time Frame: Baseline, Weeks 12 and 48
Baseline, Weeks 12 and 48
Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48
Time Frame: Baseline, Weeks 12 and 48
Baseline, Weeks 12 and 48
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48
Time Frame: Weeks 12 and 48
Weeks 12 and 48
Incidence and Severity of Ocular Adverse Events
Time Frame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Incidence and Severity of Non-Ocular Adverse Events
Time Frame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Time Frame: At Baseline and from first dose until end of study (up to 48 weeks)
At Baseline and from first dose until end of study (up to 48 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR44829
  • 2023-506707-25-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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